Hello Everyone,
We have another exciting profile we want you to research for Mondy’s session.
This a company that we have never featured on our newsletter before.
It has closed green 5 of the last 7 and was up 13% today at the close on light interest.
Timing is everything and we think that we could be a good time to research this one.
It is under .55 right now with a 52 week high several hundred percent about it’s current levels.
Turn your attention to Nasdaq: BTCY.
Biotricity is reforming the healthcare market by bridging the gap in remote monitoring and chronic care management. Doctors and patients trust Biotricity’s unparalleled standard for preventive & personal care, including diagnostic and post-diagnostic solutions for chronic conditions. The company develops comprehensive remote health monitoring solutions for the medical and consumer markets.
There is an ongoing shift in healthcare towards preventive care, which Biotricity is leveraging to modernize chronic care & disease management.
The company believes its diagnostic and post-diagnostic solutions help reduce healthcare costs and detect anomalies earlier than existing monitoring solutions and provide faster and better reporting, as well. BTCY has expanded its salesforce in 2022 and targets further penetration into doctor’s offices and clinics with the recent launch of Biotres and the upcoming launch of other products. The company believes its tech platform is disrupting the traditional cardiac care model. With Biotricity’stechnology, cardiac patients can access advanced diagnostics from their homes using Biotricity devices, and thereby minimize visits to the cardiologist or hospital to times when therapeutic treatment or procedures are needed. The company’s lead product, Bioflux, is designed to detect an arrhythmia, heart attack, ventricular or atrial issue faster and transmit the information to a call center to prevent a traumatic health event faster than a conventional Holter device.
As BTCY moves to grow its share in the cardiac health cloud service niche, the company also seeks to expand horizontally beyond the cardiac market. Biotricity believes its emerging ecosystem offers a user- friendly platform that can be applied to help people suffering with diabetes, obesity, hypertension, sleep apnea, pain management and potentially many other areas.
The company launched Biotres earlier this year. It is a wearable wireless 3-lead patch device for continuous recording of ECG heart data and wider array of arrythmia monitoring.
As BTCY initiatives measures to grow its share in the cardiac health cloud service niche, the company also seeks to expand horizontally beyond cardiac and believes its emerging ecosystem offers a user-friendly platform that can be applied to monitor and assist people suffering with diabetes, obesity, hypertension, sleep apnea, pain management and potentially many other areas of healthcare management.
BTCY CATALYSTS
Unveiled our personal medical device kit, Biokit, for integration into our Biotricity ecosystem
Unveiled, Bioheart, a first-of-its kind continuous heart rhythm recorder and personal heart and lifestyle solution
The Company’s Bioheart personal cardiac monitor won TIME’s Best Inventions of 2022.
Awarded $250K NIH Grant from the National Heart, Blood, and Lung Institute for AI-Enabled real-time monitoring and predictive analytics for stroke due to chronic kidney failure.
Surpassed 2 billion recorded and analyzed heartbeats for atrial fibrillation (AFib).
Launched Biocare Cardiac Disease Management Solution after two successful pilots at Oklahoma & Kentucky Clinics.
Continued expansion of our network and maintenance of a 95+% retention rate that together drive Biotricity’s residual revenues.
Operating Highlights for the Q3-FY23 to Date
Signed agreements with two leading US medical device distributors and one GPO
Net loss totaled $4.75 million, or $0.091 per share
Biotricity signs distribution agreement with top 5 distributor for its Cardiac Monitoring Solutions
REDWOOD CITY, Calif., Jan 26, 2023 (ACCESSWIRE) — Biotricity Inc. (NASDAQ:BTCY) (“Biotricity” or the “Company”), a medical diagnostic and consumer healthcare technology company, today announced it has signed its second distribution agreement with a top five US medical device distributor for the marketing and distribution of its two cardiac monitoring solutions (CMS) designed for cardiologists’ patient use – Bioflux® and BiotresTM.
The distribution agreement covers Bioflux and Biotres and will be distributed directly to hospitals and clinics for professional medical utilization with suitable patients.
Commenting on the agreement, Biotricity Founder, Chairman and CEO Waqaas Al-Siddiq, Ph.D., said, “The future of healthcare lies with new, state-of-the-art technology that produces a more efficient and higher quality of care through remote care. That means tech that is specially designed for smart remote monitoring of individuals using digital/wireless and cloud-based technology with seamless integration with all platforms and devices.
“Our Bioflux and Biotres solutions address a market valued at $6 billion, and we fully expect to capture an increasing share of this growing marketplace,” Dr. Al-Siddiq added. “We are delivering cardiac care remotely, 24/7 and in real-time as needed, with technology that rivals existing standard of care solutions. Long term, we are confident our technology, and the lifestyle improvements it encourages will bend the curve of growing rates of heart disease.”
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Biotricity’s Enviably Massive Addressable Markets According to the World Health Organization, Cardiovascular diseases are the leading cause of death globally, taking an estimated 17.9 million lives each year. We are determined to reduce that number in a meaningful way, as our growing success addresses a heart rate monitoring devices market of $12.4 billion globally that analysts project reaching $17.1 billion in 2026. As a company, our focus is on expanding our total addressable market (TAM) by executing on our product portfolio. This will increase our TAM from $1.7 for cardiac devices to $55.9 Billion for Telemedicine andvcare management. Suffice to say, we have an enourmous opportunity ahead, I believe these forecasts are low and do not yet factor in our technology’s superior capabilities and industry & patient health, wellness, and lower-cost benefits.
Cost Savings & Workflow Time Efficiency for Nurses. Instead of expensive hospitals and emergency room bills, pro-active monitoring and early detection of medicine need or surgery allows outpatient cost savings. Remote monitoring allows cost-effective at $11,000/year (NIH/Journal of Cardiovascular Electrophysiology) per patient year.
Reimbursement rates reduction or cut risk from Medicare is minimal exposure for Biotricity and its physicians network. Bioflux and the recently launched Biotres patch already fit into the existing billing codes and resilient clinical fee. Biotricity’s wheelhouse is more insulated because no reimbursement specialist is needed for billing and reads are insurance reimbursable.
Recurring revenue play and easily deployable tech. There is also lower operational expense for the doctors and clinics, along with easy integration into their back offices. Rechargeable devices help keep the margins high and further insulate from reimbursement.
Detection & Accuracy are improved with Bioflux compared to conventional products. Artificial Intelligence (AI) and Biotricity’s database on nearly 100,000 patients of ECG data can identify ECG abnormalities with 90%+ accuracy and speed up response time, according to BTCY.
Beneficiary of the ongoing shift to remote monitoring of outpatients and improved efficiency for doctors and nurses workflow. Physicians benefit from earlier detection of patient’s heart issues, improved workflow and efficiencies with Biotricity’s software and automation. The physician can increase their own annual revenues by approximately $180,000-260,000 as seen below.
Biotricity reports financial results for Fiscal 2023 Third Quarter
REDWOOD CITY, Calif., Feb 14, 2023 (ACCESSWIRE) — Biotricity Inc. (NASDAQ:BTCY) (“Biotricity” or the “Company”), a medical diagnostic and consumer healthcare technology company, today announced its financial results and provided a business update for its third quarter of fiscal 2023 ended December 31, 2022.
Commenting, Dr. Waqaas Al-Siddiq, Biotricity Founder & CEO, said, “With our suite of state-of-the-art remote cardiac solutions now well established, Biotricity is focused on sales, marketing and achieving positive cash flow.
In just the past three months, we have successfully signed agreements with two leading US medical device distributors and one Group Purchasing Organization (GPO) as major components of our go-to market strategy and growing marketplace prominence. In total, just in the US alone, they cover over $20 billion in annual purchasing. We are actively considering adding similar distributors with geographic or vertical coverage that complement our existing networks.
“Technologically, we are increasingly leaning into AI with its data and predictive capability to target more pervasive forms of patient monitoring and lifestyle management. Our enviable 98 percent customer retention rate succinctly reflects our strong competitive position. It also ensures our customers’ lifetime value is high and drives our growing ‘technology-as-a-service’ base of recurring revenue.
“Financially, we reported strong sales revenue growth of 27.4 percent year-over-year, and a gross margin of 57 percent as our business scales, while narrowing the net loss by one third. In calendar year 2023, we plan to trim R&D and capex while continuing to innovate products and services centered around our cloud-based Biosphere cardiac ecosystem — to reduce the overall price of unrivaled cardiac care while positively transforming the efficacy of its delivery and outcomes.
“Looking ahead, we are focused on increasing market penetration through additional distribution agreements, highly targeted advertising, industry conference and tradeshow participation, and building our sales and marketing team one carefully selected professional at a time, all while managing cash flow to accelerate our path to profitability.”
Operating Highlights for the Q3-FY23 to Date
Signed agreements with two leading US medical device distributors and one GPO
Net loss totaled $4.75 million, or $0.091 per share
Full details of the Company’s financial results will be filed with the SEC on Form 10-Q, and are available at no cost by visiting www.sec.gov.
Financial Results Conference Call
Management will host a conference call on Tuesday, February 14, 2023 at 4:30 p.m. ET to discuss its financial results for the fiscal 2023 third quarter and provide a business update. Additional details are available under the Investor Relations section of the Company’s website: https://www.biotricity.com/investors/
Biotricity Product RoadmapBioflux® is their flagship product. It is a high-precision, single-unit mobile cardiac telemetry (MCT) device that provides real-time monitoring and transmission of ambulatory patients’ ECG information.
Disruptive Business Model
Insourced business model, enabling physicians to bill directly
Minimal upfront cost for physician, physician pays only when device is used – top line profit
Turn-key solution for physicians
Recurring revenue with high margin for Biotricity
Reads are insurance reimbursable using existing CPT billing codes
Turn-key solution: device, software, and monitoring center • One piece device that is the smallest in the market
Built-in global GPS and GSM platform
CURRENT FOOTPRINT FOR BIOFLUX
Biotres is a three-lead patch solution for real-time and passive arrhythmia monitoring designed for patients who are at risk for, or diagnosed with, certain cardiac issues. It can operate as a Holter, Event Loop, and potentially as a wireless patch in conjunction with Bioflux for MCT. Biotres has been filed with the FDA and is pending approval.
Biocare® Telemed is a virtual clinic platform with secure HIPAA-compliant technology that enables clinicians to provide outstanding patient care remotely, ensuring their at-risk patients and those needing remote cardiac monitoring do not have to leave the safety and comfort of their home. Today, the Biocare app is used by our customer clinics to service their patients. Going forward, it will become a virtual cardiac clinic where individuals looking for a cardiologist will be able to access our network of cardiologists. To achieve this, we are currently interconnecting our customer clinics to create one large virtual cardiac clinic, which we expect to launch in the second half of 2022. This will enable individuals looking for a cardiologist to access one that uses the Biotricity eco-system of diagnostics and disease management technology. Biokit is a personal medical device kit, a bundled home-use set comprised of a digital thermometer, a pulse oximeter, and a blood pressure cuff. It is FDA cleared, wireless capable and readily integrates into the Biotricity eco-system. Introduced in September, it is slated for a 1Q-22 launch. With Bioflux and Biokit combined, we will soon offer a comprehensive cardiac diagnostics and management product line for effective, accurate and economic long-term disease management.
Bioheart is for consumers seeking self-management of pre-diagnosis heart health, wellness and preventative care. Consumers can share data with their physicians if they choose. Following strong sales during its pre-release period, we launched Bioheart earlier this month – ahead of schedule – and plan to ramp up its marketing campaign throughout 2022.
Biotricity surpasses $10 million in annual revenue run rate
REDWOOD CITY, Calif., Nov 21, 2022 (ACCESSWIRE) — Biotricity Inc. (NASDAQ:BTCY) (“Biotricity” or the “Company”), a medical diagnostic and consumer healthcare technology company, today announced it has surpassed $10 million in annual revenue run rate. “With strong revenue growth each quarter, our scale and market reach increases every day,” says Biotricity Founder and CEO, Dr. Waqaas Al-Siddiq. “I am committed to continuing to drive growth and realize our potential. Our focus remains on providing the cardiac health market with disruptive, superior digital and AI technology at competitive pricing with unrivaled support to our customers and physician partnerships.” Biotricity boasts multiple ground-breaking products including Bioflux®, Biotres, and Bioheart which won TIME’s Best Inventions of 2022.
Bioflux: a high-precision, single-unit mobile cardiac telemetry (MCT) device that provides real-time monitoring and transmission of your ECG information to your doctor
Biotres: an easy to wear, rechargeable device with wireless capability, utilizing the advanced technology of the Bioflux® for more active days
Bioheart: a consumer-targeted continuous heart rhythm monitor that uses the most advanced heart technology to deliver unlimited heart data insights with three views of your heart
The record revenue run rate is Biotricity’s latest achievement in a string of major milestones that include:
The Company’s Bioheart personal cardiac monitor won TIME’s Best Inventions of 2022
Awarded $250K NIH grant from the National Heart, Blood, and Lung Institute for AI-enabled real-time monitoring and predictive analytics for stroke due to chronic kidney failure
Surpassed 2 billion recorded and analyzed heartbeats for atrial fibrillation (A-fib)
Company has delivered revenue growth in nine out of the last ten consecutive quarters
Biotricity’s Bioheart named to TIME’s list of The Best Inventions of 2022
Bioheart provides consumers the most advanced personal heart monitoring technology, combining powerful analytics and continuous heart monitoring for personalized heart insights
November 10, 2022 | REDWOOD CITY, Calif., Nov 10, 2022 (ACCESSWIRE) — Biotricity Inc. (NASDAQ:BTCY) (“Biotricity” or the “Company”), a medical diagnostic and consumer healthcare technology company, today announced that its Bioheart device has been named to TIME’s list of the Best Inventions of 2022. Bioheart is the first of its kind – a continuous heart rhythm monitor using advanced technology to deliver unlimited heart data insights.
Cardiac issues are intermittent, often asymptomatic, and lifelong in nature, requiring continuous heart activity monitoring. Fitness trackers simply collect your heart rate and personal ECG devices manually collect a few minutes of data, leaving you without the full picture. Bioheart changes everything by creating the first heart activity monitor. Whether you are sleeping, sitting, or out exploring the world, Bioheart’s uninterrupted monitoring keeps you informed about your heart 24/7. TIME reveals its annual list of the Best Inventions, which features 200 extraordinary innovations changing our lives: time.com/best-inventions-2022. To compile the list, TIME solicited nominations from TIME’s editors and correspondents around the world, as well as through an online application process, paying special attention to growing fields-such as the electric vehicle industry, green energy, and the metaverse. TIME then evaluated each contender on a number of key factors, including originality, efficacy, ambition, and impact. Of the New Best Inventions list, TIME’s editors wrote: “The result is a list of 200 groundbreaking inventions (and 50 special mention inventions)- including life-mapping artificial intelligence, diamonds made from excess carbon in the air, and the most powerful telescope ever-that are changing how we live, work, play, and think about what’s possible.” “We are honored and excited to have our premier consumer product, Bioheart, included in TIME’s 2022 list,” commented Dr. Waqaas Al-Siddiq, Founder and CEO of Biotricity. “Our mission is to disrupt and transform the state of cardiac health and wellness, worldwide. Bioheart is the beginning of this journey”
ANALYST RATINGS
There are several analysts with price targets on BTCY well above it’s current levels of a dollar. They all represent 300%+ moves from it’s current levels if the analysts turn out to be right.
(sourced from MarketBeat)
Biotricity surpasses 2 billion recorded and analyzed heartbeats for atrial fibrillation (AFib)
Data set of 2 billion heartbeats and growing allows Biotricity to scale faster and operate more efficiently with better automation, yielding growth and better margins in the future
REDWOOD CITY, Calif., Oct 04, 2022 (ACCESSWIRE) — Biotricity Inc. (NASDAQ:BTCY) (“Biotricity” or the “Company”), a medical diagnostic and consumer healthcare technology company, today announced a significant milestone of recording and analyzing over 2 billion heartbeats for Atrial Fibrillation (AFib), the most common type of cardiac arrhythmia and a leading cause of stroke. Bioflux®, Biotricity’s high-precision, single-unit mobile cardiac telemetry device that provides real-time monitoring and transmission of the patient’s ECG information, has captured billions of heartbeats to date, monitored in real-time by Bioflux’s built in algorithms, certified cardiac technicians and benchmarked by Artificial Intelligence (AI). Leveraging the Company’s proprietary AI, over 2 billion of the total heartbeats to date have been segmented for AFib analysis. According to Emergen Research, the global recurrent market for AFib is expected to reach USD$26 billion by 2027, growing at a CAGR of 13.2%. This large data set provides further benefits for patients, providers and ultimately clinical research for the future of predictive monitoring. Additionally, it allows Biotricity to scale faster and operate more efficiently, develop better automation, yielding growth and better margins in the future. The consistent focus on R&D and data capture has positioned Biotricity with a significant competitive advantage in key cardiac segments of the market, such as AFib. Dr. Waqaas Al-Siddiq, Founder & CEO of Biotricity, commented, “AFib unfortunately continues to be a leading cardiac risk globally, growing annually at alarming rates. We have purposely designed our ecosystem to monitor the patient 24/7 while leveraging our innovative technology that uniquely combines AI with data and predictive capabilities. In doing so, we can create better and faster analytics for preventative patient monitoring and lifestyle management. For AFib specifically, the ability to significantly narrow the time of diagnosis reduces risk for the patient and liability for the provider, giving our technology the ability to positively impact millions who suffer with AFib globally. Additionally, as we continue to collect more data through our R&D efforts, our internal quality review process will scale and further increase in efficiency, allowing us to continue to grow our margins.”
REDWOOD CITY, Calif., Apr 11, 2023 (ACCESSWIRE) — Biotricity Inc. (NASDAQ:BTCY) (“Biotricity” or the “Company”), a leading medical diagnostic and consumer healthcare technology…
REDWOOD CITY, Calif., Mar 07, 2023 (ACCESSWIRE) — Biotricity Inc. (NASDAQ:BTCY) (“Biotricity” or the “Company”), a medical diagnostic and consumer healthcare technology company,…
REDWOOD CITY, Calif., Feb 14, 2023 (ACCESSWIRE) — Biotricity Inc. (NASDAQ:BTCY) (“Biotricity” or the “Company”), a medical diagnostic and consumer healthcare technology company,…
REDWOOD CITY, Calif., Feb 09, 2023 (ACCESSWIRE) — Biotricity Inc. (NASDAQ:BTCY) (“Biotricity” or the “Company”), a medical diagnostic and consumer healthcare technology company,…
REDWOOD CITY, Calif., Feb 03, 2023 (ACCESSWIRE) — Biotricity Inc. (NASDAQ:BTCY) (“Biotricity” or the “Company”), a medical diagnostic and consumer healthcare technology company,…
REDWOOD CITY, Calif., Jan 26, 2023 (ACCESSWIRE) — Biotricity Inc. (NASDAQ:BTCY) (“Biotricity” or the “Company”), a medical diagnostic and consumer healthcare technology company,…
REDWOOD CITY, Calif., Jan 23, 2023 (ACCESSWIRE) — Biotricity Inc. (NASDAQ:BTCY) (“Biotricity” or the “Company”), a medical diagnostic and consumer healthcare technology company,…
REDWOOD CITY, Calif., Jan 17, 2023 (ACCESSWIRE) — Biotricity Inc. (NASDAQ:BTCY) (“Biotricity” or the “Company”), a medical diagnostic and consumer healthcare technology company,
REDWOOD CITY, Calif., Dec 12, 2022 (ACCESSWIRE) — Biotricity Inc. (NASDAQ:BTCY) (“Biotricity” or the “Company”), a medical diagnostic and consumer healthcare technology company,…
REDWOOD CITY, Calif., Nov 21, 2022 (ACCESSWIRE) — Biotricity Inc. (NASDAQ:BTCY) (“Biotricity” or the “Company”), a medical diagnostic and consumer healthcare technology company,…
REDWOOD CITY, Calif., Nov 18, 2022 (ACCESSWIRE) — Biotricity Inc. (NASDAQ:BTCY) (“Biotricity” or the “Company”), a medical diagnostic and consumer healthcare technology company,…
REDWOOD CITY, Calif., Nov 16, 2022 (ACCESSWIRE) — Biotricity Inc. (NASDAQ:BTCY) (“Biotricity” or the “Company”), a medical diagnostic and consumer healthcare technology company,…
REDWOOD CITY, Calif., Nov 14, 2022 (ACCESSWIRE) — Biotricity Inc. (NASDAQ:BTCY) (“Biotricity” or the “Company”), a medical diagnostic and consumer healthcare technology company,…
REDWOOD CITY, Calif., Nov 10, 2022 (ACCESSWIRE) — Biotricity Inc. (NASDAQ:BTCY) (“Biotricity” or the “Company”), a medical diagnostic and consumer healthcare technology company,…
REDWOOD CITY, Calif., Nov 01, 2022 (ACCESSWIRE) — Biotricity Inc. (NASDAQ:BTCY) (“Biotricity” or the “Company”), a medical diagnostic and consumer healthcare technology company,…
REDWOOD CITY, Calif., Oct 26, 2022 (ACCESSWIRE) — Biotricity Inc. (NASDAQ:BTCY) (“Biotricity” or the “Company”), a medical diagnostic and consumer healthcare technology company,…
REDWOOD CITY, Calif., Oct 11, 2022 (ACCESSWIRE) — Biotricity Inc. (NASDAQ:BTCY) (“Biotricity” or the “Company”), a medical diagnostic and consumer healthcare technology company,…
REDWOOD CITY, Calif., Nov 21, 2022 (ACCESSWIRE) — Biotricity Inc. (NASDAQ:BTCY) (“Biotricity” or the “Company”), a medical diagnostic and consumer healthcare technology company,…
REDWOOD CITY, Calif., Oct 04, 2022 (ACCESSWIRE) — Biotricity Inc. (NASDAQ:BTCY) (“Biotricity” or the “Company”), a medical diagnostic and consumer healthcare technology company,…
REDWOOD CITY, Calif., Sep 07, 2022 (ACCESSWIRE) — Biotricity Inc. (NASDAQ:BTCY) (“Biotricity” or the “Company”), a medical diagnostic and consumer healthcare technology company,…
REDWOOD CITY, Calif., Aug 15, 2022 (ACCESSWIRE) — Biotricity Inc. (NASDAQ:BTCY) (“Biotricity” or the “Company”), (“Biotricity” or the “Company”), a medical diagnostic and…
Management Team
Dr. Waqaas Al-Siddiq, Phd
Chairman, CEO & Founder
Waqaas, the founder of Biotricity, is a serial entrepreneur, a former investment advisor and an expert in wireless communication technology. Academically, he was distinguished for his various innovative designs in digital, analog, embedded, and micro-electro-mechanical products. His work was published in various conferences such as IEEE and the National Communication Council. Waqaas has held several high-level design positions in IBM, AMD, and Intel. His achievements have been numerous in both the technical and academic world. Coupled with this, Waqaas has vast experience in leading various groups through his board experience and executive roles within start-ups, mid-sized companies, and non-profits. Waqaas has a dual Bachelor’s degree in Computer Engineering and Economics, a Master’s in Computer Engineering from Rochester Institute of Technology, and a Master’s in Business Administration from Henley Business School. He also holds a Doctorate in Business with a specialty in Transformative Innovations and Billion Dollar Markets.
Norman Betts, Phd
Independent Board Member
Norman sits on the Boards of Directors of the Bank of Canada, Tembec Inc., New Brunswick Power Corporation, 49 North Resources Inc., Adex Mining Inc., Tanzanian Royalty Exploration Inc. and the University of New Brunswick Pension Plan for Academic Employees. Norman is an Associate Professor in the Faculty of Business Administration at the University of New Brunswick in Fredericton. He is accomplished in the field of accounting and finance, with a mix of academic, public, and private-sector experience. He is an expert in accounting regulations, and has extensive experience in audits, risk management, governance and oversight. He was a member of the New Brunswick Legislative Assembly from 1993 to 2003 and held three different cabinet posts, including Minister of Finance from 1999 to 2001. Prior to entering politics, Norman was Assistant Dean of the MBA Programme and an Associate Professor at the University of New Brunswick as well as a partner in the accounting firm Shannon, Betts & Buffett. Norman received a PhD in Management with a concentration in accounting and finance from Queen’s University School of Business in 1992 and a Bachelor of Business Administration from the University of New Brunswick in 1978. He also holds a Fellow Chartered Accountant designation.
Dave Rosa
Independent Board Member
Dave has spent the past 22 years in a variety of positions in the medical device industry. He was appointed CEO of Sunshine Heart in October of 2009 and served as President and Chief Executive Officer through November 2015. Dave took Sunshine Heart Public on NASDAQ in 2012 and raised over $120M during his tenure. The Company achieved a number of clinical, regulatory and research and development milestones under his leadership. Prior to joining Sunshine Heart, he was President and CEO of Milksmart, Inc., a privately held company developing a unique stent-like agricultural technology that increases milking efficiencies, output and quality. From 2004-2008, Dave was Vice President of Global Marketing for Cardiac Surgery and Cardiology at St. Jude Medical, Inc. While at St. Jude, he developed the strategic pan for the newly formed interventional division, directed the launch of several new products and oversaw the acquisition and integration of Velocimed, a privately held company in the cardiovascular space. From 1999-2004, Dave held executive management positions at privately held A-Med Systems, Inc., an emerging medical technology company that developed ventricular assist devices (pVADs) for acute heart failure. His roles included Vice President of Marketing and Sales, Chief Operating Officer and Chief Executive Officer. From 1995- 1999, Dave served as Product Manager for Angioplasty Balloons and Director of Intravascular Ultrasound at SCIMED Life Systems, a privately held company that was engaged in the development, manufacture and marketing of medical devices to treat cardiovascular disease. SCIMED was acquired by Boston Scientific Corporation and now operates as a subsidiary of Boston Scientific. Dave holds an M.B.A. in Marketing Management from Duquesne University and a B.S. in Commerce and Engineering from Drexel University.
Patricia Kennedy
Independent Board Member
Patricia has spent over 25 years in a variety of global sales and distribution positions in the medical device industry, focusing on the field of Electrophysiology. In 2015, she founded and is currently the Managing Director of PJM Medical Consultants, supporting medical device companies entering the international market with market entry and product commercialization strategies. From 2008 to 2015, Pat served as VP – International and General Manager for Atricure, Inc. She achieved significant sales, market development and clinical science milestones, while defining strategic plans and pursuing technology development and acquisitions. From 2001 to 2008, Pat worked with Stereotaxis, Inc. in numerous executive positions including Worldwide VP – Clinical Services and VP – International Sales and Marketing. Prior to Stereotaxis, Pat worked with EP MedSystems as International Marketing Manager for defibrillation and diagnostic catheters. She began her career in the medical industry at Boston Scientific from 1992 to 1997 while serving in several positions, including Sales and International Product Manager for EPT. Pat has earned a Bachelor of Science Degree in Marketing from the University of Florida and a Bachelor of Science in Nursing degree from the University of North Florida.
Steve Salmon
Independent Board Member
Steve Salmon has expertise in business development transactions, market development, finance, technology, and capital market. His most recent experience was as a Venture Capitalist for Latterell Venture Partners, where he managed a number of portfolio companies. Prior to becoming a VC, Mr. Salmon was a founder of Ensure Medical and Integrated Vascular Systems, both of which were successfully exited through acquisition. He also served as the CEO of Revascular which was also acquired. Mr. Salmon brings to Biotricity his deep expertise in raising capital, facilitating growth, and driving long term value.
John Ayanoglou
Chief Financial Officer
John has over 25 years of accounting, finance, and operations experience, having previously served as CFO of several public companies and a regulated financial institution. As CFO of Equitable Group, Mr. Ayanoglou raised over $130 million of regulatory capital in common, preferred, and debenture offerings over successive transactions, all during a period of extreme capital market turbulence, helping to successfully grow assets under administration from $6.1 billion to over $10 billion to facilitate Equitable Bank in becoming Canada’s ninth largest bank. He was also the CFO and Corporate Secretary of Xceed Mortgage Corporation, where he partnered with an entrepreneurial top team to grow the business through the successful implementation of warehouse financing lines and other securitization programs including public term securitizations of over $700 million. John has extensive experience as a trusted business advisor working with management teams and boards on business acquisition and consolidation, risk mitigation and turnaround, to establish efficient, effective operations. He is a CA, CPA with a Bachelor of Commerce degree in Finance and Economics from the University of Toronto and his ICD.D designation from the Institute of Corporate Directors and the Rotman School of Business.
Amir Ali
Chief Development Officer
Amir is a serial entrepreneur with over 20 years of experience in launching companies and producing innovative products, services, and solutions. Amir is sought after for his expertise in transforming R&D technologies into products based on market needs, commercializing products for volume production, and establishing global distribution channels across the world. Prior to joining Biotricity, Amir served as CEO at AT Labs Inc., where his team pioneered the concept of wireless mobile thin clients to access secure enterprise applications through the cloud. The efficacy of the robust solutions resulted in customers from healthcare, government, enterprise, and retail sectors, most of which spanned thousands of locations across the United States. His experience in developing such novel technologies has put him at the forefront of companies that have grown in revenue from zero to over $160 million. In his own ventures, he has worked with many leading industrial and financial institutional funders including Jafo, Bay Partners, and JP Morgan with whom he has raised over $35 million.
Spencer LaDow
Vice President, Engineering
Spencer is an expert in wireless communication and has worked with the United States Department of Defense. His academic career was highlighted by various innovative projects and designs. Spencer obtained his undergraduate degree while balancing a full-time job at Flightline Systems Ultra Electronics, a small defense contractor. His specialties are in the design and implementation of radio frequency, digital, analog, embedded software and PC software. Spencer also has experience in working with marketing, sales, and manufacturing teams in order to develop products for large-scale output. Spencer has a Bachelor’s degree in Computer Engineering from Rochester Institute of Technology.
Advisory Board
Thomas C. Nelson
Nelson serves as the president of Share Our Strength, a national nonprofit that is ending childhood hunger in America. Prior to joining Share Our Strength in 2011, Nelson was chief operating officer for AARP, where he led the build-out of its state strategy in all 53 US states and territories. In addition to serving as an adjunct professor at Georgetown University’s McDonough School of Business, Nelson has a long history of service to civic organizations, including his current position on the board of directors of ProInspire. Other board positions include, the board of counselors for the Davis Gerontology School at the University of Southern California; the board of the Certified Financial Planner Board of Standards; and the board of Community Wealth Partners. Nelson holds a Ph.D. from the University of Southern California and an M.A. from Columbia University.
John Rother, JD
Mr. Rother is President and CEO of the National Coalition on Health Care, America’s oldest and most diverse group working to achieve comprehensive health system change. Prior to joining the Coalition in 2011, Rother worked at AARP for over 27 years as the Executive Vice President for Policy, Strategy, and International Affairs where he led the development of AARP’s policy positions and advocacy strategies. Under his leadership, AARP engaged in public policy research and analysis, public education, and advocacy on health and retirement issues at the federal, state and international levels. Rother wrote numerous articles and was a frequent speaker on health, retirement security, the federal budget, and the boomer generation. Prior to that, Rother was Staff Director and Chief Counsel for the U.S. Senate Special Committee on Aging under the direction of Chairman John Heinz and served as Special Counsel for Labor and Health to U.S. Senator Jacob Javits. He has consistently been named as one of the most powerful people in Healthcare and in 2010 received the Robert Ball Award for Outstanding Achievements in Social Insurance from the National Academy of Social Insurance for “lifetime advocacy to strengthen Social Security and Medicare.”
Daniel Sands, MD, MPH
Dr. Sands is passionate about healthcare transformation, non-visit based care, collaboration in healthcare, and participatory medicine. He spent six years at Cisco, as chief medical informatics officer, where he provided both internal and external health IT leadership and helped key customers with business and clinical transformation using IT. Sands’ prior position was chief medical officer for Zix Corporation, a leader in secure e-mail and e-prescribing. Sands also spent 13 years at Beth Israel Deaconess Medical Center in Boston, where he developed and implemented numerous systems to improve clinical care delivery and patient engagement. He has earned degrees from Brown University, Ohio State University and the Harvard School of Public Health, and trained at Boston City Hospital and Boston’s Beth Israel Hospital. Sands currently holds an academic appointment at Harvard Medical School and maintains a primary care practice in which he makes extensive use of health IT. He works as a consultant for a variety of innovative companies. Sands is the recipient of numerous health IT awards, has been elected to fellowship in both the American College of Physicians and the American College of Medical Informatics, and is a founder and co-chair of the board of the Society for Participatory Medicine. In 2009, he was recognized by HealthLeaders Magazine as one of “20 People Who Make Healthcare Better.”
Sincerely,
Disclaimer:
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READERS ARE ADVISED TO REVIEW SEC PERIODIC REPORTS: FORMS 10-Q, 10K, FORM 8-K, INSIDER REPORTS, FORMS 3, 4, 5 SCHEDULE 13D.DEDICATED INVESTORS, LLC IS COMPLIANT WITH THE CAN SPAM ACT OF 2003. DEDICATED INVESTORS LLC DOES NOT OFFER SUCH ADVICE OR ANALYSIS, AND DEDICATED INVESTORS LLC FURTHER URGES YOU TO CONSULT YOUR OWN INDEPENDENT TAX, BUSINESS, FINANCIAL AND INVESTMENT ADVISORS. INVESTING IN MICRO-CAP AND GROWTH SECURITIES IS HIGHLY SPECULATIVE AND CARRIES AND EXTREMELY HIGH DEGREE OF RISK. IT IS POSSIBLE THAT AN INVESTORS INVESTMENT MAY BE LOST OR IMPAIRED DUE TO THE SPECULATIVE NATURE OF THE COMPANIES PROFILED.THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995 PROVIDES INVESTORS A SAFE HARBOR IN REGARD TO FORWARD-LOOKING STATEMENTS. ANY STATEMENTS THAT EXPRESS OR INVOLVE DISCUSSIONS WITH RESPECT TO PREDICTIONS, EXPECTATIONS, BELIEFS, PLANS, PROJECTIONS, OBJECTIVES, GOALS, ASSUMPTIONS OR FUTURE EVENTS OR PERFORMANCE ARE NOT STATEMENTS OF HISTORICAL FACT MAY BE FORWARD LOOKING STATEMENTS. FORWARD LOOKING STATEMENTS ARE BASED ON EXPECTATIONS, ESTIMATES, AND PROJECTIONS AT THE TIME THE STATEMENTS ARE MADE THAT INVOLVE A NUMBER OF RISKS AND UNCERTAINTIES WHICH COULD CAUSE ACTUAL RESULTS OR EVENTS TO DIFFER MATERIALLY FROM THOSE PRESENTLY ANTICIPATED. FORWARD LOOKING STATEMENTS IN THIS ACTION MAY BE IDENTIFIED THROUGH USE OF WORDS SUCH AS PROJECTS, FORESEE, EXPECTS, WILL, ANTICIPATES, ESTIMATES, BELIEVES, UNDERSTANDS, OR THAT BY STATEMENTS INDICATING CERTAIN ACTIONS & QUOTE; MAY, COULD, OR MIGHT OCCUR. UNDERSTAND THERE IS NO GUARANTEE PAST PERFORMANCE WILL BE INDICATIVE OF FUTURE RESULTS. IN PREPARING THIS PUBLICATION, DEDICATED INVESTORS LLC HAS RELIED UPON INFORMATION SUPPLIED BY ITS CUSTOMERS, PUBLICLY AVAILABLE INFORMATION AND PRESS RELEASES WHICH IT BELIEVES TO BE RELIABLE; HOWEVER, SUCH RELIABILITY CANNOT BE GUARANTEED. INVESTORS SHOULD NOT RELY ON THE INFORMATION CONTAINED IN THIS WEBSITE. RATHER, INVESTORS SHOULD USE THE INFORMATION CONTAINED IN THIS WEBSITE AS A STARTING POINT FOR DOING ADDITIONAL INDEPENDENT RESEARCH ON THE FEATURED COMPANIES. DEDICATED INVESTORS LLC HAS NOT BEEN COMPENSATED FOR THIS EMAIL. THE ADVERTISEMENTS IN THIS WEBSITE ARE BELIEVED TO BE RELIABLE, HOWEVER, DEDICATED INVESTORS LLC AND ITS OWNERS, AFFILIATES, SUBSIDIARIES, OFFICERS, DIRECTORS, REPRESENTATIVES AND AGENTS DISCLAIM ANY LIABILITY AS TO THE COMPLETENESS OR ACCURACY OF THE INFORMATION CONTAINED IN ANY ADVERTISEMENT AND FOR ANY OMISSIONS OF MATERIALS FACTS FROM SUCH ADVERTISEMENT. DEDICATED INVESTORS LLC IS NOT RESPONSIBLE FOR ANY CLAIMS MADE BY THE COMPANIES ADVERTISED HEREIN, NOR IS DEDICATED INVESTORS LLC RESPONSIBLE FOR ANY OTHER PROMOTIONAL FIRM, ITS PROGRAM OR ITS STRUCTURE. DEDICATED INVESTORS LLC IS NOT AFFILIATED WITH ANY EXCHANGE, ELECTRONIC QUOTATION SYSTEM, THE SECURITIES EXCHANGE COMMISSION OR FINRA.
150 Employees, Serving 5,000 Brands in 20 Countries
The Entire Float is Under 4Million According to Yahoo Finance
Yahoo Also Has Revenues Over $130 Million for 2022
______________
Hello Everyone,
We have another low float profile for todays session.
Pull up KSPN Immediately and start your research.
Kaspien Holdings Inc. (f/k/a Trans World Entertainment Corporation) (NASDAQ:KSPN) is a leading ecommerce marketplace growth platform, offering an expanding suite of software and services to help brands grow on Amazon, Walmart, Target, eBay, and other online marketplaces. Founded in 1972 as a brick-and-mortar retailer and rebranded as Kaspien in 2020, the Company has spent the last decade building and utilizing proprietary technologies for brand protection, marketing optimization, and fulfillment efficiency to generate rapid revenue growth for its partners. Through innovative strategies and best-in-class technologies, Kaspien has earned the trust of many leading brands, including 3M, Strider Bikes, and ZippyPaws. For more information, visit kaspien.com.
Brock provides financial thought leadership to Kaspien, drawing on his background in funding, trading, and strategy at Goldman Sachs to spur meaningful improvements across the company. Brock’s non-traditional finance background of aerospace engineering and data science equips him with a unique lens from which to question the status quo and drive financial performance.
Lisa Wideman
CHIEF PEOPLE OFFICER
Lisa maintains a keen focus on the Human Resources Mission Statement: “To Maximize the Potential of our Biggest Asset – Our Employees.” With over 15 years in human resources, Lisa brings innovative ways to drive employee engagement and ensure a positive experience throughout the employee lifecycle.
Ed Sapienza
CHIEF FINANCIAL OFFICER
Ed began his career with Kaspien Holdings in 1993 and has served in positions of increasing responsibility, including Manager and Director of External Reporting, Director of Financial Planning, and Vice President of Strategy & Finance, along with being the Company Secretary before his most recent promotion to Chief Financial Officer in 2018.
Sincerely,
DISCLAIMER
THIS WEBSITE/NEWSLETTER IS OWNED SUBSIDIARY BY DEDICATED INVESTORS, LLC.
OUR REPORTS/RELEASES ARE A COMMERCIAL ADVERTISEMENT AND ARE FOR GENERAL INFORMATION PURPOSES ONLY. WE ARE ENGAGED IN THE BUSINESS OF MARKETING AND ADVERTISING COMPANIES FOR MONETARY COMPENSATION.WE HAVE NOT BEEN COMPENSATED TO COVER KSPN AND DO NOT OWN ANY SHARES OF THE COMPANY. NEVER INVEST IN ANY STOCK FEATURED ON OUR SITE OR EMAILS UNLESS YOU CAN AFFORD TO LOSE YOUR ENTIRE INVESTMENT. THE DISCLAIMER IS TO BE READ AND FULLY UNDERSTOOD BEFORE USING OUR SERVICES, JOINING OUR SITE OR OUR EMAIL/BLOG LIST AS WELL AS ANY SOCIAL NETWORKING PLATFORMS WE MAY USE.PLEASE NOTE WELL: DEDICATED INVESTORS LLC AND ITS EMPLOYEES ARE NOT A REGISTERED INVESTMENT ADVISOR, BROKER DEALER OR A MEMBER OF ANY ASSOCIATION FOR OTHER RESEARCH PROVIDERS IN ANY JURISDICTION WHATSOEVER.RELEASE OF LIABILITY: THROUGH USE OF THIS WEBSITE VIEWING OR USING YOU AGREE TO HOLD DEDICATED INVESTORS LLC, ITS OPERATORS OWNERS AND EMPLOYEES HARMLESS AND TO COMPLETELY RELEASE THEM FROM ANY AND ALL LIABILITY DUE TO ANY AND ALL LOSS (MONETARY OR OTHERWISE), DAMAGE (MONETARY OR OTHERWISE), OR INJURY (MONETARY OR OTHERWISE) THAT YOU MAY INCUR. THE INFORMATION CONTAINED HEREIN IS BASED ON SOURCES WHICH WE BELIEVE TO BE RELIABLE BUT IS NOT GUARANTEED BY US AS BEING ACCURATE AND DOES NOT PURPORT TO BE A COMPLETE STATEMENT OR SUMMARY OF THE AVAILABLE DATA. 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READERS ARE ADVISED TO REVIEW SEC PERIODIC REPORTS: FORMS 10-Q, 10K, FORM 8-K, INSIDER REPORTS, FORMS 3, 4, 5 SCHEDULE 13D.DEDICATED INVESTORS, LLC IS COMPLIANT WITH THE CAN SPAM ACT OF 2003. DEDICATED INVESTORS LLC DOES NOT OFFER SUCH ADVICE OR ANALYSIS, AND DEDICATED INVESTORS LLC FURTHER URGES YOU TO CONSULT YOUR OWN INDEPENDENT TAX, BUSINESS, FINANCIAL AND INVESTMENT ADVISORS. INVESTING IN MICRO-CAP AND GROWTH SECURITIES IS HIGHLY SPECULATIVE AND CARRIES AND EXTREMELY HIGH DEGREE OF RISK. IT IS POSSIBLE THAT AN INVESTORS INVESTMENT MAY BE LOST OR IMPAIRED DUE TO THE SPECULATIVE NATURE OF THE COMPANIES PROFILED.THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995 PROVIDES INVESTORS A SAFE HARBOR IN REGARD TO FORWARD-LOOKING STATEMENTS. ANY STATEMENTS THAT EXPRESS OR INVOLVE DISCUSSIONS WITH RESPECT TO PREDICTIONS, EXPECTATIONS, BELIEFS, PLANS, PROJECTIONS, OBJECTIVES, GOALS, ASSUMPTIONS OR FUTURE EVENTS OR PERFORMANCE ARE NOT STATEMENTS OF HISTORICAL FACT MAY BE FORWARD LOOKING STATEMENTS. FORWARD LOOKING STATEMENTS ARE BASED ON EXPECTATIONS, ESTIMATES, AND PROJECTIONS AT THE TIME THE STATEMENTS ARE MADE THAT INVOLVE A NUMBER OF RISKS AND UNCERTAINTIES WHICH COULD CAUSE ACTUAL RESULTS OR EVENTS TO DIFFER MATERIALLY FROM THOSE PRESENTLY ANTICIPATED. FORWARD LOOKING STATEMENTS IN THIS ACTION MAY BE IDENTIFIED THROUGH USE OF WORDS SUCH AS PROJECTS, FORESEE, EXPECTS, WILL, ANTICIPATES, ESTIMATES, BELIEVES, UNDERSTANDS, OR THAT BY STATEMENTS INDICATING CERTAIN ACTIONS & QUOTE; MAY, COULD, OR MIGHT OCCUR. UNDERSTAND THERE IS NO GUARANTEE PAST PERFORMANCE WILL BE INDICATIVE OF FUTURE RESULTS. IN PREPARING THIS PUBLICATION, DEDICATED INVESTORS LLC HAS RELIED UPON INFORMATION SUPPLIED BY ITS CUSTOMERS, PUBLICLY AVAILABLE INFORMATION AND PRESS RELEASES WHICH IT BELIEVES TO BE RELIABLE; HOWEVER, SUCH RELIABILITY CANNOT BE GUARANTEED. INVESTORS SHOULD NOT RELY ON THE INFORMATION CONTAINED IN THIS WEBSITE. RATHER, INVESTORS SHOULD USE THE INFORMATION CONTAINED IN THIS WEBSITE AS A STARTING POINT FOR DOING ADDITIONAL INDEPENDENT RESEARCH ON THE FEATURED COMPANIES. DEDICATED INVESTORS LLC HAS NOT BEEN COMPENSATED FOR THIS EMAIL. THE ADVERTISEMENTS IN THIS WEBSITE ARE BELIEVED TO BE RELIABLE, HOWEVER, DEDICATED INVESTORS LLC AND ITS OWNERS, AFFILIATES, SUBSIDIARIES, OFFICERS, DIRECTORS, REPRESENTATIVES AND AGENTS DISCLAIM ANY LIABILITY AS TO THE COMPLETENESS OR ACCURACY OF THE INFORMATION CONTAINED IN ANY ADVERTISEMENT AND FOR ANY OMISSIONS OF MATERIALS FACTS FROM SUCH ADVERTISEMENT. DEDICATED INVESTORS LLC IS NOT RESPONSIBLE FOR ANY CLAIMS MADE BY THE COMPANIES ADVERTISED HEREIN, NOR IS DEDICATED INVESTORS LLC RESPONSIBLE FOR ANY OTHER PROMOTIONAL FIRM, ITS PROGRAM OR ITS STRUCTURE. DEDICATED INVESTORS LLC IS NOT AFFILIATED WITH ANY EXCHANGE, ELECTRONIC QUOTATION SYSTEM, THE SECURITIES EXCHANGE COMMISSION OR FINRA.
We have Nasdaq profile that we want to bring to your attention for tomorrows session.
If you have been a member for a while then you will certainly remember this one.
We profiled it back in early December when it was sitting under .50.
By Mid February this one tapped 1.46 for a 200% move in just 2 months.
Pull up BSGM immediately for Tuesday’s session.
BSGM is an advanced digital signal processing technology company bringing never-before-seen insights to the treatment of cardiovascular arrhythmias. The Company operates within the rapidly growing electrophysiology (EP) marketplace – a market projected to reach $16B by 2028 with a 11.2% growth rate.
BioSig’s first product, the PURE EPTM System, is an FDA 510(k) cleared non-invasive class II device, that provides superior, real-time signal visualization allowing physicians to perform insight-based, highly targeted cardiac ablation procedures with increased procedural efficiency and efficacy.
Having recently commenced PURE EPTM’s national commerical launch, the technology is already an integral part of many well-respected healthcare systems, including Mayo Clinic, Texas Cardiac Arrhythmia Institute, Cleveland Clinic, and Kansas City Heart Rhythm Institute. To date, physicians have completed approximately 3000 patient cases with the PURE EPTM System.
BIOSIG ISSUES SHAREHOLDER UPDATE TO HIGHLIGHT RECENT ACHIEVEMENTS AND ONGOING DEVELOPMENTS
Westport, CT, Jan. 19, 2023 (GLOBE NEWSWIRE) —
To date, the Company’s FDA 510(k)-cleared PURE EP™ System has been used in approximately 3,000 patient cases across the United States
The Company has built a robust pipeline of commercial sale prospects and expects multiple closings in first half of 2023
New supporting clinical data to be published
BioSig Technologies, Inc. (NASDAQ: BSGM) (“BioSig” or the “Company”) an advanced digital signal processing technology company delivering unprecedented accuracy and precision to intracardiac signal visualization with its proprietary PURE EP™ System, today issued an update to shareholders highlighting recent milestones and ongoing company developments.
Dear Shareholders:
January 2023 marks the one-year anniversary of redefining our product development and commercial strategies led by John Sieckhaus and Gray Fleming, respectively. During this time, we have built new sales and clinical teams, introduced new corporate and product branding, launched potentially game-changing software, secured numerous evaluations, established new research protocols, signed purchase agreements, and created a promising revenue pipeline. These are milestones never seen before at BioSig and we believe there are many more exciting ones ahead.
While we are proud of the commercial progress BioSig has made over the past twelve months, 2022 proved to be a challenging year for the economy, and especially for Life Sciences companies like ours. This was reflected in our valuation. History shows us that innovative companies and technologies can prevail following economic downturns. The sharp market declines in 2000-2002 and 2008-2009 were followed by economic recoveries where new leaders emerged. We are confident that BioSig will be one of those emerging leaders based on the exciting commercial, technology and corporate activities underway in 2023.
At BioSig, we understand the importance of personalized patient care and the economic squeeze of making every clinical decision count. We believe that maintaining the integrity of intracardiac signals with precision and clarity—without driving up procedural costs—has never been more pertinent. Innovative technology will be critical for healthcare organizations in the year ahead and we believe BioSig’s technology is very attractive.
Recent Milestones
Despite the difficult operating environment, there were several positives that came out of the year for the Company, our customers, and our shareholders. Most recently, we successfully raised approximately $3.8 mm in private placements of common stock and warrants at what we believe were relatively attractive terms. We will continue to try to find shareholder-friendly ways to fund the Company as we work to grow revenue and expand our value proposition through the ongoing development of our technology. We also received a letter from Nasdaq notifying us that the Company has been granted an additional 180-day period, or until May 22, 2023, to regain compliance with the Stockholders’ Equity Requirement. Management believes that this is sufficient time to regain compliance.
Below is a list of examples that we believe demonstrate BioSig’s unique position within the Medtech industry and the growing interest in our disruptive technology, the PURE EP™ System.
On January 10, 2023, we announced that Bellin Health entered into an agreement to acquire a PURE EP™ System. Through a formal evaluation, Bellin reported that clear cardiac signals positively impacted procedural efficiency resulting in cost savings per procedure.
Over 3,000 procedures have been performed using the PURE EP™ System with more than 80 physicians at 21 hospitals across the United States.
The PURE EP™ System was featured in an abstract presentation at the 15th Asia Pacific Heart Rhythm Society (APHRS) Scientific Session in Singapore. Results from the randomized study revealed the PURE EP™ System’s potential to promote shorter procedural times and higher cost savings during catheter ablation procedures.
BioSig’s PURE EP™ System was highlighted in a peer-reviewed case report by the Journal of Atrial Fibrillation & Electrophysiology (JAFIB-EP). This clinical abstract detailed the value of PURE EP™ and its groundbreaking High Frequency Algorithm (HFA) during pulmonary vein isolation.
A Master Research Agreement was signed with the Cleveland Clinic to explore expanded applications for its digital signal processing technology.
A purchase agreement was signed with San Antonio Methodist Hospital.
Launched PURE EP™ software Version 6 with ACCUVIZ™ Module highlighting the proprietary High Frequency Algorithm (HFA), a novel feature that identifies the key frequency components of cardiac data that can be difficult to identify within the traditional waveform presentation.
Cleveland Clinic, a leading Medical Center of Excellence, agreed to evaluate the PURE EP System, and a short time later requested a second system for evaluation.
A purchase agreement was signed with Kansas City Heart Rhythm Institute at Overland Park Regional Medical Center.
The PURE EP™ System was featured at numerous conferences including Kansas City Heart Rhythm Symposium 2022, the 17th Edition Venice Arrhythmias 2022 Congress, and EPLive 2022.
Final Thoughts
Although 2022 was a difficult, year, we have the fortitude and laser focus to build on the progress we have made and are energized for what the new year brings us. We will continue to advance our commercialization strategy and look to add more hospitals and centers of excellence to our portfolio of PURE EP™ adopters. We are fortunate to operate in a growing sector as the global EP market is expected to reach $16 billion by 2028, an estimated 11.2% compound annual growth rate. With the number of annual catheter ablation procedures expected to grow, we believe that our PURE EP™ technology is well-positioned to set a new standard in intracardiac visualization.
As physician advocates, we are dedicated to developing technology that provides greater clarity and opens doors to ingenious treatment solutions for the most challenging arrhythmias. Collaborating with equal parts respect and humility, we are advancing science and technology, furthering the field of electrophysiology, and helping to solve healthcare’s greatest challenges.
Thank you for your patience, confidence, and trust in BioSig.
Kenneth L. Londoner, Chairman, and CEO of BioSig Technologies, Inc.
________
ACHIEVEMENTS
Announced Evaluation Agreement with Cleveland Clinic
Surpassed 3000 procedures
Announced 49 allowed/ issued design and utility patents
Appointed John Sieckhaus as Chief Operating Officer
Appointed Gray Fleming as Chief Commercial Officer
Clinical data acquired by PURE EPTM published in the Journal of Cardiovascular Electrophysiology
Selected Plexus Corp. as its manufacturing partner
Announced medical device industry leader to its board of directors
Unblinding of clinical data from PURE EPTM 2.0 Study showed signal superiority to standard of care
Achieved first commercial sales at TCAI and various Mayo Clinic sites
INVESTMENT HIGHLIGHTS
• World class commercial team • Achieved first revenues • Conducted First Clinical Trial with PURE EPTM System • Significant Insider Ownership • 10-year Strategic Collaboration with Mayo Clinic • IP Strategy Led by Sherpa Technology Group and Sterne Kessler Goldstein & Fox. — 49 allowed/issued design and utility patents • FDA clearance achieved • Proven Management Team and Board of Directors • Global and Growing Addressable Market • Operates Within Rapidly Emerging Field of Bioelectronic Medicine • High-Growth Sector Earns Innovation Premium, Aggressive M&A
BIOSIG EXECUTES AGREEMENT WITH BELLIN HEALTH FOR THE ACQUISITION OF ITS PURE EP™ TECHNOLOGY
Leading Midwest healthcare system reports significant cost savings and noise reduction following evaluation of the PURE EP™ System
Medical center signs agreement to acquire the Company’s digital signal processing technology for arrhythmia care
BioSig Technologies, Inc. (NASDAQ: BSGM) (“BioSig” or the “Company”) an advanced digital signal processing technology company delivering unprecedented accuracy and precision to intracardiac signal visualization with its proprietary PURE EP™ System, today announced that Bellin Health System in Green Bay, Wisconsin has signed an agreement to acquire the Company’s PURE EP™ System.
The agreement follows a 60-day formal evaluation of the PURE EP™ System at Bellin Health. The hospital reported that the PURE EP™ demonstrated a significant cost savings per case as well as a substantial reduction in noise and signal interference compared to the use of conventional systems only.
The agreement grants Bellin Health full autonomy with respect to its operation of the PURE EP™ System, and BioSig will not be required to provide an on-site clinical account manager following the new system install.
The PURE EP™ System is a combination of hardware and software that enables the real-time acquisition of raw signal data—absent of unnecessary noise or interference—allowing physicians to make informed clinical decisions based on clear and precise data. With the heightened visualization of active signals, the PURE EP™ System is facilitating personalized patient care and innovations in the field of electrophysiology.
“Bellin has observed, first-hand, that clear cardiac signals provide more information that can impact procedural efficiency without driving up procedural costs,” commented Gray Fleming, Chief Commercial Officer, BioSig Technologies. “The terms of this agreement represent a new milestone for the PURE EP™ System—expanding the accessibility and automaticity of our novel digital signal processing technology.”
Bellin Health recently announced plans to combine operations with Gundersen Health System, a physician-led, nonprofit, integrated healthcare network headquartered in La Crosse, Wisconsin. The hospital serves 22 counties in western Wisconsin, southeastern Minnesota, and northeast Iowa. The merger allows the health systems to offer access to more resources and a broader network of top-tier clinical services, shared provider expertise, state-of-the-art technology and digital healthcare tools that bring virtual care options into homes and workplaces.1
About Bellin Health Bellin Health’s Heart and Vascular Team brings more than 50 years of experience in all facets of cardiac care, making the medical center the most experienced program in the region. The physicians at Bellin are board-certified specialists with experience in all areas of cardiovascular care including echocardiography, nuclear cardiology, interventional cardiology, electrophysiology, and endovascular medicine. As the largest group of cardiovascular specialists in Green Bay, Bellin Health is renowned for its comprehensive cardiovascular care centers across the Midwest and its surrounding regions. (www.bellin.org).
Clinical data acquired by the PURE EP™ System in a multi-center study at Texas Cardiac Arrhythmia Institute at St. David’s Medical Center, Mayo Clinic Jacksonville and Massachusetts General Hospital was recently published in the Journal of Cardiovascular Electrophysiology and is available electronically with open access via the Wiley Online Library. I want to note that BSGM has a long-term relationship with the Mayo Clinic in the development of the PURE EP™ System.
NEUROCLEAR
NOVEL ENG PLATFORM TECHNOLOGY
Our technology aims to address technological deficiencies present in the current electroneurogram recording systems through high-speed recording of biomedical signals, the ability to preserve valuable clinical information and optimization of therapy delivery through closed feedback loop.
Our first product focuses on improving safety and efficacy of renal denervation procedures.
INTRODUCING N-SENSE
Multi-channel hardware designed to sense & stimulate nerves.
Simultaneous stimulation and measure for optimal closed loop feedback system.
Aid in targeting nerve location.
Algorithms tailored to specific applications.
Assess nerve for hyperactivity.
Catheter-agnostic interface.
PARTNERSHIPS
We have partnerships with some of the most distinguished organizations and experts in the fields of electrophysiology, intellectual property (IP) strategy, and technology development.
In 2017 we signed a ground-breaking 10-year strategic collaboration with experts at Mayo Clinic to both develop advanced clinical features of the PURE EP™ System and explore new disease areas and applications. We expect our collaboration to result in joint patent filings and licensing opportunities. Our research program with Mayo Clinic is run under the leadership of Samuel J. Asirvatham, M.D., Vice-Chair of Innovation and Medical Director, Electrophysiology Laboratory.
We have worked closely with leading patent experts to develop a robust IP strategy. Our IP strategic advisor – Sherpa Technology Group (STG) – is one of the best in the field, working at the intersection of business, technology, and intellectual property. Our patent attorneys, Sterne, Kessler, Goldstein & Fox, are equally distinguished and have been on the cutting edge of IP law for four decades.
We also have a technology development partnership with Plexus Corp. [Nasdaq: PLXS]. Their engineering and manufacturing capabilities and outstanding expertise in building complex medical devices make Plexus a foundational cornerstone to support BioSig’s growth objectives now and well into the future.
KEY GROWTH DRIVERS
1) Advanced Technology — The non-invasive PURE EP System is a computerized system intended for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording and storing of electrocardiographic and intracardiac signals for patients undergoing electrophysiology EP procedures in an EP laboratory under the supervision of licensed healthcare practitioners who are responsible for interpreting the data. The PURE EP System aims to minimize noise and artifacts, and acquire high- fidelity cardiac signals. Improving cardiac signals may potentially increase the diagnostic value of these signals, thereby possibly improving accuracy and efficiency of the EP studies and ablation procedures.
2) Market Opportunity — 2019 DRG Medtech 360 Report states the global EP device market is expected to exceed more than US $10.1 billion by 2024 and is growing at a compound annual growth rate (CAGR) of 11.3%. The Company also operates within the rapidly emerging field of bioelectronic medicine, estimated at $25.11 billion in 2020 with projected annual growth of 10.27%.
3) KOL Support — PURE EP has been used and valued by many of the industry’s leading electrophysiology physicians, including Dr. Andrea Natale of Texas Cardiac Arrhythmia Institute, and Dr. G. Joseph Gallinghouse. The Company achieved proof of concept validation through UCLA, and has performed numerous pre-clinical studies at Mayo Clinic, MN under the leadership of Samuel J. Asirvatham, M.D., Mayo Clinic’s Vice-Chair of Innovation and Medical Director, Electrophysiology Laboratory.
BIOELECTRONIC MEDICINE
Bioelectronic medicine is a rapidly growing field of healthcare that explores how targeted electrical signals can harness the body’s natural mechanisms to diagnose and treat a range of diseases. The field represents not just a narrow category of medical devices, but an entire approach to detecting and treating disease – using electrical pulses and the body’s own mechanisms as an adjunct or alternative to drugs and medical procedures.
Bioelectronic medicine applications aim to deliver treatment breakthroughs for many diseases that currently have a high level of unmet need. Researchers and innovators are exploring the field’s applications across various disease areas and disciplines, including neurology, auto-immune diseases, diabetes, arthritis, hypertension, pain management, cancer, and others. This wide range of applications sets bioelectronic medicine apart and indicates its immense potential.
We know we’re not alone in embracing a future with bioelectronic medicine. The field is making rapid strides, but this is just the beginning of what’s possible. That’s why we helped create the Alliance for Advancing Bioelectronic Medicine, an independent network of professionals dedicated to innovation at the intersection of healthcare and technology. We strive to develop this community with a common goal of realizing the field’s full potential.
Bioelectronic medicine is already a diverse, $20 billion market. It includes both familiar devices, such as pacemakers, as well as emerging technologies, such as vagus nerve stimulators and implantable neurostimulators. These exciting new segments are proliferating and attracting interest and investment from major players in technology and healthcare, such as Verily Life Sciences, Medtronic, and Johnson & Johnson.
As the field continues to develop, we believe our unique technology can play a critical enabling role. By providing more precise biomedical signals, our advanced signal processing capabilities can help clinicians better understand and change patterns to treat, or even prevent diseases.
BIOSIG AWARDED US PATENT CLAIMS FOR ITS UNIVERSAL NOTCH FILTER TECHNOLOGY
Patent can remove any fixed frequency interfering with original signal of interest preserving critical intracardiac data
BioSig now has 56 worldwide fundamental granted/allowed patents in the field of digital signal processing
BioSig Technologies, Inc. (NASDAQ: BSGM) (“BioSig” or the “Company”) an advanced digital signal processing technology company delivering unprecedented accuracy and precision to intracardiac signal visualization with its proprietary PURE EP™ System, today announced that the US Patent Office has issued a utility patent covering its PURE EP™ universal notch filtering technology.
Patent No. 11,569,853 was issued on January 31, 2023 and is entitled “Universal Notch Filter ” and is based on U.S. Application No. 17/591,008 with a priority date of November 8, 2019. The patent describes and claims systems, methods, and computer program product embodiments of the PURE EP™ System for removing any fixed frequency interfering signal from an input signal without introducing artifacts that are not part of the original signal of interest.
“This latest patent award further demonstrates our commitment to developing technology that protects elaborate cardiac signals and furthers the field of electrophysiology,” said Ken Londoner, Chairman, CEO and Founder of BioSig Technologies, Inc. “PURE EP™ revitalizes the value of the EGM to help EP’s perform insight-based, highly targeted ablation procedures for even the most complex arrhythmias.”
BioSig now has 56 worldwide fundamental granted/allowed, 11 pending U.S. patent applications, and seven European/PCT applications covering its advanced signal processing technology. The company also has 13 pending patent applications in Asia including China, Korea, Japan and Taiwan.
Founder, Chief Executive Officer, Chairman, and Director
Mr. Londoner is a capital markets and capital architecture expert and a senior life science executive. Having started his career as a research analyst for J. & W. Seligman & Co., Inc., a leading institutional money management firm in New York City, NY, he quickly found himself at the forefront of the biotech industry in the early 1990s, leading him to manage $3.5 billion in mutual and pension funds and international assets.
His passion for medical innovation led him to co-found, govern and bring to the public market several life science companies, including BioSig Technologies, Inc. [NASDAQ: BSGM]. Working in close collaboration with key opinion leaders in electrophysiology, BioSig aims to improve the outcomes of cardiac ablations for the treatment of arrhythmias through novel technological solutions developed by the company and further apply its core competency in advanced biomedical signal processing and analysis to other areas of medicine.
His prior experience in recognizing the early potential of biotech led Londoner to for the Alliance for Advancing Bioelectronic Medicine, an independent non-profit network of professionals dedicated to innovation at the intersection of healthcare and technology. The Alliance aims to increase awareness of bioelectronic medicine and build a platform for collaboration among stakeholders. Over the last decade, Londoner formed top-level relationships with several medical centers of excellence such as Mayo Clinic, NYU Langone Hospital, and UCLA, as well as other stakeholders, including investment communities, intellectual property experts, and supply chain partners.
Mr. Londoner earned his BA in Economics from Lafayette College in 1989, and his Master of Business Administration in Management and Finance from New York University in 1994. Between 1999-2002, he served as an adjunct professor at the Columbia Business School. Additionally, in 2015, Mr. Londoner founded the Immersive Internship Program at Lafayette College.
STEVE BUHALY
Chief Financial Officer
Mr. Buhaly has over 15 years of CFO experience at three public U.S. companies. In 2007, he served as CFO to TriQuint Semiconductor who merged with RF Micro Devices, Inc. in a $4 billion merger agreement to form Qorvo in 2015. A world leader in innovative RF and power technologies, Qorvo grew into an $11 billion market capitalization during Mr. Buhaly’s tenure. Prior to TriQuint, Mr. Buhaly served as CFO of Longview Fibre where he played a key role in executing the $2.3 billion sale of the company. Earlier in his career, he held both chief operating officer and chief financial officer roles with electronic display company, Planar Systems.
Throughout his career, Mr. Buhaly has developed a strong cross-functional background in corporate finance, accounting, tax, IT, law, and investor relations. Having co-led strategic transactions resulting in over $2 billion in M&A transactions, he has helped companies raise $1 billion in the debt markets and was recognized for his leadership during TriQuint’s massive growth trajectory. Since 2018, Mr. Buhaly has served as an advisor to multiple early-stage and small businesses and currently consults for cancer treatment innovator, UbiVac.
Mr. Buhaly holds an MBA from the University of Washington.
GRAY FLEMING
Chief Commercial Officer
Mr. Fleming brings to the Company over 20 years in the healthcare industry, including 17 years at Abbott Laboratories and St. Jude Medical. During his tenure with Abbott, Mr. Fleming held several commercial leadership positions, including Vice President of Cardiac Sales, when he led sales and customer relationship management activities in some of the most significant strategic areas of focus. Mr. Fleming’s experience in delivering high-performing sales management initiatives led to substantial revenue growth with several key accomplishments, including the successful contracting of multiple leading IDN and GPO organizations. These initiatives resulted in some of the largest market share gains in the company’s history while also delivering substantial overhauls of historically underperforming regions throughout the Central Time Zone. Most recently, Mr. Fleming held the position of Chief Commercial Officer at Carecubes, a company created to provide a temporary and scalable negative pressure isolation technology solution based upon original joint request from the Defense Advanced Research Projects Agency (DARPA) and Centers for Disease Control and Prevention (CDC). Mr. Fleming holds a Bachelor of Business Administration degree with a Major in Marketing from Stephen F. Austin State University in Texas and a certificate in Leadership in Excellence and Development (LEAD) Program from the University of Texas.
JOHN SIECKHAUS
Chief Operating Officer
Mr. Sieckhaus brings to the Company 30 years in the healthcare industry, including 21 years at St. Jude Medical and Abbott Laboratories [NYSE: ABT]. During his tenure with St. Jude Medical, Mr. Sieckhaus held commercial leadership positions of rising responsibility, including U.S. National Sales Leader, Senior Vice President & General Manager when he led sales and customer relationship management activities in the United States across all cardiovascular product lines. Mr. Sieckhaus’s experience in building and leading high-performance teams, in addition to integrating multiple new and novel technologies and introducing them commercially, led to significant revenue growth for St. Jude Medical over his career. Most recently, Mr. Sieckhaus held the position of Vice President – Field Clinical Affairs for Abbott for the United States and CALA, where he created a world-class field clinical and monitoring team to support clinical trials across multiple business units within Abbott’s Cardiovascular portfolio. Mr. Sieckhaus holds a Bachelor of Science degree in Biomedical Engineering from Johns Hopkins University.
BRENDA CASTRODAD
Vice President, Human Resources
A seasoned executive, Ms. Castrodad brings a wealth of experience in leading organizational development in start-ups and Fortune 500 companies within the life sciences sector. Most recently, Ms. Castrodad led the HR department at TissueTech, Inc., a Miami, FL-based biotech leader in regenerative amniotic tissue-based products, where she was responsible for transformation and automation of the company’s HR practices, talent planning, and team building. Prior to TissueTech, Inc., Ms. Castrodad spent six years at HeartWare, Inc., a heart failure medtech company acquired by Medtronic [NYSE:MDT] in 2016 for $1.1 billion. By optimizing the internal talent acquisition function and aligning business practices, Ms. Castrodad helped grow the organization from approx. 80 to 500+ staff which achieved approx. $250 million in revenues before the acquisition. Earlier in her career, Ms. Castrodad spent 16 years at Schering-Plough Corp, a pharmaceutical company acquired in 2009 for $41.1 billion by Merck & Co. [NYSE:MRK]. Ms. Castrodad holds a Master’s Degree in Public Administration and a Bachelor’s Degree in Social Sciences – Human Welfare from the University of Puerto Rico and a Labor Relations Certificate from the University of Michigan.
ANDREW BALLOU
Vice President, Investor Relations
Mr. Ballou brings to BioSig over 25 years of experience in capital markets, including institutional equity sales and research analysis. Most recently, Mr. Ballou served as Managing Director, Head of Institutional Equity Sales at Janney Montgomery Scott LLC., a role in which he oversaw key accounts, including large multi-manager hedge funds, mutual funds and dedicated sector funds. Prior to that role Mr. Ballou managed selected key account coverage at RBC Capital Markets, including Millennium Partners, Soros Fund Management, SIR Capital, Columbia Threadneedle, Two Sigma Investments and Times Square Capital Management. During the course of his career Mr. Ballou analyzed various private and public companies in healthcare, media and retail sectors. Mr. Ballou graduated from Hampden-Sydney College, Virginia, with a Bachelor of Arts in English.
KATIE FRESHWATER
Vice President, Marketing
Ms. Freshwater brings over 20 years of sales and marketing experience in healthcare and technology, including senior positions at several leading medtech companies such as Cardinal Health, Medtronic, and Kimberly-Clark Healthcare. During her tenure at Cardinal Health, Ms. Freshwater served as Senior Director of Digital Marketing, e-Commerce, and Brand where she oversaw the development of marketing tech strategy and a team of 20+ digital marketers, content creators, and paid media strategists. More recently, Ms. Freshwater founded FRESH20 Consulting, where she has served as Senior Consultant providing independent marketing services and modern sales solutions for businesses ranging from early state startup-ups to large corporations.
At BioSig, Ms. Freshwater will work directly with all facets of the company on development, implementation, and management of the Company’s strategic and tactical marketing activities. She is responsible for developing and delivering a fully integrated marketing strategy, to include MarTech and MarCom functions. In addition, Mrs. Freshwater will support the Company’s brand visibility across print and digital media through best-in-class tailored approaches that drive sustainable growth for the business.
Ms. Freshwater holds a bachelor’s degree in business administration from the University of Denver and an MBA from Baylor University.
ZACHARY KOCH, CCDS, CEPS
Principal Advisor, Product Development
Zachary Koch brings over 20 years of experience in clinical strategy and sales in electrophysiology and cardiovascular devices. Mr. Koch joins BioSig’s leadership following a 16-year tenure at Abbott and St. Jude Medical, where he held numerous positions across the company’s clinical, sales, training, and commercial teams. Mr. Koch has personally supported over 5000 cardiac mapping procedures, and has created and lead several advanced training and education initiatives for St Jude Medical and Abbott EP. More recently, within his role as Manager of Strategic EP Clinical Development, Mr. Koch successfully founded and launched the Key Accounts Organization for Abbott EP and led the business and clinical strategy across nine National Key Accounts. These efforts generated a 20% increase in EP case volume and revenue for the company. He also founded the AAA advanced training program that led to a significant improvement of clinical support with the Key Accounts Organization. He has been recognized for his sales and business delivery as a three-time recipient of Abbott’s Field Service Award, an honor bestowed upon the top clinical specialists in the US sales division. He is also a certified electrophysiology and cardiac device specialist, a distinguished honor apportioned by the International Board of Heart Rhythm Examiners.
Mr. Koch served as a Hospital Corpsman in the United States Navy. He provided infantry medical support for the Second Marine Division and the Executive Medical Team at the National Naval Medical Center in Washington DC. He holds a degree in Cardiovascular Technology from the Naval School of Health Sciences, where he graduated with honors and distinction.
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We have another exciting profile for tomorrow’s session that we want you to research immediately.
Pull up LSDI right away and put it on your screen.
You can see that over the past few sessions it has leveled off and found support in this range.
Over the past few sessions you can see this one two out of the past 3 sessions we have seen a strong reversal and interest is picking up tremendously.
We think that this is a great time to research this one while it is sitting right here at these levels based on the discount from just a few short weeks ago.
I don’t have a crystal ball but I have certainly seen several recent IPO’s sell off immediately after their listing and as soon as they find support and start releasing news that the street is paying attention to it starts to stabilize. Last Friday we saw some strong news released and the market reacted. Yesterday was more of the same with this one and it jumped up over 20%.
Lucy Scientific Discovery Inc. [NASDAQ:LSDI] an early-stage psychedelics manufacturing company that is focused on becoming the premier research, development, and manufacturing organization for the emerging psychedelics-based medicines industry. Lucy maintains a Controlled Drugs and Substances Dealer’s License under Part J of the Food and Drug Regulations promulgated under the Food and Drugs Act (Canada), more commonly known as a Dealer’s License, that was issued to Lucy by Health Canada’s Office of Controlled Substances. This Dealer’s License authorizes the Company to develop, sell, deliver, and manufacture (through extraction or synthesis) certain pharmaceutical-grade active pharmaceutical ingredients, or APIs, used in controlled substances and their raw material precursors.
In light of the growing interest in the use of psilocybin, MDMA and other psychedelics in psychotherapy, Health Canada issued a notice spelling out how licensed providers can obtain the drugs through the agency’s special access program on a case-by-case basis.
“The evidence is emerging that psychedelic-assisted therapy holds a lot of promise in treating mental health issues like posttraumatic stress disorder and treatment-resistant depression,” said Mike Ellis, Alberta’s associate minister of mental health and addictions at the time.
The exact mechanisms at work are still unclear, but it’s thought that psychedelics promote neural plasticity in key circuits relevant to brain health, including those involved in mood, cognition, perception, and regulating stress responses.
WESANA HEALTH ANNOUNCES SALE OF SANA-13 ASSETS TO LUCY SCIENTIFIC DISCOVERY
CHICAGO and TORONTO, March 21, 2023 (GLOBE NEWSWIRE) — Wesana Health Holdings Inc. (“Wesana” or the “Company”) (CSE: WESA; OTCQB: WSNAF), a data-driven life sciences company, today announced that the Company has entered into a definitive asset purchase agreement dated March 20 2023 (the “Asset Purchase Agreement”) with Lucy Scientific Discovery Inc. (“Lucy”) (NASDAQ:LSDI) for the sale by Wesana Health Inc. (“WHI”), a subsidiary of the Company, of its SANA-013 intellectual property and related assets for consideration of 1,000,000 common shares of Lucy (the “Share Consideration”) and US$570,000 in cash (the “Cash Consideration”).
Transaction Highlights:
The Transaction (as defined below) provides an opportunity for the continued development of SANA-013 through the next phases of the US FDA regulatory process and for the Company to have economic exposure to any positive advancements in any such future research and development efforts by Lucy.
The Company will also have economic exposure to the broader Lucy asset portfolio and pipeline, including a Canadian Licensed Dealer conducting research on various compounds.
The Transaction is expected to close in Q2 2023, subject to and following the satisfaction (or waiver as permitted) of the conditions precedent to the Transaction.
“We have worked diligently over the previous two years to develop novel therapies for the treatment of major depressive disorder and have made some significant advances in our drug development program. Broader challenges in the macro-environment led us to consider strategic options, and we believe there is significant value held in continuing development of SANA-013,” commented Daniel Carcillo, Chief Executive Officer and Chairman of the Board.
Chris McElvany, Chief Executive Officer of Lucy, said, “expanding our footprint with the SANA-013 drug development program is a logical next step for Lucy, which should also drive growth in Lucy’s manufacturing business.”
Transaction Details:
Pursuant to the Asset Purchase Agreement, Lucy, an arms-length party to the Company, has agreed to acquire WHI’s SANA-013 intellectual property and related assets for aggregate consideration comprised of the Share Consideration and the Cash Consideration, as outlined in the Asset Purchase Agreement (the “Transaction”). US$300,000 of the Cash Consideration is anticipated to be paid to WHI shortly and the remainder of the Cash Consideration is required to be paid to WHI at closing. The proceeds from the Transaction are to be used by WHI for reasonable general corporate purposes which WHI deems necessary in its sole discretion to the development of SANA-013 and/or completion of the transaction contemplated by the Asset Purchase Agreement.
The Share Consideration shall be subject to a lock-up agreement (the “Lock-Up Agreement”) whereby (i) one-half of the Share Consideration will be released 9 months from initial trading date of LSDI shares, and (ii) one-half of the Share Consideration will be released 14 months from the initial trading date of LSDI shares.
The Share Consideration will be issued as “restricted securities” under the United States Securities Act of 1933, as amended, and may be publicly resold, subject to terms of the Lock-Up Agreement, in compliance with Rule 144 (“Rule 144”) thereunder. Lucy has granted the Company (i) demand registration rights in the event that Rule 144 is not available for the public resale of the Share Consideration, and (ii) piggy-back registration rights.
The Asset Purchase Agreement also contains customary non-solicitation covenants on the part of Wesana with respect to alternative transactions.
Among other conditions precedent, the consummation of the Transaction is subject to the approval of at least 66⅔% of the votes cast by Wesana shareholders voting in person or represented by proxy at a meeting of Wesana shareholders to be called by Wesana for purposes of considering the Transaction.
Certain shareholders of Wesana, representing all of the outstanding Wesana super voting shares, 23.1% of the outstanding Wesana proportionate subordinate voting shares and 14.7% of the outstanding Wesana subordinate voting shares, have entered into support agreements with Wesana, agreeing to support the Transaction and vote their Wesana shares in favour of the Transaction at the shareholders meeting to be called by Wesana for purposes of considering the Transaction.
Further details regarding the terms of the Asset Purchase Agreement and the Transaction are set out in the Asset Purchase Agreement, which will be filed by the Company under its profile on SEDAR at www.sedar.com. Additionally, further information regarding the Transaction, including the background thereto and the rationale for the recommendations made by the Special Committee and the Board, will be contained in the management information circular (the “Circular”) that the Company will prepare, file and mail to Wesana shareholders in connection with the meeting of Wesana shareholders to be called by Wesana for purposes of considering the Transaction and will file under the Company’s profile on SEDAR at www.sedar.com. All Wesana shareholders are urged to read the Circular as it will contain important information.
The Transaction is expected to close in the second quarter of 2023, subject to and following the satisfaction (or waiver as permitted) of the conditions precedent to the Transaction.
The Transaction will enable Lucy to provide continued capital investment to further the SANA-013 research and development required to meet the standards set by the United States Food and Drug Administration (“FDA”) to provide treatment against Major Depressive Disorder and other complementary orphan indications. The Share Consideration will enable the Company (through WHI) to have economic exposure to the future growth potential associated with SANA-013 and other initiatives underway or contemplated by Lucy.
Transition of Key Employees:
Subject to agreement on terms, it is anticipated that Wesana’s CEO and Chairman Daniel Carcillo will join Lucy’s team to integrate SANA-013 within Lucy.
Wesana also announces that as part of a planned transition, Mr. Zed Wang has resigned as the Company’s Chief Financial Officer and Corporate Secretary, and Mr. Winfield Ding has been appointed as the Company’s Chief Financial Officer and Corporate Secretary, effective immediately. Mr. Wang will be remain available to ensure a smooth transition.
Mr. Ding has been CFO and director for a number of public companies in Canada. He is a seasoned senior finance executive with over twenty years of finance and operations experience. A former audit manager and currently a self-practitioner, he has worked in audit, taxation and advisory roles across a wide range of industries with a focus on public issuers financial reporting and business advisory. Mr. Ding received his MBA from the Chinese University of Hong Kong.
“Winfield brings seasoned expertise in capital markets, strategic transactions, and public company compliance,” said Daniel Carcillo. He continued, “Zed’s departure comes with a successful transition of finance oversight to Winfield. We are extremely fortunate to have had Zed as part of the Wesana team from the beginning, and we wish him all the best as he goes on to pursue his other passions.”
Wesana Board Approval:
The Company’s board of directors (the “Board”), after receiving a recommendation from a special committee of the Board (the “Special Committee”), has determined (with Daniel Carcillo declaring an interest and abstaining) that the Transaction is in the best interests of the Company and that the consideration to be received by the Company pursuant to the Transaction is fair to the Company. Accordingly, the Board has approved the Asset Purchase Agreement and recommends that Wesana shareholders vote in favour of the Transaction.
Eight Capital has provided a fairness opinion to the Special Committee that, as of the date of such opinion and subject to the assumptions, limitations and qualifications on which such opinion is based, the consideration to be received by the Company pursuant to the Transaction is fair from a financial point of view to the Company.
LET’S TAKE A LOOK AT A TIMELINE OF SOME NOTEWORTHY EVENTS IN THE SECTOR:
2019: MAY 9TH
Denver, Colorado became the first city in the United States to decriminalize the cultivation, possession and use of psilocybin mushrooms.
2019: JUNE 5TH
Oakland California decriminalized the cultivation, possession and use of plants or fungi containing psychedelic compounds including DMT, ibogaine, mescaline and psilocybin.
2019: SEPTEMBER 4TH
Johns Hopkins launched the Center for Psychedelic and Consciousness Research. The center’s director, Roland Griffiths, said that researchers will focus on how psychedelics affect behavior, mood, cognition, brain function, learning, memory, and biological markers of health.
2019: NOVEMBER 22ND
The Food and Drug Administration granted Breakthrough Therapy designation to the Usona Institute for its psilocybin therapy for major depressive disorder. Usona’s phase 2 clinical trials will include 80 volunteers at seven sites around the U.S.
2020: OCTOBER 22ND
In Vancouver, Canada Numinus Wellness Inc. harvested the first legal flush of psilocybin mushrooms by a public company under its Health Canada-issued Controlled Drugs and Substances Dealer’s License.
2021: OCTOBER 18TH
Johns Hopkins Medicine was awarded a $3.9 million grant by the National Institutes of Health (NIH) for clinical research on psilocybin-assisted psychotherapy to treat tobacco addiction.
LUCY SCIENTIFIC TEAMS UP WITH PRAMANTHA GROUP TO SECURE KEY GOVERNMENT CONTRACTS AND GRANTS TO ENHANCE ITS MANUFACTURING CAPABILITIES
VICTORIA, British Columbia and VANCOUVER, British Columbia, March 17, 2023 (GLOBE NEWSWIRE) — Lucy Scientific Discovery Inc. (“Lucy” or “The Company”) [NASDAQ:LSDI], an early-stage psychedelics manufacturing company, announced today that it has partnered with Pramantha Group, a firm specializing in securing key government contracts and grants, to enhance its drug manufacturing capabilities and meet the growing demand for essential drugs and medical supplies.
The US government has been taking proactive measures to secure the domestic drug supply from international risks, given the severe shortages of key pharmaceutical drugs, nutraceuticals, and even baby formula in recent years. As part of this effort, multiple federal agencies across the US and Canada made funding available to support domestic drug manufacturing.
According to the United States International Trade Commission, the total value of pharmaceuticals imported into the United States was approximately $130 billion in 2020. The U.S. is one of the largest importers of pharmaceutical products in the world, and imports a wide variety of drugs including prescription drugs, over-the-counter medications, and active pharmaceutical ingredients (APIs) from countries such as China, India, and Ireland.
By leveraging Pramantha Group’s expertise in identifying and capturing strategic funding and contract opportunities, Lucy Scientific is well-positioned to compete for and secure key government contracts and grants. With access to these funds, Lucy Scientific will be able to expand its drug manufacturing capabilities and contribute to the country’s healthcare needs.
“Our partnership with Pramantha Group will help us navigate the complex landscape of government contracts and grants and identify the right opportunities to support our growth and contribute to the country’s healthcare needs,” said Lucy Scientific Discovery’s CEO Chris McElvany. “We are excited to work with Pramantha Group to enhance our drug manufacturing capabilities and play a key role in securing the domestic drug supply. Pramantha has a proven track record and a commitment to excellence that makes it an ideal partner for Lucy as we look to grow our operations.”
Pramantha Group is a firm that also specializes in securing very high-value target opportunities for companies across a wide range of industries. With a focus on federal and state National Security, Critical Infrastructure, and Economic Development programs, Pramantha Group provides its clients with the expertise and knowledge needed to navigate the complex landscape of government contracts and grants.
“Pramantha Group is excited to be partnering with Lucy Scientific,” said Phil Gothard, Principal of Pramantha Group. “With our extensive knowledge and understanding of government programs, we are confident that we can help Lucy Scientific identify and capture strategic funding and contract opportunities that are right for them.”
LUCY SCIENTIFIC DISCOVERY ANNOUNCES FIRST COMMERCIAL SALE OF PSILOCYBIN FOLLOWING INITIAL DELIVERY OF DMT AND 5-MEO-DMT TO HADASSAH BRAINLABS
VICTORIA, British Columbia, Feb. 27, 2023 (GLOBE NEWSWIRE) — Lucy Scientific Discovery Inc. (“Lucy” or the “Company”) [NASDAQ:LSDI], an early-stage manufacturing company that is focused on becoming the premier research, development, and manufacturing organization for traditionally stigmatized drugs including psychedelics announced today that it has agreed to its first commercial sale to the prestigious Hadassah BrainLabs – Center for Psychedelics Research, Hadassah Medical Center, Hebrew University, Jerusalem, Israel.
“This first commercial sale of psilocybin marks a key operational milestone for the company as we shift from pre revenue to revenue producing, and are excited about further opportunities ahead,” said Lucy’s CEO Chris McElvany. “This transaction establishes Lucy’s ability to supply the global psychedelic community with compounds and services. Not only will it strengthen our relationship with the researchers at Hadassah-Hebrew University Medical Center, whose research helps lay the academic foundations indicating the potential of psychedelics, it will lead to the improvement of lives of millions of people around the world.”
Hadassah BrainLabs was founded in 2013, as a National Knowledge Center for Research on Brain Disorders. Lucy has previously provided naturally-derived N.N-dimethyltryptamine (DMT) to the Brain Lab and Biological Psychiatry Department at Hadassah-Hebrew University. Data resulting from studies using the provided material is anticipated to be published in the near future.
“We extend our sincerest gratitude to LSDI for their efforts in our research endeavors,” said Dr. Bernard Lerer, Professor of Psychiatry and Director of Hadassah BrainLabs. “Their provision of a variety of psychedelic compounds has been instrumental in advancing our scientific understanding and opening new avenues for discovery. We are glad to have LSDI as a partner in our pursuit of knowledge.”
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API AND TARGET FORMULATION PRODUCTION
By leveraging various scalable production methods, they are uniquely positioned to effectively support current and future market needs at competitive prices.
Their use of efficient and strategic manufacturing practices will ensure a consistent and stable supply of the highest quality products from lab- to consumer-scale.
RESEARCH, DEVELOPMENT, AND COMMERCIALIZATION SUPPORT
They will work directly with researchers and finished product manufacturers in a controlled and collaborative environment to facilitate healthy market growth.
Their team aims to maximize your probability of success while minimizing the time and costs required to achieve your goals.
They are dedicated to the production of a variety of high-quality natural, synthetic, and biosynthetic products to meet the needs of the rapidly growing psychotropics-based medicines market.
VICTORIA, British Columbia and VANCOUVER, British Columbia, March 17, 2023 (GLOBE NEWSWIRE) — Lucy Scientific Discovery Inc. (“Lucy” or “The Company”) [NASDAQ:LSDI], an early-stage psychedelics manufacturing company, announced today that it has partnered with Pramantha Group, a firm specializing
VICTORIA, British Columbia, March 8, 2023 — Lucy Scientific Discovery Inc. (“Lucy” or the “Company”) [NASDAQ:LSDI], an early-stage psychedelics manufacturing company that is focused on becoming the premier research, development, and manufacturing organization for the emerging psychotropics-based
VICTORIA, British Columbia, Feb. 27, 2023 (GLOBE NEWSWIRE) — Lucy Scientific Discovery Inc. (“Lucy” or the “Company”) [NASDAQ:LSDI], an early-stage manufacturing company that is focused on becoming the premier research, development, and manufacturing organization for traditionally stigmatized
VICTORIA, British Columbia, Feb. 16, 2023 (GLOBE NEWSWIRE) — Lucy Scientific Discovery Inc. (“Lucy” or the “Company”) [NASDAQ:LSDI], an early-stage psychedelics manufacturing company that is focused on becoming the premier research, development, and manufacturing organization for the emerging
VICTORIA, British Columbia, Feb. 13, 2023 (GLOBE NEWSWIRE) — Lucy Scientific Discovery Inc. Nasdaq: LSDI , an early-stage psychotropics contract manufacturing company focused on becoming the premier contract research, development, and manufacturing organization for the emerging psychotropics-based
VICTORIA, British Columbia, Feb. 08, 2023 (GLOBE NEWSWIRE) — Lucy Scientific Discovery Inc. ( “the Company”), an early-stage psychotropics contract manufacturing company focused on becoming the premier contract research, development, and manufacturing organization for the emerging
MANAGEMENT
CHRIS MCELVANY
CEO & President
A pioneer of emerging psychotropic drug markets and co-founder of one of the world’s best selling cannabis products, O.penVAPE, Mr. McElvany leverages more than a decade of experience pushing the boundaries of regulated drug market innovation and successful business operation.
His strategic market positioning and the development and broad licensing of key enabling technologies drove his company, Organa Brands, to an eventual $200 million (USD) acquisition by Slang Worldwide (SLGWF).
development, biotechnology, agriculture, applied chemistry, and consumer product manufacturing industries.
DR. ASSAD J. KAZEMINY
Chief Scientific Officer
With a doctorate in pharmaceutical sciences, graduate studies in biochemistry, and a post-doctorate degree in pharmacology, Dr. Kazeminy has over 30 years of research and development experience in the biopharmaceutical industry, earning his place as a highly established authority of emerging biopharmaceutical advancement throughout the U.S. and Canada.
Having founded and served as CEO of Irvine Pharmaceutical Services Inc. and Avrio Biopharmaceutical LLC, Dr. Kazminy has served in a variety of positions over his impressive career, to include membership in the US Pharmacopeia Console of Experts and the UC Irvine Chief Executive Roundtable, to name a few.
Dr. Kazeminy is an expert in the facilitation of qualified trials and brings with him an undeniable track record of implementing best practices to ensure the validity and credibility of research outcomes. Dr. Kazeminy intends to leverage his vast network to enable the Lucy team to best support the psychotropic therapies industry as it continues to mature.
RICHARD NANULA
Executive Chairman
Highly experienced senior executive and former Executive Vice President and CFO at the Walt Disney Company, Mr. Nanula brings to bear a magnitude of leadership and strategy insights at the highest levels. Nanula’s various other executive roles include CEO of Broadband Sports, President and COO of Starwood Hotels, EVP of Finance and Strategy at Amgen, and Principal at Colony Capital.
In addition to Mr. Nanula’s executive leadership experience, he has also served in numerous director and advisory board positions throughout his professional tenure. Nanula is highly regarded as an investment advisor and is an esteemed graduate of Harvard Business School.
Sincerely,
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MAINZ BIOMED (NASDAQ: MYNZ) AIMS TO BECOME A LEADER IN THE MULTI-BILLION-DOLLAR COLORECTAL CANCER DIAGNOSTICS MARKET
CE-IVD CLEARED FLAGSHIP PRODUCT COLOALERT IS THE FIRST DNA-BASED SCREENING TEST FOR COLORECTAL CANCER IN EUROPE
MYNZ IS ALSO DEVELOPING PROPRIETARY GENETIC TESTING METHODS FOR PANCREATIC CANCER IN ADDITION TO COLOALERT, ALREADY ON THE MARKET IN EUROPE AND AWAITING APPROVAL IN THE USA.
Oncology is one of the biggest and fastest growing sectors. According to Fortune Business Insights, the oncology drug market size was valued at $141.33 billion in 2019 and it is expected to reach $394.24 billion in 2027 at an impressive CAGR of 11.6%.
The treatment for cancer is obviously lucrative… but so is its prevention. Scientists and doctors are constantly trying to develop better tools to identify cancer at earlier stages to save lives.
Since many types of cancer do not present early symptoms, at-home cancer screening kits check for markers that can indicate whether a person has cancer. Tests can detect chemicals that cancer cells produce even before symptoms appear.
This is putting the spotlight on an emerging biotech company that may have a game changing product for Colorectal cancer (CRC) at home testing.
An FDA decision is in the future for this game-changing test that even has the potential to compete with Cologuard wh0 is owned by Exact Sciences Corp, a company that did over $2 Bill in revenue last year with their various testing products.
Pull up MYNZ immediately.
Mainz Biomed develops market-ready molecular genetic diagnostic solutions for life-threatening conditions. The Company’s flagship product is ColoAlert, an accurate, non-invasive and easy-to-use, early-detection diagnostic test for colorectal cancer. ColoAlert is currently marketed across Europe and the United Arab Emirates with the intention of beginning its pivotal FDA clinical study in 2022 for US regulatory approval. Mainz Biomed’s product candidate portfolio also includes PancAlert, an early-stage pancreatic cancer screening test based on real-time Polymerase Chain Reaction-based (PCR) multiplex detection of molecular-genetic biomarkers in stool samples.
ColoAlert detects colorectal cancer (CRC) via a simple-to-administer test with a sensitivity and specificity nearly as high as the invasive colonoscopy (Dollinger MM et al., 2018). The test utilizes proprietary methods to analyze cell DNA for specific tumor markers combined with the fecal immunochemical test (FIT). It is designed to detect tumor DNA and CRC cases in their earliest stages. The product is CE-IVDR marked (complying with EU safety, health, and environmental requirements) and is commercially available in a selection of countries in the European Union and the United Arab Emirates. Mainz Biomed currently distributes ColoAlert through a number of clinical affiliates. Once approved in the US, the Company’s commercial strategy is to establish scalable distribution through a collaborative partner program with regional and national laboratory service providers across the country.
FILLING THE IMPORTANT GAP BETWEEN FIT AND COLONOSCOPY. COLOALERT IS THE ONLY CE-IVD DNA BASED TEST AVAILABLE IN EUROPE
Patients receive a simple kit that includes instructions, a stool collector and shipping instructions to return the kit through regular mail to their local lab for testing and results. IT’S THAT EASY.9
Colorectal cancer begins when cells in the intestine undergo genetic mutations. Tumor cells shed into the intestines. Stool samples can be examined for tumor DNA using PCR technology.
Polymerase chain reaction (PCR) is used to rapidly make millions to billions of copies of a specific DNA sample and only requires a very small sample of DNA to amplify it large enough for detailed study.
ColoAlert utilizes proprietary methods to analyse the cell DNA for specific tumor markers.
ColoAlert is designed to detect tumor DNA and detect 85% of colorectal cancer cases – often in the earliest stages of the disease.*
Ease-of-use drives ongoing patient adherence as the ColoAlert method requires very small samples compared to ColoGuard.
*Dollinger MM et al. (2018), ClinLab 64 (10), 1719-1730 and Gies et al. (2018). Gastroenterology 154 (1), 93-104.and Cooper GS et al. (2018). Dig Dis Sci. 63 (6), 1449-1453.* 18 study centres, 566 patients, 10/2018 and Amani et al. (2019). Clin. Lab. 65:1751-1754.
MAINZ BIOMED ANNOUNCES PARTNERSHIP WITH LABOR STABER TO EXPAND COLOALERT COMMERCIALIZATION IN GERMANY
Labor Staber to actively market and sell ColoAlert to its physician and patient network.
BERKELEY, Calif. and MAINZ, Germany, March 15, 2023 (GLOBE NEWSWIRE) — Mainz Biomed NV (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today a partnership with Dr Staber & Kollegen GmbH (Labor Staber) as part of its growing network of laboratories offering ColoAlert, its flagship product that is a highly efficacious and easy-to-use at-home screening test for colorectal cancer (CRC). For more than 35 years, Labor Staber has been providing physicians and hospitals with medical laboratory services at nine locations across Germany.
“At Mainz, we are on a mission to save lives through the early detection of CRC – the third most common cancer globally – by increasing consumer access to affordable and reliable CRC screening tests like ColoAlert,” said Guido Baechler, Chief Executive Officer of Mainz Biomed. “We continue to build mutually beneficial partnerships with diagnostic labs such as Labor Staber, as we have found putting our PCR testing kits in the hands of highly professional laboratory networks to be a much more effective business model than the traditional methodology of operating testing at a single facility.”
With more than 800 employees, including almost 100 medical specialists, biologists, chemists, and other academics from a wide variety of disciplines, Labor Staber offers a broad range of state-of-the-art medical diagnostics and services from a single source. Under the terms of this agreement, ColoAlert will now be marketed through Labor Staber’s extensive network of physicians and laboratories.
“Our labs combine regional character and collegiality with the organizational competence of a Germany-wide active laboratory group,” said Dr. Thomas Kellerer, Head of Molecular Biology at Labor Staber. “We look forward to working with Mainz as we share the same passion – to improve patients’ lives by using the most advanced analysis methods and equipment, as well as the highest quality standards, in all of our medical diagnostics.”
BERKELEY, US and MAINZ, Germany , Jan. 03, 2023 (GLOBE NEWSWIRE) — Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today a corporate summary for the fiscal year ended December 31, 2022.
Key Commercial, Operational and Product Development Highlights
Launched U.S.-based eAArly DETECT study by enrolling the first patient; study focused on the performance of Mainz Biomed’s mRNA biomarkers in identifying Advance Adenomas (AA), a type of pre-cancerous polyp often attributed to colorectal cancer (CRC); on track to report results in 1H 2023.
Initiated ReconAAsense, U.S. Pivotal Clinical Study with Company’s CRC screening test; anticipate commencing patient enrollment in mid-2023.
Continued executing differentiated business model of partnering with third-party laboratories for test kit processing versus the traditional methodology of operating a single facility.
Ramped up international commercial activities for ColoAlert, the Company’s highly efficacious and easy-to-use detection test for CRC, including five new lab partners in Germany and Italy.
Enhanced leadership team with appointments to Board of Directors and Company executives to lead commercial and product development groups, with former executives and senior management from Roche, Abbott, Luminex, and Qiagen; expanded Medical Advisory Board of global leaders in molecular diagnostic development.
Initiated and commenced patient enrollment in ColoFuture, a European study evaluating the integration of a portfolio of novel gene expression (mRNA) biomarkers into ColoAlert; potential to identify advanced adenomas, a type of pre-cancerous polyp often attributed to CRC; with results expected in 2023.
Achieved multiple preclinical milestones supporting the continued development of PancAlert, a potential first-in-class screening test for pancreatic cancer.
Acquired a portfolio of novel mRNA biomarkers to upgrade ColoAlert’s technical profile to achieve “gold standard” status for AA and CRC at-home testing.
Executed a USD 25.8 million (gross) public follow-on offering.
“The past year has proven to be an extraordinary period of growth as we strengthened every aspect of the Company while expanding our international commercial footprint and executing our product development programs,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed. “We head into 2023 with a great deal of momentum, and on behalf of the management team and Board of Directors, I wish to extend gratitude to our shareholders for their support as we continue our journey to become a leading provider of cancer-focused early detection and disease prevention molecular diagnostics.”
Commercial Update: Establishing an international market presence for ColoAlert
Throughout 2022, Mainz Biomed executed its differentiated commercial plan of partnering with third-party laboratories for test kit processing versus the traditional methodology of operating a single facility. Under the standard terms of all partnerships, Mainz Biomed is providing ColoAlert to the respective labs, including co-branding with key accounts, whereby each facility purchases Mainz Biomed’s customized polymerase chain reaction (PCR) assay kits on an on-demand basis and provides their respective network of physicians and patients with a comprehensive solution for advanced CRC detection.
Key partnership highlights included establishing high-profile commercial arrangements with leading laboratories such as Labor MVZ Dr. Stein + Kollegen, covering the North Rhine-Westphalia region of Germany, and Dante Labs in Italy and the United Arab Emirates. Labor MVZ Dr. Stein + Kollegen, commonly referred to as “Laboratory Mönchengladbach,” is one of the largest diagnostics laboratories in Germany, servicing over 2,500 physicians, processing over five million samples annually and screening approximately 1,000 patients per week specifically for CRC. Dante Labs is a global leader in genome sequencing with product development and a commercial franchise focused on providing preventive healthcare solutions to consumers and healthcare professionals. Inherent to Dante Lab’s business model is managing state-of-the-art genomic sequencing laboratories in multiple international regions and operating a robust e-commerce platform. With the addition of Laboratory Mönchengladbach and Dante Labs, Mainz Biomed now has five core partnerships, including GANZIMMUN Diagnostics AG, one of Europe’s leading laboratories for preventive and complementary medicine, which processes approximately 5,500 laboratory orders daily. Additional partnership agreements are currently being negotiated with other leading laboratories.
During the year, and specifically in the European region, Mainz Biomed enhanced its commercial strategy to include corporate health programs and direct-to-consumer sales capabilities.
ColoAlert Research and Development Summary: Achieved major clinical development milestones with the goal of upgrading ColoAlert to identify Advanced Adenomas
Over 2022, Mainz Biomed accomplished significant clinical development achievements for ColoAlert based on evaluating acquired mRNA biomarkers to potentially upgrade its technical profile to achieve “gold standard” status for CRC at-home testing. The Company received approval from an independent Institutional Review Board (IRB) and initiated ReconAAsense, a U.S. Pivotal Clinical Study, and commenced enrollment in ColoFuture and eAArly DETECT, an international multi-center clinical study (U.S. and Europe), assessing the potential to integrate mRNA biomarkers into ColoAlert. The mRNA biomarkers being evaluated were acquired from the Université de Sherbrooke in January 2022 and are the result of the institution’s pioneering work in the field, where researchers tested multiple novel transcriptional biomarkers using colorectal cancer and precancerous lesion samples. The results from these studies demonstrated that the mRNA targets chosen by Mainz Biomed provided a market-leading combination of sensitivity and specificity of detection (Herring et al. 2021). The ColoFuture study (extended into the U.S. as eAArly DETECT) is evaluating the effectiveness of these biomarkers to enhance ColoAlert’s technical profile to expand its capability to identify AA while increasing ColoAlert’s rates of diagnostic sensitivity and specificity.
The ColoFuture study is enrolling over 600 patients in the age range of 40-85, and the Company is targeting to report study results in 2023. ColoFuture’s eAArly DETECT study is on track to complete enrollment in Q1 2023, with results reported in the first half of 2023. Based on the study’s outcome, Mainz Biomed will decide on integrating the biomarkers into the ReconAAsense study, which is on track to enroll patients in the summer of 2023, with results reported in 2025.
The ReconAAsense study (ClinicalTrials.gov Identifier: NCT05636085) will form the basis of the data package for review by the U.S. Food and Drug Administration (FDA) to achieve marketing authorization. It is a prospective clinical study that will include approximately 15,000 subjects from 150 sites across the U.S. The study objectives include calculating sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) in average-risk subjects for CRC and AA. If successful, the Company’s mRNA and DNA-based CRC screening test will be positioned as the most robust and accurate at-home diagnostic screening test on the market, as it will not only detect cancerous polyps with a high degree of accuracy but has the potential to prevent CRC through early detection of precancerous adenomas.
PancAlert Research and Development Update: A novel screening test for pancreatic cancer achieved multiple preclinical milestones
During the year, Mainz Biomed announced that PancAlert met multiple preclinical milestones that support the continued development of this potential first-in-class diagnostic for this deadly cancer indication. These predefined milestones included achieving a specificity target, collecting a set of characterized clinical samples, selecting potential biomarker candidates, and developing a prototype biomarker test. The Company plans to continue PancAlert’s research and development to determine if a clinical trial is warranted.
PancAlert’s technical profile may include functioning as a stool-based test, mirroring the Company’s flagship product ColoAlert. Given the growing understanding of the role of the microbiome in pancreatic cancer, Mainz Biomed will evaluate real-time PCR-based multiplex detection of molecular-genetic biomarkers and other testing methods in stool samples and evaluate other collection methodologies, including saliva, urine, and blood.
The PancAlert project commenced in 2020 with a grant from the German Federal Ministry of Education and Research to develop a non-invasive early detection test for pancreatic cancer, a malignant neoplasm of the pancreas with one of the highest mortality rates of all major cancers. Each year, about 466,000 lives are taken globally, and it’s the seventh leading cause of cancer-related death worldwide.1 It has one of the lowest cancer survival rates, with typically late detection and poor outcomes with standard-of-care treatment(s). The 5-year overall survival rate is approximately 11% in the U.S.2 and 9% globally.3 If diagnosis occurs in the early stages of the disease, the survival rate is significantly higher. However, there are currently no routine screening options available.
Corporate Update: Bolstered balance sheet, made key appointments to the management team and enhanced its Board of Directors and Medical Advisory Board
Throughout 2022, Mainz Biomed operated in a position of financial strength, having successfully executed a USD 25.8 million public follow-on offering in January, which consisted of 1,725,000 ordinary shares priced at USD 15.00 per share.
During the year, to keep pace with product development and commercial growth, the Company made it a priority to bolster its leadership team. Key additions to the executive team include:
Darin Leigh, Chief Commercial Officer – Mr. Leigh is a former Abbott and Luminex executive with over 30 years of In Vitro Diagnostic (IVD) and life science experience.
Amy Levin, Vice President of Regulatory Affairs – Ms. Levin brings to Mainz Biomed over 20 years of regulatory affairs experience. Previously, she worked as Director, Roche Molecular Diagnostics (RMD) International Regulatory Affairs.
Jane Edwards, Vice President of Clinical Affairs – Ms. Edwards, has over 20 years of experience developing clinical trial strategies in diagnostics and medical devices. She was previously at L3 Healthcare, a full-service contract research organization, where she led clinical research and operations.
Frank Krieg-Schneider, Vice President of Development – Mr. Krieg has over 25 years of experience in the diagnostics and life science industry, including leading various divisions within Qiagen’s diagnostic and life science practice, heading up research and development for Diagnostic Sample Preparation and later serving as Head of Global Strategic Alliances.
Having achieved the transformational corporate growth milestone of going public onto Nasdaq in Q4 2021, Mainz Biomed made it a priority during 2022 to enhance the Company’s Board of Directors and advisory team in order to rely on their vast industry experience for the decisive inflections points in 2023 and beyond. Over the course of the year, Mainz Biomed appointed Dr. Heiner Dreismann as Chairman of the Board, Gregory Tibbitts to its Board of Directors, and added Dr. Michelle Pedrocchi, Dr. Rainer Metzger to its Strategic Advisory Board and Dr. Douglas Rex, Dr. Timothy Wang, and Dr. D. Kim Turgeon to the Medical Advisory Board.
Dr. Dreismann is the former Chief Executive Officer of Roche Molecular Diagnostics and is widely considered a pioneer in PCR, one of the most revolutionary techniques in molecular biology and genetics research. Mr. Tibbitts is an accomplished life science executive and certified public accountant with over 30 years of experience as a senior financial executive and board member of publicly traded and privately held companies.
COMMERCIAL PIPELINE DEVELOPMENT: FUTURE PRODUCTS
IN ADDITION TO THEIR FLAGSHIP COLOALERTPRODUCT, MAINZ BIOMED IS ALSO DEVELOPING:
Developing a novel early detection pancreatic cancer screening test
As GenX individuals age into their 40’s and 50’s they become part of the age group recommended to begin testing for CRC and more.
Mainz BioMed is currently developing proprietary genetic testing methods for pancreatic cancer.
Fighting what could soon become the world’s second most deadly cancer.*
Convenient stool test for at-home use.
Potential for over 50 million tests per year in Europe alone
Supported by federal grant from Germany’s Federal Ministry for Education and Research.
Cost of goods sold (COGS) & reimbursement analogous to ColoAlert program.
GlobeNewswire•4 days agoMAINZ BIOMED ANNOUNCES PARTNERSHIP WITH LABOR STABER TO EXPAND COLOALERT COMMERCIALIZATION IN GERMANYLabor Staber to actively market and sell ColoAlert to its physician and patient network.BERKELEY, Calif. and MAINZ, Germany, March 15, 2023 (GLOBE NEWSWIRE) — Mainz Biomed NV (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today a partnership with Dr Staber & Kollegen GmbH (Labor Staber) as part of its growing network of laboratories offering ColoAlert, its flagship product that is a highly efficac
GlobeNewswire•11 days agoMAINZ BIOMED LAUNCHES NUMBER OF EDUCATIONAL EVENTS IN GERMANY TO RAISE AWARENESS FOR CRC SCREENING AND EARLY DETECTIONSponsor of Gastro Update 2023, 2-day scientific and training events for gastroenterology professionals Patient Education Day in the City of Mainz, Germany, where the Company is headquartered Germany-based molecular diagnostic specialist to support local colorectal cancer communities BERKELEY, Calif. and MAINZ, Germany, March 08, 2023 (GLOBE NEWSWIRE) — Mainz Biomed NV (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of
GlobeNewswire•18 days agoMAINZ BIOMED RECOGNIZES COLORECTAL CANCER AWARENESS MONTH THROUGHOUT “BLUE” MARCH 2023Mainz Biomed to host several events for patients and healthcare professionals in Germany to increase awareness about the importance of early detection of colorectal cancer.BERKELEY, Calif. and MAINZ, Germany, March 01, 2023 (GLOBE NEWSWIRE) — Mainz Biomed NV (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, joins advocacy organizations around the world in recognizing Colorectal Cancer Awareness Month in March.
GlobeNewswire•19 days agoMAINZ BIOMED TO APPEAR ON CLEARTHINK IR’S VIRTUAL LIVE EVENT ON WEDNESDAY, MARCH 1, 2023 AT 12 NOON ETVirtual Fireside Chat via Paltalk PlatformBERKELEY, Calif. and MAINZ, Germany, Feb. 28, 2023 (GLOBE NEWSWIRE) — Mainz Biomed N.V., a molecular genetics diagnostic company specializing in the early detection of cancer, today announced that its Chief Financial Officer Bill Caragol will appear on ClearThink IR Virtual Live on Wednesday, March 1, 2023 at 12 noon ET. The ClearThink IR Virtual Live, powered by Paltalk, is hosting a different CEO every Wednesday at 12 noon ET for a “fireside chat” fol
GlobeNewswire•26 days agoMAINZ BIOMED ACQUIRES ENTIRE INTELLECTUAL PROPERTY PORTFOLIO FOR ITS COLORECTAL CANCER DIAGNOSTIC TEST PROGRAMTransaction entails executing option agreements to purchase IP portfolio associated with current ColoAlert product and the novel gene expression (mRNA) biomarkers being evaluated in ColoFuture/eAARLY DETECT Studies BERKELEY, Calif. and MAINZ, Germany, Feb. 21, 2023 (GLOBE NEWSWIRE) — Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today the execution of its option from Uni Targeti
GlobeNewswire•last monthMAINZ BIOMED EXPANDS EUROPEAN COMMERCIAL FOOTPRINT AND ENTERS MARKETS IN SPAIN AND UKContinued roll-out in Europe with onboarding of new lab partnersBERKELEY, Calif. and MAINZ, Germany, Feb. 15, 2023 (GLOBE NEWSWIRE) — Mainz Biomed NV (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today the establishment of commercial partnerships for ColoAlert with Marylebone Laboratory (Marylebone Lab LTD) and Instituto de Microecologia, two leading independent laboratories covering England and
GlobeNewswire•2 months agoMAINZ BIOMED LAUNCHES CORPORATE HEALTH PROGRAM IN GERMANY FOR COLOALERTPatient Access Initiative Addresses €1 Billion Annual Market in GermanyBERKELEY, US and MAINZ, Germany, Jan. 18, 2023 (GLOBE NEWSWIRE) — Mainz Biomed NV (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today the launch of a corporate health program in Germany for ColoAlert, its highly efficacious and easy-to-use screening test for colorectal cancer (CRC) being commercialized across Europe and in sel
GlobeNewswire•2 months agoMAINZ BIOMED PROVIDES YEAR-END 2022 CORPORATE REVIEWBERKELEY, US and MAINZ, Germany , Jan. 03, 2023 (GLOBE NEWSWIRE) — Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today a corporate summary for the fiscal year ended December 31, 2022. Key Commercial, Operational and Product Development Highlights Launched U.S.-based eAArly DETECT study by enrolling the first patient; study focused on the performance of Mainz Biomed’s mRNA biomar
GlobeNewswire•3 months agoMAINZ BIOMED ENROLLS FIRST PATIENT IN EAARLY DETECT STUDY EVALUATING INTEGRATION OF NOVEL MRNA BIOMARKERS INTO COLOALERTEnrollment remains on track to complete in Q1 2023 with results in 1H 2023Potential to identify advanced adenomas, a type of pre-cancerous polyp often attributed to colorectal cancer (CRC) BERKELEY, Calif. and MAINZ, Germany, Dec. 20, 2022 (GLOBE NEWSWIRE) — Mainz Biomed NV (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today the first patient has been enrolled in eAArly DETECT, Mainz’s U.S. extend
GlobeNewswire•3 months agoMAINZ BIOMED ANNOUNCES IRB APPROVAL AND INITIATION OF US PIVOTAL FDA CLINICAL STUDYReconAAsense study examining the clinical performance of mRNA and DNA test combined with a fecal immunochemical test for early detection of advanced adenoma and colorectal cancer to enroll 15,000 subjects across the United States, results expected in 2025Aims to enhance technical profile of the Mainz Biomed test to identify advanced adenomas (AA), a type of pre-cancerous polyp that can lead to colorectal cancer (CRC)Study will form the basis of the data package for review by the U.S. Food and Dr
GlobeNewswire•4 months agoMAINZ BIOMED APPOINTS AMY LEVIN AS VICE PRESIDENT OF REGULATORY AFFAIRS TO OVERSEE GLOBAL REGULATORY STRATEGIESFormer Roche executive Amy Levin, RAC, brings more than 20 years of regulatory affairs experience as an in vitro diagnostics (IVD) industry leaderBERKELEY, Calif. and MAINZ, Germany, Nov. 29, 2022 (GLOBE NEWSWIRE) — Mainz Biomed NV (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today the appointment of Amy Levin, RAC, as Vice President of Regulatory Affairs. In this role, Ms. Levin will be in char
GlobeNewswire•4 months agoMAINZ BIOMED TO PARTICIPATE IN DEUTSCHE EIGENKAPITALFORUM AND CANTOR FITZGERALD’S MEDICAL & AESTHETIC DERMATOLOGY, OPHTHALMOLOGY & MEDTECH CONFERENCEBERKELEY, Calif. and MAINZ, Germany, Nov. 22, 2022 (GLOBE NEWSWIRE) — Mainz Biomed NV (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today that members of its executive team will be participating in two notable conferences in November and December 2022, Deutsches Eigenkapitalforum 2022 and Cantor Fitzgerald’s Medical & Aesthetic Dermatology, Ophthalmology & MedTech Conference. Deutsches Eigenkapit
GlobeNewswire•4 months agoMAINZ BIOMED ANNOUNCES U.S. EXTENSION OF COLOFUTURE STUDY TO EVALUATE INTEGRATION OF NOVEL MRNA BIOMARKERS INTO COLOALERTeAArly DETECT expected to complete enrollment in Q1 2023 with results in 1H 2023Enhances ColoFuture’s demographic profile and expedites data read-out timelinePotential to identify advanced adenomas, a type of pre-cancerous polyp often attributed to colorectal cancer (CRC) BERKELEY, Calif. and MAINZ, Germany, Nov. 15, 2022 (GLOBE NEWSWIRE) — Mainz Biomed NV (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, anno
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We have another profile that is trading under a buck right now that sits on the Nasdaq that we want you to research. You know we loves these ones that are sitting under a dollar because of the massive swing potential.
Pull up IKT Immediately.
Inhibikase Therapeutics, Inc. (Nasdaq: IKT) is a clinical-stage pharmaceutical company developing therapeutics for Parkinson’s disease, or PD, and related disorders. (4)
The company’s multi-therapeutic pipeline has a primary focus on neurodegeneration and their lead program IkT-148009, an Abelson Tyrosine Kinase (c-Abl) inhibitor, targets the treatment of Parkinson’s disease inside and outside of the brain as well as other diseases that arise from Abelson Tyrosine Kinases. (4)
Let’s take a look at some of the catalysts for IKT:
ACTIVE CHART:
Inhibikase Therapeutics, Inc. (Nasdaq: IKT) kicked off 2023 with shares around the $.485 range on 1/3/2023 and reached an intraday high of $1.15 on 1/25/2023 capping off an impressive 137% move in less than a month according to price history available at Barchart.com. (11)
MARKET VALUATION:
In general, nano-cap companies have market capitalizations of less than $50 million.(8) Because nano-cap stocks are significantly smaller than mid-cap or large-cap companies, they have a higher potential to change valuation quickly. (9)Inhibikase Therapeutics, Inc. (Nasdaq: IKT) has a market cap of around $20.29M, as of 2/23/2023 according to MarketWatch.com. (10)
LOW FLOAT:
Stocks with low floats have the potential to present volatile swings if the market takes notice.(12)Typically, stocks with a float of 10-to-20 million shares are considered a low float. Inhibikase Therapeutics, Inc. (Nasdaq: IKT) has around 19.85M shares in its float according to Finviz.com. (14)
STRONG INSIDER OWNERSHIP:
High insider ownership typically signals confidence in a company’s prospects and ownership in its shares. (15) Inhibikase Therapeutics, Inc. (Nasdaq: IKT) insiders own over 21% of the shares as of 2/23/2023 according to Finviz.com. (14)
INNOVATIVE PIPELINE:
Inhibikase Therapeutics, Inc. (Nasdaq: IKT) is a clinical-stage pharmaceutical company that is focused on developing treatments for neurodegenerative and infectious diseases. Its innovative pipeline includes potential treatments for Parkinson’s disease, Alzheimer’s disease, and oncological diseases. (1)
RECENT FDA DECISION:
Inhibikase Therapeutics, Inc. (Nasdaq: IKT) received a favorable decision from the FDA allowing the company to immediately move forward with its Phase 2a clinical trial on IkT-148009 in Parkinson’s disease. (1)
ENCOURAGING CLINICAL TRIALS:
Inhibikase Therapeutics, Inc. (Nasdaq: IKT) has reported encouraging results from its Phase 1 clinical trials for its lead candidate, which could potentially be used to treat Parkinson’s disease with Phase 2 trials beginning in early 2023.(5)(6)
UNMET MEDICAL NEED:
Unmet Medical Need: Neurodegenerative and infectious diseases are significant and growing public health challenges, and there is a significant unmet medical need for effective treatments. (4)
ADDRESSABLE MARKET:
The market for treatments for neurodegenerative and infectious diseases is expected to be significant, providing an opportunity for Inhibikase Therapeutics, Inc. (Nasdaq: IKT) to capture a share of that market. (4)
INTELLECTUAL PROPERTY:
Inhibikase Therapeutics, Inc. (Nasdaq: IKT) has a strong intellectual property portfolio, including patents on its technology and methods for treating neurodegenerative and infectious diseases. (4)
DEVELOPED NOVEL PROTEIN:
Inhibikase Therapeutics, Inc. (Nasdaq: IKT) has developed novel protein kinase inhibitors against c-Abl, which the company believes can alter the disease course for Parkinson’s Disease. (4)
STRONG PARTNERSHIPS:
Inhibikase Therapeutics, Inc. (Nasdaq: IKT) has established strong partnerships with leading research institutions, including the National Institutes of Health (NIH) and the Michael J. Fox Foundation for Parkinson’s Research.(4)
EXPERIENCED MANAGEMENT:
Inhibikase Therapeutics, Inc. (Nasdaq: IKT) has an experienced management team with a track record of success in drug development and commercialization. (3)
In 2021, Inhibikase Therapeutics, Inc. (Nasdaq: IKT) commenced clinical development of IkT-148009, a small molecule Abelson Tyrosine Kinase inhibitor which the company believes can modify the course of Parkinson’s disease including its manifestation in the gastrointestinal tract, or GI. (4)
Results to date of the company’s completed Phase 1/1b Single and Multiple Ascending Dose escalation study (SAD and MAD, respectively) in older and elderly healthy volunteers and in mild to moderately advanced Parkinson’s patients have revealed important insights into the safety, tolerability, and pharmacokinetics of IkT-148009 in human subjects and patients. (4)
Results from the 88 older and elderly healthy Phase 1 subjects and 14 Phase 1b Parkinson’s patients have shown that IkT-148009 has a half-life of greater than 24 hours and just a 25 mg once-daily oral dose reached exposures that are consistent with the exposures to the drug that resulted in therapeutic efficacy in animal models of progressive Parkinson’s disease.
In addition, a review of unblinded adverse event data revealed that just nine adverse events of any grade were observed in subjects or patients on IkT-148009, and at least four of these adverse events could not be attributed to IkT-148009.(4)
The remaining five adverse events were of Grade 1 with no clinical significance.
FDA review of the Phase 1/1b data and the protocol for the Phase 2a three-month dosing study resulted in the FDA agreeing with the company’s view that it was appropriate for the Phase 2a study to begin, prompting them to close the Phase 1b study after two dosing cohorts.
The Phase 2a ‘201′ study began May 23, 2022 with the opening of the first site; the company has opened 16 of 34 selected sites as of November 1, 2022 and 11 patients have been randomized into the trial as of November 1, 2022.
120 treatment naïve patients are planned to be enrolled in this study which will dose patients with one of three planned doses of IkT-148009 or a placebo once daily for three months.
In addition to primary endpoints of safety/tolerability/pharmacokinetics, a hierarchy of 15 secondary endpoints measuring drug impact on motor and non-motor features of Parkinson’s disease in the brain or GI tract will be evaluated with descriptive statistics.
In July 2022, Inhibikase Therapeutics, Inc. (Nasdaq: IKT) filed its Investigational New Drug Application (IND) with the FDA in preparation to initiate the clinical development of IkT-001Pro, its prodrug of imatinib mesylate to treat Stable-phase Chronic Myelogenous Leukemia (SP-CML).
IkT-001Pro will be evaluated in a two-part dose finding/dose equivalence study in up to 56 healthy volunteers.
The study is designed to evaluate the steady-state pharmacokinetics of IkT-001Pro and determine the dose of IkT-001Pro equivalent to 400 mg imatinib mesylate, the standard-of-care dose for SP-CML. (4)
Following clearance of the IND by the FDA on August 26, 2022, the two-part study, now known as the ‘501’ study, was initiated with the first patient dosing anticipated by the beginning of December, completion of the first cohort anticipated by year-end 2022 and completion of the pharmacokinetic analysis anticipated in early first quarter 2023.(4)
Following the completion of both parts of this study and assuming the equivalent dose of IkT-001Pro relative to 400 mg imatinib mesylate is established, Inhibikase Therapeutics, Inc. (Nasdaq: IKT) will confer with the FDA to begin the NDA process following the proposed approval path for IkT-001Pro under the 505(b)(2) statute.
Inhibikase Therapeutics, Inc. (Nasdaq: IKT) will simultaneously pursue a superiority study comparing the selected doses of IkT-001Pro to standard-of-care 400 mg imatinib mesylate in SP-CML patients using a novel two-period wait list crossover switching study.(4)
Inhibikase Therapeutics, Inc. (Nasdaq: IKT)’s programs utilize small molecule, oral protein kinase inhibitors to treat neurodegenerative diseases and cancer. (4)
In Parkinson’s disease (PD), Inhibikase Therapeutics, Inc. (Nasdaq: IKT) has shown in animal models of progressive disease that its lead clinical candidate, IkT-148009, is a brain penetrant Abelson tyrosine kinase, or c-Abl inhibitor, that halts disease progression and reverses functional loss in the brain and reverses neurological dysfunction in the GI tract in animal models of human disease. (4)
The ability to halt progression and restore function was shown in animal models of progressive disease that mimic the rate of disease progression and the extent of functional loss in the brain and/or the GI tract as found in patients with PD. (4)
SMALL-MOLECULE MEDICATIONS WITH WORLD-CLASS POTENTIAL (21)
Inhibikase Therapeutics, Inc. (Nasdaq: IKT) used their innovative drug development platform called Re-engineering Approach with Metabolism Preserved (RAMP™) to create their initial product candidates. These candidates utilize a targeting strategy that involves blocking the activation of Abl kinases, which can be used to develop small-molecule medications capable of stopping the progression of diseases in various therapeutic areas including:(21)
A disease-modifying therapy that we believe halts the progression and reverses the functional loss arising from Parkinson’s disease in the brain and gastrointestinal (GI) tract while simultaneously reducing or clearing the toxic form of alpha-synuclein believed to be the cause of Parkinson’s. (21)
A treatment for stable-phase Chronic Myelogenous Leukemia (CML) with a prodrug of the anticancer agent imatinib that we believe will have a superior safety profile, improve oral absorption, lower the dose required for efficacy and suppress ongoing nausea, diarrhea, and vomiting associated with imatinib therapy. (21)
A companion therapeutic that we believe may remove the risk of JC polyomavirus (JCV) infection in the brain, the cause of Progressive Multifocal Leukoencephalopathy (PML). PML is a rare but rapidly fatal brain infection that arises from the migration of JCV from reservoirs in the body into the brain. The development of PML has been linked to treatment with more than 15 immunosuppressive medications that are used to treat cancer and autoimmune diseases, such as multiple sclerosis. (21)
Inhibikase Therapeutics, Inc. (Nasdaq: IKT) is also exploring development opportunities for the treatment of Multiple System Atrophy (MSA) and Dementia with Lewy Body (DLB). MSA is a neurodegenerative movement disorder which shares the hallmarks of c-Abl activation and alpha-synuclein chemical modification with Parkinson’s Disease, but arises in a different area of the brain than Parkinson’s itself. DLB is a Parkinson’s-like disease characterized by a primary cognitive deficit that arises from alpha-synuclein aggregate formation. (21)
Inhibikase Therapeutics, Inc. (Nasdaq: IKT) believes its therapeutic approach would be disease-modifying. (21)
Inhibikase Therapeutics, Inc. (Nasdaq: IKT)’s understanding of how and why PD progresses has led the company to believe that functional loss in Parkinson’s patients may be at least partially reversed although this has not been shown clinically. (21)
Based on the measurements in animal models, it is possible that patients treated with IkT-148009 may have their disease progression slowed or halted, the company may see a progressive reduction in the need for symptomatic or supportive therapy and/or ultimately eliminate the need for symptomatic therapy.(21)
REVERSING THE EFFECTS OF NEURODEGENERATIVE DISEASES
Inhibikase Therapeutics, Inc. (Nasdaq: IKT)’stherapeutics development programs focus on halting and reversing the effects of neurodegenerative diseases inside and outside of the brain. The company is also developing therapeutics that target the source of neurological infections.
Inhibikase Therapeutics, Inc. (Nasdaq: IKT)’s pipeline includes multiple products developed from their proprietary RAMP™ dr-ug innovation and prodrug technology engines that address multiple indications.
ABL KINASES AND CNS DISEASES
The protein kinase family known as the Abelson Tyrosine Kinase, or Abl kinases, has been shown to play a critical role in monitoring insults to brain neurons and regulating biological pathways that are associated with neurodegeneration.(21)
In addition, recent research has demonstrated that Abl kinases are essential checkpoint regulators that play a central role in Parkinson’s disease initiation and progression. (21)
The breakthrough cancer treatment, imatinib (marketed as Gleevec®), was the first FDA-approved Abl kinase inhibitor.
However, imatinib cannot treat in the brain nor inhibit the wildtype enzyme in patients, even though it has a favorable safety and pharmacology profile.
Applying Inhibikase Therapeutics, Inc. (Nasdaq: IKT)’s RAMP™ technology to imatinib, Inhibikase generated novel chemical entities that have:
Up to 25-fold enhanced potency against wildtype c-Abl relative to imatinib
Cross the blood-brain barrier and treat in the brain
Nearly identical route of metabolism to imatinib, thereby preserving the relationship between administered dose, drug safety and frequency of adverse events. This provides a level of predictability in a novel drug’s safety profile.
Inhibikase Therapeutics, Inc. (Nasdaq: IKT) believes these molecules have the potential to be dosed at low levels with an improved safety profile relative to other drugs in this class currently used to treat certain forms of blood and gastrointestinal cancers, resulting in a safer Abl kinase inhibitor that could be chronically and systemically administered for the treatment of their CNS indications. (21)
INHIBIKASE THERAPEUTICS, INC. (NASDAQ: IKT) RECEIVES FAVORABLE FDA DECISION ALLOWING THE COMPANY TO IMMEDIATELY MOVE FORWARD WITH PHASE 2A CLINICAL TRIALS. (1)
Phase 2a ‘201’ clinical trial will resume immediately at 50 and 100 mg doses (1)
Additional safety and pharmacokinetic information will be measured in healthy subjects at the 200 mg dose prior to implementation in the 201 trial (1)
“We are grateful for the expeditious review by the FDA of our response to the Clinical Hold on IkT-148009 in PD,” stated Milton H. Werner, Ph.D., President and Chief Executive Officer of Inhibikase Therapeutics, Inc. (Nasdaq: IKT)(1)
“We believe that we now have clarity on the FDA’s expectations as we move forward in the 201 clinical trial for IkT-148009. We are now working to re-open clinical trial sites and initiate screening and enrollment of patients for the trial following agreed upon updates to the Protocol and Informed Consent form. We anticipate completing these restart tasks by the end of the first quarter.“(1)
IkT-148009 is a c-Abl tyrosine kinase inhibitor that has been shown to halt disease progression, protect and restore lost neurons and to clear the underlying protein pathology in animal studies that suggests a causal link to the initiation and progression of disease in humans.
In lifting the clinical hold, the Agency based their decision on the Company’s Complete Response and Amendment dated December 21, 2022, as well as further commitments made on January 20, 2023 regarding ophthalmologic monitoring in the protocol of study IkT-148009-201 and various modifications to the Investigator Brochure.
The Agency requested that the Company measure the safety and steady-state pharmacokinetic (PK) profile of the 200 mg dose in six (6) healthy subjects prior to administration of the 200 mg dose in Parkinson’s patients.
The 201 trial will resume at the 50 mg and 100 mg dose immediately and the safety/PK measurement at 200 mg will be performed simultaneously. (1)
The Agency further requested the measurement of visual acuity and examination of the cornea and lens to complement the analysis of retina, macula and fundus that was already part of the ocular monitoring program in the 201 trial.
This monitoring program is consistent with the monitoring program for ocular pathology of other approved protein kinase inhibitors. To date, no ocular pathology has been observed in any trial participant administered IkT-148009.(1)
The Agency further requested removal of safety-related data in the Investigator Brochure for the primary metabolites of IkT-148009 to give the Agency time to review the underlying report in support of this safety data.(1)
With agreement on conditions for restart of the 201 trial and the lifting of the clinical hold on IkT-148009, the Company intends to seek a lifting of the Clinical Hold on its program focused on Multiple System Atrophy (MSA).(1)
INHIBIKASE THERAPEUTICS, INC. (NASDAQ: IKT): FOCUSED ON THE UNMET NEED IN THE MANAGEMENT OF PARKINSON’S DISEASE (25)
INHIBIKASE THERAPEUTICS, INC. (NASDAQ: IKT) ANNOUNCES ADVANCEMENT OF IKT-148009 PHASE 2 ‘201’ PROGRAM FOLLOWING FDA REVIEW
On June 13, 2022, Inhibikase Therapeutics, Inc. (Nasdaq: IKT) announced that it is advancing its Phase 2a study following review of the study protocol and Phase 1/1b data by the U.S. Food and Drug Administration. (25)
The 101 trial was a single and multiple ascending dose safety, tolerability and pharmacokinetics (PK) trial evaluating once daily administration of IkT-148009, the Company’s lead c-Abl inhibitor for the treatment of Parkinson’s disease. The study evaluated single doses up to 325 mg per day and multiple doses up to 100 mg in 88 older and elderly healthy adults and subsequently in 13 patients with mild to moderately advanced Parkinson’s disease. Clinical pharmacology of IkT-148009 in patients closely paralleled the clinical pharmacology of IkT-148009 in older healthy volunteers. IkT-148009 also demonstrated a favorable safety and tolerability profile up to a dose of 325 mg with no clinically significant adverse events observed.(25)
Following a review of IkT-148009 safety, tolerability and PK data in the first two cohorts of the 101 trial in Parkinson’s patients at 50 and 100 mg as well as the 201 trial protocol, the FDA agreed with the Company’s view that proceeding with the 201 trial was appropriate without restrictions. Based on this feedback, Inhibikase will continue to advance the 201 trial and end enrollment of the 101 trial.
“The 101 trial was the first in human study of our novel c-Abl inhibitor, IkT-148009, which has been designed to alter the course of Parkinson’s disease. The favorable safety, tolerability and PK data of IkT-148009 observed to date supports the continued pursuit of IkT-148009 clinically,” commented Milton H. Werner, PhD, President and Chief Executive Officer. (25)
“Based on these data and agreement with the FDA, we are very pleased to open enrollment in our 201 trial, just 17 months from the first-in-human dose of IkT-148009. This study will allow us to further evaluate the long-term safety and potential benefit of IkT-148009 in patients with Parkinson’s disease. With our first two trial sites actively screening patients, we expect to dose the first patient in the 201 trial by the end of the second quarter.” (25)
“The 101 trial and other early studies represent key milestones that have now laid the foundation for critical trials that will define the clinical efficacy and safety of IkT-148009 over longer time periods,” said Robert A. Hauser, MD, Director of the Parkinson’s Disease and Movement Disorders Center of the University of South Florida.(25)
The 201 trial is a 3:1 randomized, double-blind, twelve-week dosing trial that will measure the safety, tolerability and steady-state PK of IkT-148009 in untreated Parkinson’s patients as primary endpoints. The trial will also measure a hierarchy of Parkinson’s-related disease assessments in the brain and gut as secondary or exploratory endpoints. Inhibikase expects that at least 7 of 40 total sites will be open by the end of the second quarter this year.(25)
“Parkinson’s disease is an inexorably progressive disorder and a disease-modifying therapy that slows or halts progression remains a major unmet need in the management of this disorder,” said C. Warren Olanow, M.D., FRCPC, Professor Emeritus in the Department of Neurology and Department of Neuroscience at the Mount Sinai School of Medicine in New York, and Interim Chief Medical Officer of Inhibikase Therapeutics. (25)
“IkT-148009 has shown a good safety profile in initial SAD and MAD clinical studies as well as encouraging results in relevant humanizedanimal models of PD. We are excited to begin enrolling patients in our double blind placebo controlled 201 trial, which will evaluate the safety and potential disease modifying effects of IkT-148009 in a longer term setting for untreated Parkinson’s patients.“(25)
THE GLOBAL PARKINSON’S DISEASE TREATMENT MARKET IS EXPECTED TO REACH OVER $12 BILLION BY 2030. (27)
The market for treatments for neurodegenerative and infectious diseases is expected to be significant, providing an opportunity for Inhibikase Therapeutics, Inc. (Nasdaq: IKT) to capture a share of that market. (4)
The global neurodegenerative disorder therapeutics market grew from $15.86 billion in 2022 to $17.14 billion in 2023 at a compound annual growth rate (CAGR) of 8.1%. (28)
The market is expected to grow from $23.65 billion in 2027 at a CAGR of 8.4%.
Increased prevalence of neurodegenerative among the global population contributes to the growth of the neurodegenerative disorder therapeutics market.(28)
The increase in the geriatric population is attributed to the increased prevalence of neurodegenerative disorders. According to World Population Prospects, the number of people above 60 years of age will increase to 2.1 billion in 2050 and it is expected that people aged over 80 years will triple to 425 million in 2050. (28) According to the Alzheimer’s Association, around 5.8 million Americans are suffering from Alzheimer’s disease, and this number is projected to rise to around 14 million by 2050. The increased prevalence of neurodegenerative diseases among the aging population increases the demand for neurodegenerative disorder therapeutics thereby driving the market. (28)
INHIBIKASE THERAPEUTICS, INC. (NASDAQ: IKT) HAS ESTABLISHED STRONG PARTNERSHIPS WITH LEADING RESEARCH INSTITUTIONS(4)
Image Source (30)
Collaborations are central components of Inhibikase Therapeutics, Inc. (Nasdaq: IKT)’s strategy to build and advance our pipeline of product candidates.(4)
Through NIH research grants awarded to Dr. Werner, we have subcontracted research projects in the biochemistry of neurodegeneration and neurological infection to Johns Hopkins University, University of Massachusetts Medical School — Worcester Campus, University of Alabama at Birmingham and the Louisiana State University Shreveport.(4)
In oncology, Inhibikase Therapeutics, Inc. (Nasdaq: IKT) has subcontracted research work to the University of California, San Francisco and the CML Consortium and consulted with clinicians at the Memorial Sloan-Kettering Cancer Center. (4)
Inhibikase Therapeutics, Inc. (Nasdaq: IKT)’s research endeavors have been validated by private and public granting agencies, to include the Michael J. Fox Foundation, and the National Institute of Neurological Disease and Stroke, the National Cancer Institute and the National Institute of Allergy and Infectious Disease.
Inhibikase Therapeutics, Inc. (Nasdaq: IKT) believes that accessing external innovation is important to their success and they plan to remain active in accessing external innovation through business development activities and awarding of private, state and federal grants through institutions such as NIH and DoD.(4)
INHIBIKASE THERAPEUTICS, INC. (NASDAQ: IKT) FOCUSED ON DEVELOPING NOVEL THERAPEUTICS ACROSS A WIDE SPECTRUM INCLUDING NEURODEGENERATION, ONCOLOGY AND INFECTIOUS DISEASES. (24)
COMPANY HIGHLIGHTS:
Aim to discover novel therapeutics by modeling human disease using the Company’s Re-engineering Approach with Metabolism Preserved (RAMP) medicinal chemistry platform
IkT-148009: Lead Abelson Tyrosine Kinase (c-Abl) inhibitor program has the potential to be a disease-modifying treatment for Parkinson’s disease (PD) and related disorders. Phase 2a ‘201’ trial in Parkinson’s to begin screening patients in 1Q23.
IkT-001Pro: First oncology product is a BCR-Abl inhibitor with a potentially-improved safety profile to standard of care imatinib mesylate for leukemias and gastrointestinal cancers. Bioequivalence trial compared to 400 mg imatinib mesylate completed 1 cohort 4Q22 in the first part of a two-part study. Anticipated completion of bioequivalence in 1H23.
Robust patent portfolio with protection to 2033 (oncology) and 2036 (neurodegeneration).
$20.8 million in grants and contracts from NIH, DoD, the Michael J. Fox Foundation and the Georgia Research Alliance, all peer-reviewed; $63 million gross proceeds in investor capital in 2021, $10 million in 2023.
Highly-experienced management team, consultants, Board of Directors and Scientific Advisory Board
Dr. Milton Werner is the President and Chief Executive Officer of Inhibikase Therapeutics, a company developing novel protein kinase inhibitor therapeutics to treat neurodegenerative disease and viral infections inside and outside of the brain. Previously, Dr. Werner served as Vice President of Research at Celtaxsys, a cell-free immunotherapeutics company. From September 1996 until June 2007, Dr. Werner was a Head of the Laboratory of Molecular Biophysics at The Rockefeller University in New York City. Throughout his scientific career, Dr. Werner has been an innovator integrating chemistry, physics, and biology into a comprehensive approach to solving problems in medicine, including an explanation of the origin of “maleness” in humans, the mechanistic basis of several forms of leukemia and lymphoma and, more recently, the development of therapeutics that can halt and potentially reverse functional loss in neurodegenerative disease.
Dr. Werner is the author or co-author of more than 70 research articles, reviews, and book chapters and has given lectures on his research work throughout the world. He is the recipient of numerous private and public research grants totaling more than $30 million. He is the recipient of several awards, including the Naito Memorial Foundation Prize, the Young Investigator Award from the Sidney Kimmel Cancer Foundation, the Research Chair from the Brain Tumor Society, and a $1 million Distinguished Young Scholars in Medical Research Award from the W. M. Keck Foundation. Dr. Werner received his Doctor of Philosophy in Chemistry from the University of California, Berkeley, and his Bachelor of Science in Biochemistry from the University of Southern California, and he was an NIH intramural postdoctoral fellow prior to his tenure at the Rockefeller University.
C. WARREN OLANOW MD, FRCPC, FRCP (HON.)
Medical Consultant and CEO of Clintrex Research Corporation
Dr. C. Warren Olanow is Interim Chief Medical Officer of Inhibikase and Chief Executive Officer of CLINTREX. He is the former Henry P. and Georgette Goldschmidt Professor and Chairman of the Department of Neurology at the Mount Sinai School of Medicine in New York City, where he is presently Professor Emeritus in the Department of Neurology and in the Department of Neuroscience. Prior to joining Mount Sinai, he served on the faculties of McGill University, Duke University, and the University of South Florida. He is the former President of the Movement Disorder Society, past President of the International Society of Motor Disturbances, and former Treasurer of the American Neurological Association. He has served on the Board of Directors of the National Space Biomedical Research Institute and the executive committee of the Michael J. Fox Foundation Scientific Advisory Board, and he is the former Chairman of the Scientific Advisory Board of the Bachmann-Strauss Parkinson and of the Dystonia Foundation. Dr. Olanow is the former Co-Editor-in-Chief of the journal, Movement Disorders. He has been principal investigator of numerous studies leading to approval of drugs and devices for treating neurodegenerative diseases. Dr. Olanow received his medical degree from the University of Toronto, performed his neurology training at the New York Neurological Institute at Columbia Presbyterian Medical Center at Columbia University, and undertook postgraduate studies in neuroanatomy at Columbia University.
JOSEPH FRATTAROLI, CPA
Chief Financial Officer
Joseph Frattaroli has served as our Chief Financial Officer since April 2018. Mr. Frattaroli is a certified public accountant with more than 15 years of experience in public company filings and compliance for Nasdaq and OTC Markets companies. He founded Flagship Consulting, Inc. in January 2010, through which he has provided chief financial officer and consulting services for several emerging biopharmaceutical and medical device companies, with responsibilities that included capital formation, deal structuring, and assisting private companies in their transition to becoming publicly traded SEC registrants.
He has also served as an independent consultant to Danforth Advisors from July 2015 until joining Inhibikase, providing interim chief financial officer and strategic advisory services to emerging public and private biotechnology and biopharmaceutical clients. Mr. Frattaroli received his Bachelor of Science in Accounting from Salem State University and was certified as a public accountant while employed by Ernst & Young, LLP.
DAN WILLIAMS
Controller
Dan Williams acts as the Company’s controller through his own company Startup Personnel, LLC.
TERENCE KELLY, PH.D.
Medicinal Chemistry Consultant
Dr. Terence Kelly is a 30-year pharmaceutical industry veteran and has served as a member of the board of directors of Cardax since June 2014. He is a founder of Kelly Pharma Research Consulting, LLC, and has served as its President since January 2010. From June 2010 to July 2017, he held several positions at CoMentis, including most recently President and CEO. From July 2002 to December 2009, he served as Vice President of Medicinal Chemistry at Boehringer Ingelheim Pharmaceuticals, where he, developed processes for the RAMP drug discovery program.
ROGER RUSH, PH.D.
Preclinical Project Management
Dr. Roger Rush is an experienced veteran of the pharmaceutical industry with more than 30 years of experience working in the United Kingdom and the U.S. for small and large pharmaceutical companies and contract research organizations and is now based in the Greater Boston area. His major career focus has been on preclinical research and development, safety assessment, and the translation of discovery research molecules into clinical development. He has contributed to more than 20 IND, CTA, and product license submissions and approved drugs, including nicardipine (Cardene), ranolazine (Ranexa), Foscan, and zileuton (Zyflo CR). He has been a principal of Allon Preclinical Consulting, LLC since 2015.
From March 2012 to December 2014, he was Vice President, Preclinical Development for Idenix Pharmaceuticals, Inc., a wholly owned subsidiary of Merck & Company, Inc., where he managed the DMPK, toxicology, and discovery research that led to the identification of lead molecules to treat Hepatitis C virus. His work has spanned numerous therapeutic areas, including anti-inflammatory, anti-allergy, arthritis, anti-infectives, CNS, cardiovascular, oncology, genitourinary, and anti- antihyperlipidemic agents. He received his Bachelor of Science and Doctor of Philosophy in Biochemistry from the University of Surrey in the United Kingdom.
SURENDRA SINGH, PH.D.
Chemistry and Manufacturing Controls
Dr. Surendra Singh is an expert in chemical process research and development from lead optimization to launch, technology transfer, and API manufacturing. From 2001 to 2011, he served various roles at Sunovion Pharmaceuticals Inc. and its predecessor, Sepracor Inc., including as a director of chemical process research, and has served as a chemistry, manufacturing, and control consultant for AVEO Oncology, RestorGenex Corporation, Verastem Oncology, and Syner-G Pharma Consulting, LLC. Dr. Singh received his doctoral degree from the Indian Institute of Technology in 1991 and was a postdoctoral fellow at The Ohio State University. Dr. Singh establishes and manages the commercial process, global outsourcing, and global vendor management as well as participates in all aspects of the drafting and review of regulatory documents, from IND to NDA.
MERRILL M. KRAINES, PARTNER, MCDERMOTT, WILL & EMERY
Outside General Counsel
Merrill M. Kraines is a partner in the Health Sciences practice of McDermott, Will and Emery LLP, resident in the New York office. Mr. Kraines is primarily engaged in corporate, securities, and mergers and acquisitions matters. He leads the life sciences, technology, and emerging growth practices in New York. Mr. Kraines represents many life sciences companies, including biotechnology, therapeutic, diagnostic, and medical device companies.
He has also represented or been involved in transactions concerning a variety of other growth companies in all phases of business and finance in many industries, including software, Internet, health care, IT, alternative energy, financial services, IT consulting, educational publishing, entertainment, office products, advertising, telecommunications, paper, and many other companies. These companies have ranged from start-ups to large public concerns.
VOISIN LIFE SCIENCE CONSULTING
FDA and EU Regulatory Consultants
Voisin Life Science Consulting is a regulatory affairs consultancy with extensive regulatory experience, representing pharmaceutical and biotechnology companies at the U.S. FDA and EMA. The company has helped to guide development programs for small molecules and biologics through all phases of regulatory review.
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We have another exciting profile for you for for today’s session. This one operates in a unique, niche sector with a bright future ahead of it. With a recent uplisting to the NASDAQ, Clearmind Medicine, Inc. (NASDAQ: CMND) is a company to look at closely!
The world is in a mental health crisis, with near all-time level highs of depression, PTSD, anxiety, and addiction. The pandemic has negatively affected many people, impacting their mental health on many levels. The current mental health treatments available, such as SSRIS for depression and rehab for addiction, may be effective, but also leave far too many people behind. Plus, the treatment for these conditions is massive, raking in billions of dollars a year, even if they aren’t effective. There needs to be a solution and the growing psychedelics movement might be it. Early scientific evidence is showing that treatments such as MDMA therapy for PTSD, psilocybin therapy for depression, and ketamine therapy for addictions, are much more effective than current treatments!
Are we looking at another sector before it goes mainstream? We all know how many millionaires were made from the MJ Sector. It is certainly worth noting that voters passed the 2020 Oregon Ballot Measure 109, making it the first state to both decriminalize psilocybin and also legalize it for therapeutic use. Colorado followed with the 2022 Colorado Ballot Measure 122.
Clearmind Medicine Inc. (Nasdaq: CMND) is a psych-e-delic pharmaceutical biotech company focused on the discovery and development of novel psych-e-delic-derived therapeutics to solve widespread and underserved health problems, including alcohol use disorder.(15)
Its primary objective is to research and develop psych-e-delic-based compounds and attempt to commercialize them as regulated medicines, foods or supplements.(15)
The Company’s intellectual portfolio currently consists of seven patent families.(15)
Clearmind Medicine Inc. (Nasdaq: CMND) intends to seek additional patents for its compounds whenever warranted and will remain opportunistic regarding the acquisition of additional intellectual property to build its portfolio.(15)
MAJOR CATALYSTS TO RESEARCH FOR CMND:
GROUNDBREAKING PSYCHEDELIC MEDICINE:
Clearmind Medicine Inc. (Nasdaq: CMND)(CSE: CMND) is a biotech company that is focused on the discovery and development of novel psych-e-delic-derived therapeutics to solve major under-treated health problems to treat mental health disorders like depression, anxiety, and addiction. (23)
STRONG INTELLECTUAL PROPERTY:
Clearmind Medicine Inc. (Nasdaq: CMND)(CSE: CMND) has a strong intellectual property portfolio, with multiple patents and patent applications covering its psych-e-delic drug candidates. On February 22, 2023, the company announced it has filed three provisional patent applications with the United States Patent and Trademark Office (USPTO), for unique combinations of future psych-e-delic-based compounds.(23)
GROWING MARKET OPPORTUNITY:
There is a massive market potential for Clearmind Medicine Inc. (Nasdaq: CMND)(CSE: CMND)as the company focuses on a huge untapped market with yearly economic impact costing the U.S. over $249 billion.(6)Not to mention the market for psych-e-delic medicine is growing rapidly, with the global market size projected to reach $100 billion according to Tania Gonsalves, an analyst for Canaccord Genuity Capital Markets. (24)
ROBUST PIPELINE:
Clearmind Medicine Inc. (Nasdaq: CMND)(CSE: CMND) has a robust pipeline of psych-e-delic drug candidates in various stages of development, with a focus on developing treatments for Alcohol Use Disorder (AUD), major depressive disorder, PTSD, and addiction. (26)
FIRST-TO-MARKET:
Clearmind Medicine Inc. (Nasdaq: CMND)(CSE: CMND) positions to deliver a first-to-market psych-e-delic-based treatment for Alcohol Use Disorder(AUD), targeting a more than $395 million alcohol-substitute market opportunity. (27)
EXPERIENCED LEADERSHIP:
Clearmind Medicine Inc. (Nasdaq: CMND)(CSE: CMND) has—and continues to build—a culture of world-leading innovators in novel psych-e-delic treatments. Clearmind has a team of experienced leaders in the biotech and pharmaceutical industries who are focused on driving the company’s success. (25)
STRATEGIC PARTNERSHIPS:
Clearmind Medicine Inc. (Nasdaq: CMND)(CSE: CMND) has established strategic partnerships with leading academic institutions and researchers to advance its drug development programs and bring new treatments to market. (27)
MARKET INTEREST:
Clearmind Medicine Inc. (Nasdaq: CMND)(CSE: CMND) has already garnered significant interest from the market with its recent listing on Nasdaq and CSE and strong performance since its IPO and climbing over 66% in 7 business days when it put in an intraday low of $3.06 on 1/3/2023 and climbed up to an intraday high of $5.10 on 1/11/2023 according to Barchart.com.(4)
EXTREMELY LOW FLOAT:
Clearmind Medicine Inc. (Nasdaq: CMND)(CSE: CMND) has less than 1.2M shares available in its public float according to Finviz.(1) Low float stocks have the potential to present significant swings if active market participants take notice.(2)
BIOTECH AND PHARMACEUTICAL COMPANIES ARE RESPONSIBLE FOR SOME OF THE MOST INNOVATIVE DEVELOPMENTS IN THE WORLD. (10)
Biotechnology and Pharmaceutical companies must bear significant costs to develop new products and processes. Extensive research time is a key reason for these costs. However, recreating the products and processes of competitors is relatively inexpensive. (10)
Adequate patents on developments and the research that led to them help biotechnology and pharmaceutical businesses reduce the risk of copied products entering the marketplace. (10)
Intellectual Property Rights Can Be The Final Product. (10)
Not every biotechnology or pharmaceutical company sees a product through from design to manufacture. (10)
In many cases, small biotech and pharma firms license their patented innovations to larger firms with the resources capable of producing them and taking them to market. (10)
The success of these small companies depends on whether those companies can convince market participants that their firms have a sound intellectual property strategy. (10)
This strategy, which centers on patents, helps minimize the risks for those who plan to finance these types of companies. (10)
Clearmind Medicine Inc. (Nasdaq: CMND)(CSE: CMND) has a strong intellectual property portfolio, with multiple patents and patent applications covering its psych-e-delic drug candidates. (23)
On February 22, 2023, the company announced it has filed three provisional patent applications with the United States Patent and Trademark Office (USPTO), for unique combinations of future psych-e-delic-based compounds. (23)
PATENTS KEEP THE BIOTECHNOLOGY AND PHARMACEUTICAL INDUSTRIES MOVING FORWARD (10)
Once a biotechnology or pharmaceutical firm acquires a patent, details of its technology enter the public domain. (10)The development’s description, including its advantages and claims about the product’s usage, production methods, and the product itself, are all part of the patent. (10)
Patents allow competing companies to learn what other firms are doing and be inspired to create their own innovations, in much the same way that the articles published in scientific journals inspire new research ideas and discovery efforts. (10)
Patents drive the biotechnology and pharmaceutical industry forward, which is good news for these exciting sectors and society as a whole. (10)
Patents also strengthen the biotechnology and pharmaceutical companies they protect. Firms feel encouraged to continue their research when they know they can protect the results of their efforts. These firms are also more likely to have the funds if their patented goods are a success. (10)
Patented biotech and pharmaceutical goods have the greatest value near the end of their patent period. (10)
By that time, these goods have been through clinical trials, received regulatory approval, entered the market, and hopefully gained acceptance from the public, all without any competitors. (10)
Biotech and Pharmaceutical companies are responsible for some of the most innovative developments in the world. (10)
Without the potential for patent profits, there would be no reward for innovative ideas that lead to beneficial products. (5)
These products are the technological advances that make life better.(5)
Pharmaceutical companies have the ability to develop new dr-ugs that can prolong life and provide cures to diseases that affect people worldwide.(5)
Patents are especially important to these dr-ug companies because they can guarantee profit and make all the time and cost put into developing their new dr-ug worthwhile. (5)
A patent is an economic catalyst to these pharmaceutical companies who push to research new and beneficial dr-ugs on the premise that they will be able to reap rewards by way of profits.(5)
Profits for patented pharmaceuticals represent a reward that pharmaceutical companies earn through years of research and development and only then will they be able to profit from their work. (5)
On December 21, 2022, Clearmind Medicine Inc. (Nasdaq: CMND)(CSE: CMND)announced that it has been granted a patent from the United States Patent and Trademark Office (USPTO) for the use of its proprietary MEAI as an alcoholic beverage substitute. Similar patents have already been granted to Clearmind for the MEAI-based alcohol substitute in Europe and India. (28)
The development– U.S. Patent No.11,077,072 B2 – is a major milestone for Clearmind Medicine Inc. (Nasdaq: CMND)(CSE: CMND), given the increasing popularity and growth in sales of non-alcoholic wine, beer and spirits. According to the information services firm NielsenIQ, the market for such non-alcoholic beverages in the U.S. in August 2022 stood at $395 million per year, showing a year-on-year growth of +20.6%. (28)
THE RISE OF PSYCH-E-DELIC DR-UG DISCOVERY IN THE BIOTECH AND PHARMACEUTICAL INDUSTRIES(5)
“With psych-e-delic drugs showing promise with mental health issues, many have just begun to push into a space that could be worth up to $100 billion”, according to Tania Gonsalves, an analyst for Canaccord Genuity Capital Markets… As quoted by Psych-e-dlic Spotlight. Gonsalves added, “the companies that will emerge as the winners will have deep pockets, patentable products and a well-thought-out reimbursement strategy.” Helping, more cities are just beginning to decriminalize psychedelics, like psi-lo-cybin. (24)
For example, Denver, Oakland, and Santa Cruz have legalized the use of psi-lo-cybin. (24)
Oregon also became the first state to legalize psi-lo-cybin in a therapeutic setting. (24)
With excitement growing with psych-e-delics, one company to keep an eye on is Clearmind Medicine Inc. (Nasdaq: CMND)(CSE: CMND).
For decades, psych-e-delic dr-ugs like L-S-D, psil-o-cybin (magic mush-rooms), and cann-a-bis have been associated with societal outliers, hedonism, and general recklessness.(5)
But research into psy-ch-e-delics has come a long way, and biotech and pharmaceutical companies aiming to harness the therapeutic potential of psy-ch-e-delic are proliferating.(5)
The market appetite for psych-e-delics has also increased significantly over the last few years, with big money gravitating bullishly toward this flourishing sector.(5)
Despite social controversy, there is no denying that science has shown potential for psyche-del-ics to ease or even cure mental health disorders such as depression, anxiety, and trauma.(5)
Dr-ug discovery companies are also emerging that are isolating active compounds in cann-a-bis – cann-a-binoids – for therapies with better precision, bioavailability, and safety than the plant alone. (5)
And as with other progressive movements in the biopharma industry, artificial intelligence (AI) is contributing to the development of psych-e-delic therapeutics. (5)
Most psych-e-delic companies are founded with the intent to cure a mental health disorder, such as depression, anxiety, or post-traumatic stress disorder (PTSD).(5)
Clearmind Medicine Inc. (Nasdaq: CMND) is focused on the massive and relatively untapped binge behaviors and addictions market.
Clearmind’s flagship treatments are focused on Alcohol Use Disorder(AUD), which is incredibly common. It varies from mild to excessive, and describes a person’s inability to restrict their alcohol consumption, despite negative social, occupational, or health consequences.(6)
Alcohol Use Disorder(AUD) encompasses conditions that are referred to as alcohol abuse, alcohol dependence, alcohol addiction, and alcoholism. (19)
AUD is a medical condition characterized by an impaired ability to stop or control alcohol use despite adverse social, occupational, or health consequences. (19)
Considered a brain disorder AUD can be mild, moderate, or severe. (19)
The good news is that no matter how severe the problem may seem, evidence-based treatment with behavioral therapies, mutual-support groups, and/or medications can help people with AUD achieve and maintain recovery.(20)
According to a national survey, 14.1 million adults ages 18 and older (5.6 percent of this age group) had AUD in 2019. (20)
Among youth, an estimated 414,000 adolescents ages 12–17 (1.7 percent of this age group) had AUD during this timeframe.(20)
What Increases the Risk for AUD? A person’s risk for developing AUD depends, in part, on how much, how often, and how quickly they consume alcohol. (20)
Alcohol misuse, which includes binge drinking and heavy alcohol use, over time increases the risk of AUD.(20)
Other factors also increase the risk of AUD, such as:
Drinking at an early age. A recent national survey found that among people ages 26 and older, those who began drinking before age 15 were more than 5 times as likely to report having AUD in the past year as those who waited until age 21 or later to begin drinking. The risk for females in this group is higher than that of males. (20)
Genetics and family history of alcohol problems. Genetics play a role, with heritability approximately 60 percent; however, like other chronic health conditions, AUD risk is influenced by the interplay between a person’s genes and their environment. Parents’ drinking patterns may also influence the likelihood that a child will one day develop AUD.(20)
Mental health conditions and a history of trauma. A wide range of psychiatric conditions—including depression, post-traumatic stress disorder, and attention deficit hyperactivity disorder—are comorbid with AUD and are associated with an increased risk of AUD. People with a history of childhood trauma are also vulnerable to AUD.(20)
THE SOLUTION
Breaking the Cycle Clearmind Medicine Inc. (Nasdaq: CMND) believes that MEAI breaks the vicious binge-drinking cycle at the decision point to drink more alcohol,by potentially innervating neural pathways such as 5-HT1A that lead to “sensible behavior.”(6)
Non-Addictive Anecdotal reports and pre-clinical in-vivo results indicate on the self-limiting property of MEAI—unlike traditional treatments.(6)
ExpansivePotential The literature shows that 5-HT1A receptors are associated with controlling craving behavior across the board. This indicates that MEAI may have a wide range of applications beyond binge drinking.(6)
SUCCESSFUL PRECLINICAL RESULTS IN MEAI TREATMENT FOR ALCOHOL CONSUMPTION.(6)
Pre-clinical trial demonstrated high safety profile in addition to a significant suppressive effect on alcohol consumption.(6)
Clearmind conducted preclinical trials, training groups of mice to consume alcohol for five weeks.(6)
The groups were then given a daily dose of MEAI, with intermittent access to alcohol and water.(6)
After two weeks, researchers found a significant reduction in alcohol consumption in mice receiving MEAI.(6)
The untreated control group showed no significant reduction in alcohol consumption.(6)
No SAEs or treatment-related histological changes were observed amongst all MEAI treatment groups compared to control naive and vehicle animals in all the examined organs.(6)
CLEARMIND MEDICINE INC. (NASDAQ: CMND) RECENTLY ANNOUNCED THE INITIATION OF CLINICAL BATCHES OF PRODUCTION OF ITS NOVEL PSYCH-E-DELIC-DERIVED DR-UG CANDIDATE.(15
Clearmind Medicine Inc. recently announced the initiation of clinical batches of production of its novel psych-e-delic-derived dr-ug candidate, the MEAI- based molecule- CMND-100.(15)
The produced batches will be used in the Company’s upcoming first in human (FIH) clinical trial evaluating the proprietary dr-ug candidate compound CMND-100 for the treatment of Alcohol Use Disorder (AUD).(15)
Following MEAI’s synthesis development process, the compound is being produced under GMP (Good Manufacturing Process) conditions to comply with FDA requirements.(15)
The clinical batches production is made possible due to prior successful production of MEAI dr-ug substance that was used in the Company’s pre- clinical studies designed to evaluate the safety of its innovative compound.(15)
“Clearmind continues its progress toward FIH clinical trials,” said Dr. Adi Zuloff-Shani, Clearmind’s Chief Executive Officer. (15)
“This milestone joins other achievements we’ve made in a relatively short period. Non-clinical data generated to date, demonstrate that our MEAI- based treatment has the potential to treat broad range of addictions and binge behaviors such as AUD.”(15)
“Like other addictions, AUD is a chronic relapsing brain disorder characterized by an impaired ability to stop or control alcohol use,”she added. (15) “Alcohol abuse is the third most-common preventable cause of death in the United States, where almost 6% struggle with this condition.”(15)
Image Source (32)
The Company previously announced that it completed a highly constructive Pre-Investigational New Dr-ug Application (“pre-IND”) meeting with the U.S. Food and Dr-ug Administration (“FDA”) to discuss the development of CMND-100.(15)
CLEARMIND MEDICINE INC. (NASDAQ: CMND)’S RECENT IPO & NASDAQ UPLISTING
Clearmind Medicine Inc. (Nasdaq: CMND) was recently listed on the Nasdaq market and could be a severely undervalued company heading into 2023 with a market cap of less than $9M and its share price in the $3 – $4 range as of 12/7/22 according to MarketWatch.com. (3)
On November 14, 2022, Clearmind Medicine announced the pricing of its US $7.5 million public offering and uplisting to the Nasdaq Capital Market. (15)
Aegis Capital Corp. acted as the sole bookrunner on the offering and uplisting.(17)
Aegis Capital Corp. has been in the wealth management and investment banking business since 1984. The company is dedicated to providing corporate finance, strategic advisory and related services to public and private companies across multiple sectors and regions. Aegis also provides research and sales and trading services to institutional investors. (17)
But Clearmind Medicine Inc. (Nasdaq: CMND) has less than 1.2M shares available in its public float according to Finviz.(1)Low float stocks have the potential to present significant swings when active market participants take notice.(2)
CLEARMIND MEDICINE INC. (NASDAQ: CMND)(CSE: CMND) FILES THREE PROVISIONAL PATENT APPLICATIONS WITH THE UNITED STATES PATENT AND TRADEMARK OFFICE (USPTO), FOR UNIQUE COMBINATIONS OF FUTURE PSYCH-E-DELIC-BASED COMPOUNDS. (31)
Clearmind Medicine Inc. (Nasdaq: CMND)(CSE: CMND) submitted patent applications to protect the novel compounds
Tel Aviv, Israel, Feb. 22, 2023 (GLOBE NEWSWIRE) – SciSparc Ltd. (Nasdaq: SPRC) a specialty clinical-stage pharmaceutical company focusing on the development of therapies to treat disorders of the central nervous system, announced today that as part of its ongoing collaboration with Clearmind Medicine Inc. (Nasdaq: CMND) (CSE: CMND),(FSE: CWY), a biotech company focused on discovery and development of novel psychedelic-derived therapeutics to solve major under-treated mental health problems, Clearmind has filed three provisional patent applications with the United States Patent and Trademark Office (USPTO), for unique combinations of future psych-e-delic-based compounds. (31)
The patent applications refer to novel proprietary combinations of 3,4 Methyl-enedioxymeth-am-phetamine (M-D-M-A), Ibogaine and Ket-a-mine each with SciSparc’s Palmitoylethanolamide (PEA), the active ingredient of its proprietary CannAmide™. (31)
Overall, as part of this collaboration, six other patent applications have been filed by Clearmind with the USPTO for various combinations, three of them for the combination of SciSparc’s PEA with Clearmind’s MEAI compound (5-methoxy-2-aminoindane) for the treatment of alcohol use disorder, treatment of co-caine addiction and treatment of obesity and its related metabolic disorders, and recently for novel proprietary combinations of ly-sergic ac-id diethylamide (“L-S-D”), psil-o-cybin , and N,N-di-meth-yltryptamine (“D-M-T”) and SciSparc’s PEA, the active ingredient of its proprietary CannAmide™. (31)
As part of the collaboration agreement, any assets generated from the collaboration will belong to both companies.
SciSparc Ltd. is a specialty clinical-stage pharmaceutical company led by an experienced team of senior executives and scientists. SciSparc’s focus is on creating and enhancing a portfolio of technologies and assets based on cann-a-binoid pharmaceuticals. (31)
With this focus, the Company is currently engaged in the following drug development programs based on T-H-C and/or non-psych-o-active C-B-D: SCI-110 for the treatment of Tourette Syndrome, for the treatment of Alzheimer’s disease and agitation; SCI-160 for the treatment of pain; and SCI-210 for the treatment of ASD and status epilepticus. (31)
The Company also has a wholly-owned subsidiary whose business focuses on the sale of hemp-based products on the Amazon.com marketplace.
MANAGEMENT
‘
NEWS
FEBRUARY
ISRAEL-BASED CLEARMIND MEDICINE FILES PATENT APPLICATIONS FOR THREE UNIQUE COMBINATIONS OF FUTURE PSYCHEDELIC-BASED COMPOUNDS
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Strategic partnership with Zimmer Biomet (NYSE:ZBH, ~$27B mkt cap) to exclusively commercialize and distribute EVO® diagnostic electrodes; accelerated payment of $3.5 million received in August 2022
Neurone® Receives FDA 510(k) Clearance to Market its Evo® sEEG System for Less than 30 Day Use
****Breaking News This Morning***** NeuroOne® Awarded U.S. Patent Covering Novel and Proprietary Thin Film Electrode Platform
I hope that you have been paying attention to the markets. I am seeing new opportunities pop up now on a regular basis now that weren’t there just a few weeks back. Yesterdays profile saw a lot of action and traded as low as 3.10 and the average trade on the session was 3.28 and today during the session we saw it hit 4.02 for a 22% move overnight off of yesterday’s average trade all while the market took a hit.
Take a look at this chart. You can see that todays profile it is no stranger to monster moves and wild swings.
The last time we looked at it, this one opened at 1.05 and about 2 weeks later it tapped 2.80.
Pull up NMTC Immediately.
NMTC is a medical technology company focused on the development and commercialization of a minimally invasive and high-definition/high-precision electrode technology platform used for acute diagnostics and chronic treatment across a wide range of neurologic conditions including epilepsy, Parkinson’s disease, dystonia, essential tremors, and chronic pain due to failed back surgeries. NeuroOne’s electrodes offer the potential to reduce the number of hospitalizations and surgical procedures, lower costs, and improve patient outcomes by offering combination diagnostic and therapeutic functions such as EEG recording and tissue ablation and/or chronic stimulation. In addition to NeuroOne’s FDA-cleared EVO® diagnostic electrodes, a combination recording and radiofrequency (RF) ablation technology, OneRF®, is currently under development as the Company’s first therapeutic device. Other research and development programs include revolutionary new thin-film-based (chronic) electrodes for spinal cord stimulation (SCS) and deep brain stimulation (DBS), and the potential application of the Company’s technology for artificial intelligence and machine learning.
NeuroOne® Awarded U.S. Patent Covering Novel and Proprietary Thin Film Electrode Platform
New patent adds value to NeuroOne’s growing patent portfolio in the U.S. and abroad
EDEN PRAIRIE, Minn., March 7, 2023 /PRNewswire/ — NeuroOne Medical Technologies Corporation (NASDAQ: NMTC) (“NeuroOne” or the “Company”), a medical technology company focused on improving surgical care options and outcomes for patients suffering from neurological disorders, today announces it has been awarded a patent from the United States Patent and Trademark Office relating to its novel and proprietary electrode technology.
The patent, titled “Improved Neural Depth Probes and Related Systems and Methods,” adds to NeuroOne’s intellectual property portfolio, and is focused on a layered thin film neural depth electrode. The electrode could have potential applications in a wide variety of neurological procedures for both diagnostic and therapeutic use. Conditions that could potentially benefit from this technology include epilepsy, Parkinson’s disease, chronic back pain due to failed back surgeries, and mood- based disorders associated with depression, severe OCD, etc.
In addition to this patent, NeuroOne’s patent portfolio includes three licensed patents, eight pending U.S. applications, and several foreign applications covering a wide variety of thin-film electrode technologies, including both neural and spinal cord electrodes having unique properties to optimize the functionality and minimized profile of those electrodes, enabling less invasive surgeries. More specifically, the inventions described in the patent applications include electrodes and related devices with drug delivery capabilities, spinal cord stimulation electrodes, ablation electrodes, and electrodes with temperature sensing features.
Dave Rosa, CEO of NeuroOne, comments, “NeuroOne is committed to protecting our groundbreaking electrode technology with respect to device claims and proprietary manufacturing processes. With a plethora of patent applications both in the U.S. and overseas relating to procedures in epilepsy, Parkinson’s disease, chronic back pain and drug/gene delivery, we believe the Company is well positioned to impact a number of key neurological conditions with patent-protected novel electrodes. We look forward to continued success with our patent applications.”
LETTER TO SHAREHOLDERS
January 2022 Dear fellow shareholders,
In fiscal 2022 we made terrific strides in advancing our game-changing cortical, strip, grid and sEEG electrode technology for broad diagnostic and therapeutic applications. Today, NeuroOne provides a full line of electrode technology to address an estimated worldwide market of $100 million for patients requiring diagnostic brain mapping procedures. Our focus remains on patients suffering from epilepsy, chronic back pain, and Parkinson’s disease.
NeuroOne’s robust product suite has recently expanded beyond our first disruptive product introduction, the Evo® Cortical Electrode, to include our second FDA 510(k) cleared product, the Evo® sEEG Depth Electrode system, which is ready for commercial launch in the current calendar quarter. During 2022 we also made substantial development progress with our first combination system which includes both diagnostic and ablation capabilities.
The purpose of this letter is to share with you fiscal year 2022 and subsequent key highlights along with multiple exciting catalysts for NeuroOne in fiscal 2023.
Fiscal Year 2022 and Subsequent Highlights
Clearly our most exciting and important accomplishment as a company to date was receiving U.S. Food and Drug Administration (FDA) 510(k) clearance for our Evo® sEEG product portfolio. FDA 510(k) clearance enables us to market the Evo sEEG (stereoelectroencephalography) Electrode technology for temporary (less than 30 days) use with recording, monitoring, and stimulation equipment for the recording, monitoring, and stimulation of electrical signals at the subsurface level of the brain. With this milestone, the full diagnostic functionality of our EVO sEEG System is complete.
The first commercial order of Evo sEEG Electrodes for temporary (less than 30 days) use was shipped to Zimmer Biomet, another major achievement for our Company. Our manufacturing ramp and commercialization strategies are in place for near-term market introduction in collaboration with our distribution and development partner Zimmer Biomet (NYSE: ZBH).
Significant progress was made in the development of our OneRFTM therapeutic ablation electrode system. Milestones completed include i) testing of hardware and software prototypes for the accompanying RF generator, ii) the design and testing of the OneRF system accessories, and iii) a second successfulanimal feasibility study at the Mayo Clinic. Designed to both record brain activity and ablate nervous tissue using the same electrode, our system offers the potential for a safer and less expensive combination electrode, intended to improve patient outcomes, reduce procedures and overall treatment cost. This system will potentially be our first therapeutic device, representing the next major phase in our Company’s development.
We completed initial testing and advanced the development of electrodes for chronic stimulation and recording. Our initial target is the spinal cord stimulation market, a $3 billion market in the U.S. alone. We are designing our devices to utilize percutaneous delivery systems (non- surgical placements) that require less battery energy and expanded tissue coverage as compared to standard electrodes placed percutaneously1. Since our electrodes are intended to be implanted for long-term use, theyhave advanced insulation against fluid permeation and greater durability than devices intended for less than 30 days use. Prominent key opinion leaders joined our new Physician Advisory Board to help guide our development of both the electrode and device delivery system(s).
We increased our financial runway and maintain capital resources to support upcoming commercial and development catalysts. In August 2022 we received an accelerated $3.5 million payment from Zimmer Biomet related to certain milestone events, as part of an amendment to our distribution and development agreement. Earlier in fiscal year 2022 we completed a public offering, raising gross proceeds of $13.4 million.
Additional partners were qualified for manufacturing. With an expanded supply chain, we are well- equipped to meet increased product demand with the market launch of the Evo sEEG.
We bolstered our management team by hiring key positions in Research and Development and Quality Control. Our leadership team holds deep expertise in thin film electrode technology research and development, marketing, finance, quality control, regulatory affairs, and business development. The Company also benefits from a world-class board of directors and esteemed scientific and physician advisory boards.
1 North RB, Kidd DH, Olin JC, Sieracki JM. Spinal cord stimulation electrode design: prospective, randomized, controlled trial comparing percutaneous and laminectomy electrodes-part I: technical outcomes. Neurosurgery. Aug 2002;51(2):381-9; discussion 389-90.
NeuroOne joined the University of Minnesota in a National Institutes of Health (NIH) grant submission. NIH funding would support our joint development of a chronic cortical electrode capable of both recording and stimulation. We believe this device will provide new opportunities for clinical studies in many areas, including chronic pain, substance use disorder, depression, obsessive compulsive disorder, and other mental health conditions.
Our corporate and scientific teams presented and promoted NeuroOne at numerous high-profile events in the U.S. and overseas. Our data was presented to the scientific community at the Neuroelectronic Interfaces Gordon Research Conference, Congress of Neurological Surgeons, Society for Neuroscience, and American Epilepsy Society meetings. We exhibited our Evo electrode product family with Zimmer Biomet at the Congress of Neurological Surgeons annual meeting and the American Epilepsy Society annual meeting. The Evo sEEG implantation accuracy study was featured in a podium presentation at the Biennial Meeting of the World Society for Stereotactic &Functional Neurosurgery, held in South Korea. Our full team participated in a Nasdaq Stock Market Closing Bell ceremony to celebrate our Evo sEEG FDA 510(k) clearance milestone.Fiscal Year 2023 Potential Catalysts
Commercial launch of Evo sEEG Electrodes. We expect to begin the commercial launch of our Evo sEEG electrodes with Zimmer Biomet in the first calendar quarter of 2023. We have already shipped the first commercial order and will continue to build up inventory to meet product forecasts and additional orders in house.
Continuing ablation electrode development. OneRF is on track for submission of a 510(k) application to the FDA in the second quarter of calendar year 2023.
Continuing spinal cord stimulation (SCS) electrode development. In 2023, we will continue to refine our chronic spinal cord electrode design based on customer feedback and conduct additional pre- clinical bench and/or animal tests to further validate our value proposition.
Exploration of additional partnerships. We believe there may be opportunities to establish mutually beneficial relationships with companies that could leverage our core technology. Our technology enables, complements, and/or competes with a number of companies that are in the market or attempting to enter the market with diagnostic or therapeutic technologies to treat brain related disorders. In addition, our technology may have application in cardiovascular, orthopedic, and pain related indications that could benefit from a high-fidelity thin film electrode product that can provide stimulation and/or ablation therapies.
Exploration of new indications. As mentioned previously, we are excited about working with the University of Minnesota to develop an electrode that could be used as part of a closed loop cortical system that has the potential to provide both recording and therapeutic stimulation for multiple indications, one of which includes mental health conditions, an exciting market that is exploring more effective treatments in addition to pharmacological care.
In closing, the NeuroOne team made great progress in fiscal 2022 on multiple fronts including commercialization, product development, and financing. We are in a strong position to continue executing meaningful advances in electrode technology for a variety of neurological applications.
Evo® Cortical ElectrodeNeuroOne offers a breakthrough thin-film electrode for the diagnosis of various neurological conditions. Evo’s high- definition, minimally invasive technology delivers major advantages over the limitations of legacy silicone-based electrodes, hampered by the lack of innovation and progress in electrode technology, that are still widely used today.o Over 7 times thinner and 8 times lighter than comparable silicone electrodes used in legacy products. o Flexibility, thinness, and reduced weight facilitates potential for minimally invasive placement.o Reduced inflammation as compared to silicon-based legacy electrodes based on published testing by Mayo.Evo cortical electrode technology has received 510(k) clearance from the FDA for recording, monitoring, and stimulating brain tissue for up to 30 days.
Evo® sEEG ElectrodeThe Evo sEEG electrode technology offers stereoelectrocencephalography recording, spinal cord stimulation, brain stimulation and ablation solutions. The first clinical case using the Evo sEEG electrode was recently performed by Dr. Robert Gross at Emory University for intraoperative brain mapping at the subsurface level of the brain.The sEEG electrode has received FDA 510(k) clearance from the FDA for use of less than 24 hours. A 510(k) for Evo sEEG electrode technology for up to 30 day use has been submitted to the FDA.
Brain Monitoring – Understanding What Allows Us To Sense, Move, Think And Feel
Neurons
86 BILLION NEURONS
Neurons communicate through electrical and chemical signals. The specific properties of the neurons composing a brain area and their connections with neurons in other brain areas, define the function of a brain area (e.g. language, vision, movement).
Monitoring Neural Activity
THEY CAN RECORD ELECTRICAL SIGNALS
There are different ways to record and monitor neural activity. Their solution is to provide electrodes that are placed on top of or within the brain and capture the activity of a group of neurons located underneath/around each contact. The signals recorded are called intracranial electroencephalogram (iEEG) or electrocorticography (ECoG) signals. The shape, amplitude and frequency of these electrical signals provide a readout of the activity of that brain area.
Monitoring Neurological Disorders
Neurological diseases may be associated with disturbances in neural activity and connectivity between brain areas. The changes in the shape, amplitude and frequency of recorded electrical signals may be used to identify areas with altered activity.
Epilepsy
Epilepsy is the disease associated with spontaneously recurring seizures. A seizure is a sudden, uncontrolled electrical disturbance in the brain. It can cause changes in behavior, movements or feelings, and in levels of consciousness. There are different types of seizures and their characterization and classification helps guide the treatment.
There are more than twenty seven FDA-approved drugs for the treatment of seizures. However, in ~1/3 of the patient’s medication fails to control their seizures. These patients are candidates for surgical options.
Evo® Cortical Electrode
Cortical or subdural electrodes are used in electrocorticography (ECoG) or intracranial electroencephalography (iEEG) surgeries to monitor, record and stimulate the surface of the brain for up to 30 days. The company’s Evo cortical electrode portfolio consists of various contact configurations of strip and grid electrodes. (Rx only)
The Evo Advantage
Decreased Immunological Response – The Evo Electrode is over 7 times thinner than a silicone electrode. The flexibility and reduced volume should reduce pain and edema.
The Evo’s polyimide substrate has properties like increased flexibility, reduced volume, and decreased immunological response, which should reduce signal artifacts.
Single Tail Design – The single thin tail design allows the implanted electrode tail to be tunneled through one incision which should reduce infection risk and procedure time.
Reduced Cable Management – A disposable cable assembly is sent with each Evo Electrode as an electrode kit, removing the need to source the correct cables for each electrode being used in surgery. Also, hospital resources are freed from the management of sterilizing and storing individual electrode cable assemblies.
How NeuroOne’s Thin Film Electrode Technology is Different
In comparison to currently available technologies, our electrodes are manufactured with polyimide thin film. Our electrodes are designed to reduce trauma to the brain by allowing a less invasive implant due to the flexibility, thinness and reduced weight of the electrode.
Furthermore, the potential to significantly increase the resolution of brain recordings may enable the usage of powerful computing techniques, such as machine learning and artificial intelligence.
Caution: US Federal law restricts this device to sell by or on the order of a physician
Two FDA-Cleared Devices and Counting
Are you beginning to understand that NeuroOne is not just “another” MedTech company? In fact, their Evo Cortical and sEEG Electrodes are both FDA approved!
What they are doing right now has incredible implications for the future of the medical industry.
So much so that the technologies below could be commonplace and in wide use across the globe.
NeuroOne® Receives FDA 510(k) Clearance to Market its Evo® sEEG System for Less than 30 Day Use
Company focused on manufacturing ramp for commercialization in partnership with Zimmer Biomet
EDEN PRAIRIE, Minn., Oct. 25, 2022 /PRNewswire/ — NeuroOne Medical Technologies Corporation (Nasdaq: NMTC) (NeuroOne or the Company), a medical technology company focused on improving surgical care options and outcomes for patients suffering from neurological disorders, today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance to market its Evo sEEG Electrode technology for temporary (less than 30 days) use with recording, monitoring, and stimulation equipment for the recording, monitoring, and stimulation of electrical signals at the subsurface level of the brain.
The Company’s Evo Cortical and sEEG Electrodes are a portfolio of hi-definition thin film electrodes. Potential advantages include increased signal clarity and reduced noise; better tactile feedback during insertion into brain tissue; and faster order fulfillment due to an automated manufacturing process.
As previously reported, NeuroOne is also advancing a pipeline of therapeutic electrode technologies for brain tissue ablation and chronic stimulation use for DBS (deep brain stimulation) and spinal cord stimulation for chronic back pain. These therapeutic electrode technologies represent addressable markets valued between $500 million and $6 billion.
MAJOR CATALYSTS
Disruptive next-generation diagnostic electrodes advancing a new era in neuroscience; foundational technology initially developed in collaboration with Mayo Clinic, a shareholder of the Company.
Strategic partnership with Zimmer Biomet (NYSE:ZBH, ~$27B mkt cap) to exclusively commercialize and distribute EVO® diagnostic electrodes; accelerated payment of $3.5 million received in August 2022.
Potential to penetrate large disease populations including epilepsy, Parkinson’s disease, and spinal cord stimulation, with total addressable markets of $1+ billion, $5+ billion, and $10+ billion, respectively.
Multi-billion market opportunity for combination devices; potential for technology adaptation and entry into AI and machine learning markets.
Platform technology with licensing potential for applications in urinary incontinence, pain management, hypertension, depression, and other related neurological disorders.
Ample capital resources to support upcoming commercial and development catalysts including the commercial launch of the Evo sEEG diagnostic line, and further development of OneRF and a thin-film-based SCS electrode system.
Leadership with deep expertise in medical device technology, marketing, and business development; world-class board of directors; esteemed scientific and physician advisory boards.
NeuroOne® Announces $3.5 Million Accelerated Milestone Payment from Zimmer Biomet for Evo® sEEG Electrode
Amendment provides Zimmer Biomet with 350,000 warrants with exercise price of $3.00 per share
EDEN PRAIRIE, Minn., Aug. 3, 2022 /PRNewswire/ — NeuroOne Medical Technologies Corporation (NASDAQ: NMTC) (“NeuroOne” or the “Company”), a medical technology company focused on improving surgical care options and outcomes for patients suffering from neurological disorders, today announced that the Company entered into an amendment to its Exclusive Development and Distribution Agreement with Zimmer Biomet, Inc. (“Zimmer”) that will provide the Company with a $3.5 million accelerated payment within 10 business days which relates to certain milestone payments. In addition, Zimmer Biomet will receive a Warrant to purchase 350,000 shares of the Company’s common stock, with an exercise price of $3.00 per share.
Dave Rosa, Chief Executive Officer of NeuroOne, states, “I want to thank Zimmer for all their support to date and their confidence in our business, technology and future endeavors. This agreement accomplishes multiple objectives for NeuroOne, most importantly by providing additional capital to our balance sheet in the short-term without the need for a highly dilutive financing, and further reinforcing our ongoing partnership with Zimmer.”
Brian Hatcher, President of the Trauma, CMFT, Foot and Ankle Division of Zimmer said, “We look forward to continuing the relationship with NeuroOne as we advance our mission to alleviate pain and improve the quality of life for people around the world.” Under the Exclusive Development and Distribution Agreement signed by both parties in July 2020, Zimmer Biomet has exclusive global distribution rights to distribute the Company’s Cortical and sEEG diagnostic electrode technology.
NeuroOne® Successfully Completes Feasibility Study with its OneRF™ Ablation System
Animal study completed under the guidance of Dr. Jamie Van Gompel at the Mayo Clinic in Rochester, MN
Company on track to submit OneRF 510(k) application to the FDA in the second quarter of calendar year 2023
EDEN PRAIRIE, Minn., Dec. 6, 2022 /PRNewswire/ — NeuroOne Medical Technologies Corporation (Nasdaq: NMTC) (NeuroOne or the Company), a medical technology company focused on improving surgical care options and outcomes for patients suffering from neurological disorders, today announced that it has successfully completed a feasibility study with its OneRF™ ablation system, a developing technology that utilizes existing implanted sEEG diagnostic electrodes for brain tissue lesioning.
The study evaluated the Company’s new RF ablation system in an animal model. The study used NeuroOne’s FDA cleared sEEG electrodes combined with a proprietary RF generator and a unique temperature control accessory that monitors and maintains the temperature at which the ablation is performed. This allows clinicians to set temperature and time for each ablation. Dr. Van Gompel and his team implanted five sEEG electrodes, performed electrophysiological recordings, and then completed a total of ten RF ablations using different settings for temperature and time. All ablations were confirmed by an MRI scan.
“This technology potentially represents a major improvement in the field, as it is the first known sEEG-guided RF system to monitor and adjust settings based on temperature throughout the ablation. The addition of this feature may improve the safety of the procedure. We are extremely excited regarding the continued progress with the OneRF ablation system and believe it could have a significant impact in setting a new gold standard for these procedures, if successful. We look forward to the FDA submission of the device in the second calendar quarter of 2023.” said Dave Rosa, CEO of NeuroOne.
As previously reported, NeuroOne is also advancing a pipeline of therapeutic electrode technologies for chronic stimulation use for DBS (deep brain stimulation) and spinal cord stimulation for chronic back pain. These therapeutic electrode technologies represent addressable markets valued between $500 million and $6 billion.
Mr. Rosa is an entrepreneur with three decades of experience in the medical device industry spanning a variety of technologies and products. In addition to CEO roles with early-stage medical device companies, Mr. Rosa’s background also includes senior roles with C.R. Bard Inc., Boston Scientific Inc., and St. Jude Medical, where his responsibilities included marketing, product development and business development. He has been named as an inventor on multiple medical device patents, serves on seven corporate boards, and has raised $200M in the capital markets. Mr. Rosa holds an MBA from Duquesne University and a BS in Commerce and Engineering from Drexel University.
RON MCCLURG
Chief Financial Officer
Mr. McClurg has over 30 years of financial leadership experience with private and public companies. Prior to joining NeuroOne, Mr. McClurg was VP – Finance & Administration and Chief Financial Officer of Incisive Surgical, Inc., a privately-held medical device manufacturer, and Chief Financial Officer and Treasurer of Wavecrest Corporation, a privately-held manufacturer of electronic test instruments for the semiconductor industry. Mr. McClurg also served as Chief Financial Officer for several publicly-held companies, including Video Sentry Corporation, Insignia Systems, Inc., and Orthomet, Inc. Currently, he serves as a director for a privately held company. He began his career in public accounting with Ernst & Young, where he earned his CPA certificate. He holds a Bachelor of Business Administration degree in accounting from the University of Wisconsin – Eau Claire.
MARK CHRISTIANSON
Co-Founder, Business Development Director, Medical Sales Liaison
In excess of 15 years of executive sales, sales management, marketing, and project management experience with development stage companies. Prior to NeuroOne, Mr. Christianson held the positions of North American Sales Manager for Cortec Corporation, a manufacturer of specialty chemical products, and Regional Sales Manager for PMT Corporation, a leading manufacturer of products for neurosurgery, orthopedics and plastic surgery. He holds an accounting degree from Augsburg College.
STEVE MERTENS
Chief Technology Officer
Prior to joining NeuroOne, Mertens was Sr. Vice President of R&D and Operations at Nuvaira, a privately held lung denervation company developing minimally invasive products for obstructive lung diseases. Before that, Mertens was a Senior Vice President of Research and Development for Boston Scientific, where he guided a wide range of technologies through product development for the cardiology, electrophysiology, and peripheral vascular markets.
Mertens began his medical device career working in engineering, quality control, and manufacturing roles at SciMed Life Sciences. Mertens holds a Bachelor of Science degree in Chemical Engineering from the University of Minnesota and a master’s degree in Business Administration from the University of St. Thomas.
CAMILO DIAZ-BOTIA
Director of Electrode Development
Dr. Camilo Diaz-Botia is a highly experienced neural engineer whose work has focused on the development of technologies for bidirectional communication with the nervous system. He has authored and co-authored multiple peer reviewed scientific articles published in journals including Journal of Neural Engineering, Neuron, and Lab-on-a-Chip.
Most recently, Dr. Diaz-Botia worked for Neuralink where he led and mentored the process engineering team to deliver projects with unique microfabrication processes. Under his direction, the team built and designed novel processes for integration of thin film neural probes with brain machine interface systems.
Dr. Diaz-Botia earned a B.S. in Electrical Engineering from Universidad Nacional de Colombia and a Ph.D. in Bioengineering from the joint program at the University of California Berkeley and the University of California San Francisco. During his graduate studies, he conducted research on microfabricated thin film neural interfaces for chronic implants developing electrocorticography arrays with silicon carbide, a material suitable for long-term performance in harsh environments, and electrode arrays for minimally invasive subcortical recordings.
CHAD WILHELMY
Vice President of Quality Control and Regulatory Affairs
Chad Wilhelmy joined NeuroOne with 20 years of medical device experience developing, implementing, and leading quality management systems. Prior to joining NeuroOne, he held top leadership roles at HLT Medical as the Vice President of Quality and at Sunshine Heart as the Senior Director of Quality. He has driven quality strategies from early-stage development to commercial distribution with both the FDA and Notified Body. Chad earned a Bachelor of Science degree from the University of Wisconsin – Stout in Engineering Technology with an emphasis in Quality.
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THE EZ-G DEVICE REPRESENTED A $28 MILLION TRANSACTION
BCAN IS AN EARLY PLAYER IN THE AI-POWERED ADULT TOY MARKET
INSIDERS OWN OVER 64% OF THIS ONE!!
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Pull up BCAN immediately.
In the adult toy industry, AI and wearable sex toys have the potential to revolutionize the market, which is expected to be worth $62.32 billion by 2030. (9)
One company to keep an eye on in this space in the AI-power sex toy market is BYND Cannasoft Enterprises Inc. (BCAN).
This one has a few catalysts to look at:
Extremely Low Float: Less than 1.2M shares available in its public float according to Finviz.(5).
Huge Market: The global sexual wellness market is projected to be worth $125B by 2026 (2)with the sextech market expected to reach $62.32B by 2030 (1)
Intellectual Property: Positive news on patent applications could prove to be a significant catalyst in 2023.
Early-mover advantage: As an early mover in the AI-powered adult toy market, they have the potential to establish itself as a leading player in the industry, providing a competitive edge over later entrants. (1)
Strong Insider Ownership: Insiders own over 64% of the shares as of 3/2/2023 according to Finviz.com.(5)
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Overall, BYND Cannasoft Enterprises Inc. (NASDAQ:BCAN) positive catalysts, such as its potential for growth and low public float, make it an attractive option for those looking to take advantage of swings with significant potential.
Maybe that’s why BYND Cannasoft Enterprises Inc. (NASDAQ:BCAN) insiders are holding onto so many shares according to Finviz. (5)
Strong insider ownership can be an indication of a company’s health and long-term potential. When insiders own a significant percentage of a company’s shares, they have a vested interest in the company’s success, which can align their interests with those of other shareholders.
High insider ownership typically signals that insiders believe in the company’s future prospects and have confidence in its management team.
BYND Cannasoft Enterprises Inc. (BCAN) has over 64% insider ownership,(5) which is a strong indication of confidence in the company’s future prospects.
This level of insider ownership could be a sign that the management team has a significant stake in the company’s success. When insiders own a large percentage of a company’s shares, it can also indicate that they are committed to the company for the long term, as they have a significant financial stake in its future performance.
The market often views high insider ownership as a positive signal, as it indicates that insiders are financially interested in the company’s success.
This can also provide shareholders with greater transparency into the company’s operations and decision-making processes, as insiders are more likely to share information with shareholders who have a vested interest in the company’s success.
On January 17, 2023, BYND Cannasoft Enterprises Inc. (Nasdaq: BCAN) (CSE: BYND) announced that in addition to the US Provisional Patent Application with serial number 63/297,009 that was filed on January 6, 2022, covering the monitoring and controlling aspects of its EZ-G device, the company filed a full-scale PCT application on January 5, 2023, under serial number PCT/IL2023/050016. (1).
The PCT application is based on BYND Cannasoft’s prototype of the EZ-G device that is currently under development and its operational aspects as a learning adult device. The PCT application further claims priority from the US Provisional application and covers an adult device with a structure and one or more moving and vibrating elements. (1)
In addition to potentially treating annoying phenomena in the female reproductive system, the EZ-G device includes technological advancements as a sex toy with a more realistic experience. The EZ-G device prototype uses sensors like a pressure sensor, temperature sensor, conductivity sensor, and heart rate sensor to determine what specifically enhances the users’ pleasure.
The EZ-G device uses artificial intelligence (AI) to transmit and receive data from the device’s sensorson conditions of the user’s sexual organs, such as moisture levels and pressure variations due to muscle contraction. The EZ-G prototype includes a Bluetooth component for controlling the adult device via an app installed on a smartphone or other portable device to collect user information about preferences and generate custom programs.
The data collected from the sensors is uploaded to the secured cloud, where it is combined with other antonymic user preferences, including the actual duration of operation of the adult device, lubrication level, and the ideal vibration level.
This information optimizes the operation of the device to satisfy the user sexually. The EZ-G device uses the collected secure data to learn the users’ responses and improve its operation to bring the user sexual satisfaction.
Wearable tech has seen tremendous growth in recent years. When most people think of wearables, they think of fitness trackers and smartwatches, but there is also an emerging trend in wearable sex toys.
The excitement of a sex toy and the thrill of clandestine public stimulation have contributed to this trend. Cannasoft intends to take advantage of the growth in the sextech market, which is expected to reach $62.32B by 2030.
According to Forbes, companies are working to innovate products that have an intelligent response to sexual activity to take advantage of this expected growth. (1).
Yftah Ben Yaackov, CEO and Director of BYND Cannasoft said
“The EZ-G device has evolved to provide treatment relief from sexual and mental problems, including the ability to have intercourse as it relates to anxiety and physical pain. The device is capable of enhancing sexual pleasure and reducing sexual pain by dispensing low concentrations of C-B-D oil lubricant in a controlled manner. It could be configured to use disposable capsules that include the C-B-D lubricant, which could be dispensed in accordance with data collected by the sensors. The sale of the disposable capsules containing the C-B-D lubricant would provide BYND Cannasoft with a revenue model much like the razor and the razor blade.” (1)
Sexual wellness is an underfunded industry that is set to explode as sexual taboos continue to lift. Sextech — which has evolved from a male-centric vice industry to a female-centric wellness business — is here to enhance everything from pleasure to medicine.
Key Takeaways: (13)
Consumer demand is surging: There were 36m+ connected sextech devices in use globally last year, representing 87% YoY growth.
The market for connected devices alone is expected to more than double over the next 5 years to reach $9B.
Sextech goes far beyond toys. It’s set to disrupt all areas of the sexual wellness space, from health to education.
The wider industry of sexual wellness, which is now worth $62B, is forecast to exceed $125B by 2026.
The sex-positive movement is driving change and lifting taboos; industry veterans believe we are on the cusp of a surge in funding.
The US sextech market is still largely offline, leading to attractive ecommerce opportunities.
Tel Aviv Listed Together Pharma’s Subsidiary Globus Pharma Ltd and BYND Cannasoft Enterprises’ Subsidiary Sign First Commercial Agreement for Medical Cannabis Products
VANCOUVER, British Columbia and ASHKELON, Israel, Oct. 27, 2022 (GLOBE NEWSWIRE) — BYND Cannasoft Enterprises Inc. (NASDAQ: BCAN) (CSE: BYND) (“BYND Cannasoft” or the “Company”) announced today its Israeli subsidiary signed an agreement with Globus Pharma LTD, a subsidiary of Israeli-based Together Pharma Ltd (TA: TGTR), for the cultivation, production, and distribution of medical cannabis products that are expected to generate significant revenues for the company before costs of manufacturing and distribution fees. The manufacturing of the medical cannabis products will adhere to BYND Cannasoft’s instructions and stringent standards. These products will be exclusively marketed and distributed by BYND Cannasoft in Israel through Globus Pharma. Due to their safety profile and strong therapeutic efficacy, the products are based on strains developed by Together Pharma and selected exclusively by BYND Cannasoft.
BYND Cannasoft’s agreement with Together Pharma will take effect upon the issuance of a full license by the Medical Cannabis Unit at the Ministry of Health of the State of Israel (the “MCU”). While BYND Cannasoft has received initial approval from the MCU to engage in medical cannabis without direct contact with the substance, there is no guarantee that it will receive a full license.
Israel has emerged as one of the leading countries for the consumption of medical cannabis in the world. According to Israel’s Health Ministry, more than 100,000 Israeli citizens have medical cannabis permits, a 1,600 percent increase over the past decade. Regulations governing the research, cultivation, processing, distribution, and sale of cannabis remain extremely strict. Israel’s Health Ministry estimated that medical cannabis consumption increased to 43 metric tons in 2021, from 28.5 million in 2020. According to Prohibition Partners, an industry analysis firm, Israel’s medicinal cannabis market had an approximate value of $264 million in 2021, roughly $7 million less than all of Europe’s.
Yftah Ben Yaackov, CEO and Director of BYND, said, “The medical cannabis arena is being commercialized rapidly in Israel, and we expect to see more development in Israel and worldwide. Many of today’s decision-makers in the pharmaceutical industry and the medical community understand the benefits produced by specific cannabis strains.” Mr. Yaackov continued, “The products BYND Cannasoft plans to bring to market may provide additional treatment options and respond to the unmet medical needs of patients. After an in-depth and lengthy review, we partnered with Together Pharma because we knew we could have a tremendous impact on the community. The high-quality medical cannabis Together Pharma produces in accordance with BYND Cannasoft’s high quality and safety standards – will help us realize our goal of improving patients’ lives.”
This system gives the growers a deep insight into all aspects of managing a cann-a-bis farm and cann-a-bis distribution from the amounts of fertilizer right to managing delivery revenue – all with a few clicks. The company’s powerful BI tools allow growers to receive information in real-time, in great resolution to allow optimal efficiency and profit.
The Company’s plans include the construction of 4 state of the art greenhouses, housing approximately 2.5 acres of total growing area.
BYND Cannasoft Enterprises Inc. estimates that once fully operational, its Cann-a-bis farm facility will be able to produce 7,500kg of raw cann-a-bis each year.
BYND also intends to work with strategic partners to develop and market new, proprietary cann-a-bis infused products for sale throughout Israel and for export.
The company operates on 3 parallel levels as part of its plans to enter the market for growing and selling medical cann-a-bis:
The company is working to transfer the initial permit for the cultivation and multiplication of medical cann-a-bis according to the partnership agreement with the Bzizinsky family, after its transfer, the company will operate for the planning and construction of a growing facility in Moshav Kochav Michael.
The company has completed the planning and placement of an internal breeding facility and has applied for a growing and breeding license for this facility.
The company has submitted an application for a license to trade in medical cann-a-bis “without contact with the substance” known as a constructive license, after receiving it the company will be able to implement agreements it has signed with various growers for marketing and sales of the company’s private label.
BCAN broke the news in September that they have signed a share purchase agreement to acquire 100% ownership of Zigi Carmel Initiatives & Investments Ltd. (ZC) which holds the patent pending intellectual property for the EZ-G device. Under the terms of the share purchase agreement, BCAN will issue to ZC’s owner 7,920,000 common shares and pay $100K to cover legal expenses.
The EZ-G device represented a $28 million transaction that Ben Yaackov says will add value to BYND as it seeks regulatory approval and patent registration.
The EZ-G device uses proprietary software (provisional application) to regulate the flow of low-concentration CBD oils into the soft tissues of the female reproductive system to treat candida, dryness, scars and other health issues.
“This, together with our great development in the software field and the preparations of obtaining the license to practice medical cannabis, makes the last two years a period of great prosperity and success,” he adds. “We are confident that it will bring significant value for the Company in the upcoming year.”
Wrapping up 2022 and moving into 2023, Ben Yaackov says he expects to see continued progress in the Company’s software development and sales expansion. Additionally, BYND is in the final stage of obtaining a license to engage in the sale of medical cannabis without connecting with the substance.
“This is a special license that few have in Israel. It allows you to establish products in the medical cannabis field, a label of your own, through an existing grower that has the license to grow medical cannabis in Israel,” he explains. “That will bring us another revenue from the side of selling medical cannabis products, and above all that, I believe that we will significantly advance the new project and finish the patent registration and put other necessary regulations and build a prototype until the end of the fourth quarter of 2023.”
CLIENTS
BYND CANNASOFT ENTERPRISES INC. SIGNS AGREEMENT FOR THE ACQUISITION OF ISRAELI-BASED ZIGI CARMEL INITIATIVES & INVESTMENTS LTD. IN A SHARE SWAP AGREEMENT VALUED AT US $28MN
VANCOUVER, British Columbia, Sept. 18, 2022 (GLOBE NEWSWIRE) — BYND Cannasoft Enterprises Inc. (NASDAQ: BCAN) (CSE: BYND) (“BYND” or the “Company”) announced today that it has signed a share purchase agreement to acquire 100% ownership of Zigi Carmel Initiatives & Investments Ltd. (“ZC”) which holds the patent pending intellectual property for a therapeutic device (the “EZ-G device”) that uses low concentrations of CB oils, such as hemp seed oil and other natural oils, to treat certain women’s health issues…
The EZ-G device is a unique, patent-pending device that, combined with proprietary software (provisional application), regulates the flow of low-concentration CB oils into the soft tissues of the female reproductive system. According to research conducted across the globe, treatment with low-concentration CB oils can relieve candida, dryness, scars, and many other female health issues.
BYND intends to pursue the final registration of the patent and establish a marketing and sales system for the EZ-G device.The Company’s ‘Go to Market’ strategic plan is based on combined B2B and B2C sales. Numerous studies have shown CB interacts with the endocann-a-binoid system, a master regulatory system with receptors all around the body. By activating these receptors, CB can have health benefits that help make sex more approachable and pleasurable by reducing stress, enhancing one’s mood, promoting body comfort, and treating vaginal issues. According to the Brightfield Group, a cann-a-bis industry data research firm, sales of CB products could reach $11Bn by 2027. A recent Zion Market Research study indicates the market size of global gynecology devices was worth $10.8Bn in 2021 and is estimated to exceed $19.5Bn by 2028 with a compound annual growth rate (CAGR) of approximately 10.3 percent.
…
Yftah Ben Yaackov, CEO and a Director of BYND, said, “From the moment we complete the purchase of ZC, we plan to hit the ground running by initially securing any required regulatory approval from the appropriate authorities. We will continue to pursue the registration of the patent, which contains over 100 claims, prototype production and start validation tests, and contract with suppliers for the production of the device and the oils used in the EZ-G device.
The demand for a unique device combined with software, such as the EZ-G device, stems from the increasing occurrence of chronic conditions and the rising adoption of self-health management. Using a device at home is a very cost-effective treatment, and it opens up a vast channel for millions of women.” Mr. Ben Yaackov continued, “We hope to use the knowledge we have gained in the medical cann-a-bis field to significantly improve the quality of life of women suffering from symptoms such as those mentioned above.”
BYND CANNASOFT ENTERPRISES INC. LAUNCHES BETA TEST FOR MANAGING FARMS CRM PLATFORM AT ISRAEL’S WEIZMANN INSTITUTE OF SCIENCE
VANCOUVER, British Columbia, Sept. 28, 2022 (GLOBE NEWSWIRE) — BYND Cannasoft Enterprises Inc. (NASDAQ: BCAN) (CSE: BYND) (“BYND” or the “Company”) announced that its subsidiary BYND – Beyond Solutions Ltd. has signed an agreement with the Weizmann Institute of Science for the use of its proprietary software. …
Yftah Ben Yaackov, CEO and a Director of BYND, said, “This is an extremely important step in the development of BYND Cannasoft Enterprises medical cann-a-bis software since the Weizmann Institute has many greenhouses of various types that can cover all the development possibilities of the software in the coming year…”
MANAGEMENT
MOTI MARAM
President and Director
In 1986, together with a partner company, he founded a computer company that mainly provided services to EXATEC-compliant IBM AS 400 computers and subsequently sales and service to the first PCs in the world. After identifying a need for CRM and ERP software, Maram and his partner, Avner Tal, established a software company that manufactures CRM and ERP management software called BENEFIT in 2000.
HAROLD WOLKIN
Harold is a retired, former Investment Banker and Financial Analyst with over 40 years of business experience. An advisor to Chief Executive Officers and Board of Directors of both public and private companies. Strong financial expertise, a Chartered Financial Analyst (CFA) and member of the Institute of Corporate Directors.
YFTAH BEN YAACKOV
CEO and Director
Professional lawyer since 2004. Specialized in real estate related issues on all aspects of it including real estate corporations, complex sales transactions, real estate unions, real estate taxation. Notary License holder since 2014. Managed large projects of tens of thousands Square meters for a total amount of above 400 million NIS. At the last 5 years yftah has assembled the business activity of 2 of the largest medical cannabis company’s in Israel and has an enormous experience and knowledge in this field.
DR. STEFÁNIA SZABÓ
Director
Stefánia is the Vice President of Pace Law Firm and Director of International Relations at Pace Global Advantage in Toronto, Canada. She is a former diplomat, a charismatic government services, management and public relations professional with 25 years of progressive experience. She is an international lawyer by profession, and serves as member of the executive committee of the Canada-Israel Chamber of Commerce.
AVNER TAL
VP Sales & Marketing, CTO and Director
Technology director of Beyond Solution Company. I studied electronics and control. I served in the Navy and I was in the team that implemented and developed the technology and even carried out the experiments that included “smart” missiles. Joined Moti to established a computer company that supported Exatech computers and its innovative network.
NEWS
GlobeNewswire•last monthISRAELI CANNABIS TECHNOLOGY COMPANY BYND CANNASOFT ENTERPRISES FILES US PROVISIONAL PATENT APPLICATION AND FULL SCALE PCT APPLICATION FOR ITS EZ-G DEVICEThe new full scale PCT application for the EZ-G device, comprised of a structure and one or more moving and vibrating elements, will utilize Artificial Intelligence (AI) to send data about learned sexual preferences to the cloud to heighten arousal, and intimacyASHKELON, Israel and VANCOUVER, British Columbia, Jan. 17, 2023 (GLOBE NEWSWIRE) — BYND Cannasoft Enterprises Inc. (Nasdaq: BCAN) (CSE: BYND) (“BYND Cannasoft” or the “Company”) announced today that in addition to the US Provisional Pate
GlobeNewswire•3 months agoCEO’S LETTER TO SHAREHOLDERSASHKELON, Israel and VANCOUVER, British Columbia, Dec. 15, 2022 (GLOBE NEWSWIRE) — BYND Cannasoft Enterprises Inc. (Nasdaq: BCAN) (C.S.E.: BYND) (“BYND Cannasoft” or the “Company”) today issued a letter to shareholders from its Chief Executive Officer and Director, Yftah Ben Yaackov. Successful Nasdaq Uplisting On May 31, 2022, BYND Cannasoft was approved for trading on the Nasdaq Capital Market. This listing represents a significant milestone for BYND Cannasoft and enhances our ability to crea
GlobeNewswire•3 months ago$62 BILLION POTENTIAL SEX TOY MARKET COULD BE DISRUPTED BY ISRAELI CANNABIS TECHNOLOGY COMPANY BYND CANNASOFT ENTERPRISES’ PCT PATENT APPLICATIONPCT patent application could potentially cover the EZ-G device as a sex toy, as well as a double-faceted condomASHKELON, Israel and VANCOUVER, British Columbia, Dec. 07, 2022 (GLOBE NEWSWIRE) — BYND Cannasoft Enterprises Inc. (Nasdaq: BCAN) (CSE: BYND) (“BYND Cannasoft” or the “Company”) announced today it is in the advanced stages of expanding its EZ-G device’s applications into the leisure field of sex toys. In addition to potentially treating annoying phenomena in the female reproductive sys
GlobeNewswire•3 months agoISRAELI CANNABIS TECHNOLOGY COMPANY BYND CANNASOFT ENTERPRISES INC. FILES EZ-G PATENT APPLICATION TO INCLUDE DOUBLE FACETED CONDOMASHKELON, Israel and VANCOUVER, British Columbia, Dec. 01, 2022 (GLOBE NEWSWIRE) — BYND Cannasoft Enterprises Inc. (Nasdaq: BCAN) (CSE: BYND) (“BYND Cannasoft” or the “Company”) announced today the filing of a patent application for its EZ-G device to include an innovative double-faceted condom design. The double-faceted condom is designed to help treat various problems related to intimate relationships while making the sexual experience much more pleasurable for everyone involved. BYND Cannaso
GlobeNewswire•3 months ago$10.97 BILLION POTENTIAL GLOBAL CONDOM MARKET COULD BE A KEY DRIVER OF GROWTH FOR ISRAELI CANNABIS TECHNOLOGY COMPANY BYND CANNASOFT ENTERPRISESA patent pending Double-faceted condom to enhance sexual pleasure marks BYND Cannasoft’s entry in a multi-billion-dollar marketASHKELON, Israel and VANCOUVER, British Columbia, Nov. 30, 2022 (GLOBE NEWSWIRE) — BYND Cannasoft Enterprises Inc. (Nasdaq: BCAN) (CSE: BYND) (“BYND Cannasoft” or the “Company”) announced today it is aiming to enter into the global condom market, which is expected to grow to USD $10.97 billion by 2030. The company intends to offer consumers a revolutionary design for se
GlobeNewswire•3 months agoISRAELI TECHNOLOGY COMPANY BYND CANNASOFT ENTERPRISES INC. ANNOUNCES CONTRACT FOR ITS BENEFIT CRM CLOUD-BASED SOFTWARE AS A SERVICE CRM PLATFORMThe agreement marks BYND Cannasoft’s commitment to penetrating additional markets and deepening services in consumer goods companies with its legacy CRM platformASHKELON, Israel and VANCOUVER, British Columbia, Nov. 17, 2022 (GLOBE NEWSWIRE) — BYND Cannasoft Enterprises Inc. (Nasdaq: BCAN) (CSE: BYND) (“BYND Cannasoft” or the “Company”) announced today that it has signed an agreement for the provision of software services with one of Israel’s leading air conditioning companies. Under the terms
GlobeNewswire•4 months ago494% INCREASE IN ASSETS TO US$33 MILLION ISRAELI CANNABIS TECHNOLOGY COMPANY BYND CANNASOFT ENTERPRISES INC. POISED FOR GROWTHStrengthened balance sheet, increased gross margins, and reduced expenses provide increased focus on growth based on BYND Cannasoft’s CRM SaaS platform, medical cannabis, and EZ-G deviceASHKELON, Israel and VANCOUVER, British Columbia, Nov. 15, 2022 (GLOBE NEWSWIRE) — BYND Cannasoft Enterprises Inc. (Nasdaq: BCAN) (CSE: BYND) (“BYND Cannasoft” or the “Company”) announced today future plans for growth after posting a 494% increase in assets for the nine-month period ended September 30, 2022. The
GlobeNewswire•4 months agoISRAELI CANNABIS TECHNOLOGY COMPANY BYND CANNASOFT ENTERPRISES INC. ANNOUNCES THIRD QUARTER 2022 FINANCIAL RESULTSCompany reports 494% growth in 2022 assets to $33 million USD and strengthened balance sheet while increasing gross margins and reducing lossesVANCOUVER, British Columbia, Nov. 10, 2022 (GLOBE NEWSWIRE) — BYND Cannasoft Enterprises Inc. (Nasdaq: BCAN, CSE: BYND) (“BYND” or the “Company”), has released its financial results for the nine-month period ended September 30, 2022. Full versions of BYND’s unaudited consolidated interim financial statements and management discussion and analysis for the
GlobeNewswire•4 months agoISRAELI CANNABIS TECHNOLOGY COMPANY BYND CANNASOFT ENTERPRISES PROVIDES UPDATE ON INTERNATIONAL PATENT APPLICATION PROCESS FOR ITS REVOLUTIONARY EZ-G DEVICEInternational Searching Authority under the Patent Cooperation Treaty (“PCT”) provides non-binding opinion that one of the inventions comprising the EZ-G device is novel and inventiveASHKELON, Israel and VANCOUVER, British Columbia, Nov. 03, 2022 (GLOBE NEWSWIRE) — BYND Cannasoft Enterprises Inc. (NASDAQ: BCAN) (CSE: BYND) (“BYND Cannasoft” or the “Company”) announced today that as part of the PCT patent application process for the EZ-G device, an International Searching Authority (“ISA”) exami
GlobeNewswire•4 months agoTEL AVIV LISTED TOGETHER PHARMA’S SUBSIDIARY GLOBUS PHARMA LTD AND BYND CANNASOFT ENTERPRISES’ SUBSIDIARY SIGN FIRST COMMERCIAL AGREEMENT FOR MEDICAL CANNABIS PRODUCTSVANCOUVER, British Columbia and ASHKELON, Israel, Oct. 27, 2022 (GLOBE NEWSWIRE) — BYND Cannasoft Enterprises Inc. (NASDAQ: BCAN) (CSE: BYND) (“BYND Cannasoft” or the “Company”) announced today its Israeli subsidiary signed an agreement with Globus Pharma LTD, a subsidiary of Israeli-based Together Pharma Ltd (TA: TGTR), for the cultivation, production, and distribution of medical cannabis products that are expected to generate significant revenues for the company before costs of manufacturing
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IN PREPARING THIS PUBLICATION, DEDICATED INVESTORS LLC HAS RELIED UPON INFORMATION SUPPLIED BY ITS CUSTOMERS, PUBLICLY AVAILABLE INFORMATION AND PRESS RELEASES WHICH IT BELIEVES TO BE RELIABLE; HOWEVER, SUCH RELIABILITY CANNOT BE GUARANTEED. INVESTORS SHOULD NOT RELY ON THE INFORMATION CONTAINED IN THIS WEBSITE. RATHER, INVESTORS SHOULD USE THE INFORMATION CONTAINED IN THIS WEBSITE AS A STARTING POINT FOR DOING ADDITIONAL INDEPENDENT RESEARCH ON THE FEATURED COMPANIES. DEDICATED INVESTORS LLC HAS NOT BEEN COMPENSATED FOR THIS EMAIL. THE ADVERTISEMENTS IN THIS WEBSITE ARE BELIEVED TO BE RELIABLE, HOWEVER, DEDICATED INVESTORS LLC AND ITS OWNERS, AFFILIATES, SUBSIDIARIES, OFFICERS, DIRECTORS, REPRESENTATIVES AND AGENTS DISCLAIM ANY LIABILITY AS TO THE COMPLETENESS OR ACCURACY OF THE INFORMATION CONTAINED IN ANY ADVERTISEMENT AND FOR ANY OMISSIONS OF MATERIALS FACTS FROM SUCH ADVERTISEMENT. 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MORE THAN 1600 COMPANIES TRUST US TO HELP THEM STREAMLINE THEIR OPERATIONS, IMPROVE INTER-DEPARTMENTAL EFFICIENCY, AND REDUCE OPERATIONAL OVERHEAD
POWERBRIDGE TECHNOLOGIES UNVEILS PLANS TO LEVERAGE CHATGPT TECHNOLOGY FOR EARLY CHILDHOOD EDUCATION
$PBTS Our integration of #ChatGPT into AI-powered education is making exciting progress, benefiting over 400K users. This presents a significant growth opportunity to watch! Stay tuned for more updates. #AI#education#Artificial_Intelligence
We have a new Nasdaq profile that we wanted you to look at for tomorrow’s session. This is a company operating in THE hottest sectors on Wall Street right now.
Pull up PBTS right away.
PBTS is a leading provider of multi-industry technology solutions. The Company offers software and platform applications, IoT platform services and intelligent devices, supply chain platforms and interactive media services, metaverse and digital services, and cryptomining platform services and cryptocurrency asset operations.
With everyone talking about ChatGPT and AI right now, PBTS stands to gain some recognition as the operate in the Artificial Intelligence space as well as the Metaverse, Crypto and other Fintech areas.
This one saw a nice pullback today which provides a solid opportunity to research this one.
A few weeks back we saw this one run all the way up to .17 from it’s current levels, giving ANYBODY who bought in the month of January before the last two sessions a shot at some serious returns.
What may have contributed to the run is the size of the float. According to Yahoo Finance, PBTS has a float of just 88 Million. At .10, that just $8.8Mill. The day it ran to .17 it traded the float twice over. This could be a major catalyst for the company moving forward.
LOOK AT THE 3 MONTH CHART AND THE POTENTIAL FOR A SQUEEZE UNDER THE RIGHT CIRCUMSTANCES.
POWERBRIDGE TECHNOLOGIES UNVEILS PLANS TO LEVERAGE CHATGPT TECHNOLOGY FOR EARLY CHILDHOOD EDUCATION
ZHUHAI, China, Feb. 13, 2023 /PRNewswire/ — Powerbridge Technologies Co., Ltd. (Nasdaq: PBTS) (“Powerbridge” or the “Company”), a leading provider of multi-industry technology solutions, is pleased to announce its plan to integrate ChatGPT technology into the AI-powered online educational services provided by its subsidiary, Ascendent Insights Education Co., Ltd. (“AIedu”).
AIedu is a provider of AI-powered apps and online educational services focusing on guided-reading solutions, with over 20,000 reading materials and a user base of more than 400,000 young children. It serves over 4,000 nurseries and kindergartens with 40,000 educators supported by 10 operational centers and 150 city partners across China.
The integration of ChatGPT technology will enhance our services and provide a more interactive and engaging learning experience for young children. Additionally, the utilization of ChatGPT technology in our early childhood educational apps has the potential to be a game-changer by enabling engaging audio interactions, innovative online creation, and immersive virtual study tours. Our interactive and effective educational apps are expected to be popular among children.
Stewart Lor, CEO of Powerbridge Technologies, commented: “We believe that ChatGPT has the potential to bring significant transformation in the education industry. We are excited to provide a whole new education experience for young children through the use ChatGPT technology. We expect to continue driving growth for the Company and provide attractive returns for our investors.
POWERBRIDGE TECHNOLOGIES LAUNCHES WEB 3.0 CRYPTOCURRENCY ETF PLATFORM
ZHUHAI, China, Feb. 21, 2023 /PRNewswire/ — Powerbridge Technologies Co., Ltd. (Nasdaq: PBTS) (“Powerbridge” or the “Company”), a provider of multi-industry technology solutions, is pleased to announce the launch of its decentralized cryptocurrency ETF platform (“Powerbridge ETF Platform” or the “Platform”) based on the cutting-edge Web 3.0 technology.
Powerbridge ETF Platform provides a decentralized and transparent network based on Web 3.0 technology. The Platform utilizes big data analysis to select cryptocurrency index funds, reducing human bias and empowering users to manage their own assets and data without the need for third-party intermediaries. The Platform generates index fund products based on trading strategies and preferences of majority traders across a variety of cryptocurrencies. This allows users to take advantage of market trends and opportunities with a secure and convenient way to trade and manage cryptoassets.
Stewart Lor, CEO of Powerbridge Technologies commented: “We are excited with the launch of Powerbridge ETF Platform for cryptocurrencies. I believe our platform offers users a better way to trade and manage their crypto assets. We are continuing working with a network of partners to bring our Platform to market. I expect our Platform will contribute to our overall growth.”
POWERBRIDGE TECHNOLOGIES ANNOUNCES THE STRATEGIC ACQUISITION OF DTI GROUP TO EXPAND ITS OPERATIONS IN TRADE DIGITALIZATION
ZHUHAI, China, Nov 14, 2022 /PRNewswire/ — Powerbridge Technologies Co., Ltd. (Nasdaq: PBTS) (“Powerbridge” or the “Company”), a provider of multi-industry technology solutions, announces that the Company has acquired 19% stake of DTI Group Limited (“DTI”), a technology company specializing in international trade digitalization and platforms.
The acquisition is consistent with the Company’s development plan and contributes to the expansion of its operations by building a trade digitalization ecosystem. DTI is one of the leading platform developers and service providers for Digital Trading Infrastructure & Online Dispute Resolution, a global project initiated by the United Nations Conference on Trade and Development. With the strategic acquisition, Powerbridge and DTI will be working closely together to implement the United Nation’s project (the “Project”).
The objective of the Project is to enhance digital trade connectivity and operations among online cross-border trade platforms and offline trade hubs in order to empower both the established and new global trade players. The Project will also be equipped with various digital trade systems that encourage cooperation and communications among local and global players, which is designed to increase the overall efficiency of cross-border trade and e-commerce.
Stewart Lor, CEO of Powerbridge commented: “We see that the market demand for international trade digitalization is growing rapidly. We look forward to working with DTI to integrate our technology and market resources in developing and implementing the United Nation’s Project. We believe this acquisition is critical to our growth and will enhance investor value.”
NEWS
PR Newswire•9 days agoPOWERBRIDGE TECHNOLOGIES LAUNCHES WEB 3.0 CRYPTOCURRENCY ETF PLATFORMPowerbridge Technologies Co., Ltd. (Nasdaq: PBTS) (“Powerbridge” or the “Company”), a provider of multi-industry technology solutions, is pleased to announce the launch of its decentralized cryptocurrency ETF platform (“Powerbridge ETF Platform” or the “Platform”) based on the cutting-edge Web 3.0 technology.
PR Newswire•17 days agoPOWERBRIDGE TECHNOLOGIES UNVEILS PLANS TO LEVERAGE CHATGPT TECHNOLOGY FOR EARLY CHILDHOOD EDUCATIONPowerbridge Technologies Co., Ltd. (Nasdaq: PBTS) (“Powerbridge” or the “Company”), a leading provider of multi-industry technology solutions, is pleased to announce its plan to integrate ChatGPT technology into the AI-powered online educational services provided by its subsidiary, Ascendent Insights Education Co., Ltd. (“AIedu”).
PR Newswire•4 months agoPBTS ANNOUNCES RECEIPT OF NASDAQ NOTIFICATION LETTER REGARDING MINIMUM BID PRICE DEFICIENCYPowerbridge Technologies Co., Ltd. (“Powerbridge” or “the “Company”) (NASDAQ: PBTS), a provider of multi-industry technology solutions, announced that it has received a notification letter (the “Notification Letter”) from the Nasdaq Stock Market LLC (the “NASDAQ”) dated November 7, 2022, notifying the Company that it is not in compliance with the minimum bid price requirement as set forth under NASDAQ Listing Rule 5550(a)(2) for continued listing on the NASDAQ. This press release is issued pursu
PR Newswire•5 months agoPOWERBRIDGE TECHNOLOGIES ANNOUNCES SUCCESSFUL LAUNCH OF ITS SOCCER COLLECTABLE NFTS ON ALI AUCTIONPowerbridge Technologies Co., Ltd. (Nasdaq: PBTS) (“Powerbridge” or the “Company”), a provider of multi-industry technology solutions, announced that the Company has obtained an exclusive right in China through a partnership with the World Football Collection to offer a series of soccer collectable NFTs on Ali Auction.
PR Newswire•7 months agoPOWERBRIDGE TECHNOLOGIES CO., LTD. REGAINS COMPLIANCE WITH NASDAQ’S MINIMUM BID PRICE RULEPowerbridge Technologies Co., Ltd. (Nasdaq: PBTS) (“Powerbridge” or the “Company”), a provider of multi-industry technology solutions, announced that it has regained compliance with the minimum bid price requirement under the continued listing requirements of the Nasdaq Stock Market LLC (“Nasdaq”).
GlobeNewswire•11 months agoTECH MOMENTUM: CEO’S OF MQ, NEXCF, SNAP, PBTS, DRIVING REVENUE GROWTH IN FINTECH, AR, WEB 3.0, METAVERSE, AND DIGITAL TRANSFORMATIONNEW YORK, April 14, 2022 (GLOBE NEWSWIRE) — Wall Street Reporter, the trusted name in financial news since 1843, has published reports on the latest comments and insights from CEO’s of: Marqeta, Inc. (NASDAQ: MQ), NexTech AR Solutions (OTC: NEXCF) (CSE: NTAR), Snap Inc. (NYSE: SNAP) and Powerbridge Technologies (NASDAQ: PBTS). Wall Street Reporter highlights the latest comments from industry thought leaders shaping our world today, and in the decades ahead: Snap Inc. (NYSE: SNAP) CEO Evan Spieg
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OUR REPORTS/RELEASES ARE A COMMERCIAL ADVERTISEMENT AND ARE FOR GENERAL INFORMATION PURPOSES ONLY. WE ARE ENGAGED IN THE BUSINESS OF MARKETING AND ADVERTISING COMPANIES FOR MONETARY COMPENSATION. WE HAVE BEEN COMPENSATED A FEE OF TWENTY THOUSAND USD BY A THIRD PARTY, EDM MEDIA LLC FOR A ONE DAY PBTS AWARENESS CAMPAIGN. NEVER INVEST IN ANY STOCK FEATURED ON OUR SITE OR EMAILS UNLESS YOU CAN AFFORD TO LOSE YOUR ENTIRE INVESTMENT. 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DEDICATED INVESTORS LLC ENCOURAGES READERS AND INVESTORS TO SUPPLEMENT THE INFORMATION IN THESE REPORTS WITH INDEPENDENT RESEARCH AND OTHER PROFESSIONAL ADVICE. ALL INFORMATION ON FEATURED COMPANIES IS PROVIDED BY THE COMPANIES PROFILED, OR IS AVAILABLE FROM PUBLIC SOURCES AND DEDICATED INVESTORS LLC MAKES NO REPRESENTATIONS, WARRANTIES OR GUARANTEES AS TO THE ACCURACY OR COMPLETENESS OF THE DISCLOSURE BY THE PROFILED COMPANIES. NONE OF THE MATERIALS OR ADVERTISEMENTS HEREIN CONSTITUTE OFFERS OR SOLICITATIONS TO PURCHASE OR SELL SECURITIES OF THE COMPANIES PROFILED HEREIN AND ANY DECISION TO INVEST IN ANY SUCH COMPANY OR OTHER FINANCIAL DECISIONS SHOULD NOT BE MADE BASED UPON THE INFORMATION PROVIDED HEREIN. INSTEAD DEDICATED INVESTORS LLC STRONGLY URGES YOU CONDUCT A COMPLETE AND INDEPENDENT INVESTIGATION OF THE RESPECTIVE COMPANIES AND CONSIDERATION OF ALL PERTINENT RISKS. 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ANY STATEMENTS THAT EXPRESS OR INVOLVE DISCUSSIONS WITH RESPECT TO PREDICTIONS, EXPECTATIONS, BELIEFS, PLANS, PROJECTIONS, OBJECTIVES, GOALS, ASSUMPTIONS OR FUTURE EVENTS OR PERFORMANCE ARE NOT STATEMENTS OF HISTORICAL FACT MAY BE FORWARD LOOKING STATEMENTS. FORWARD LOOKING STATEMENTS ARE BASED ON EXPECTATIONS, ESTIMATES, AND PROJECTIONS AT THE TIME THE STATEMENTS ARE MADE THAT INVOLVE A NUMBER OF RISKS AND UNCERTAINTIES WHICH COULD CAUSE ACTUAL RESULTS OR EVENTS TO DIFFER MATERIALLY FROM THOSE PRESENTLY ANTICIPATED. FORWARD LOOKING STATEMENTS IN THIS ACTION MAY BE IDENTIFIED THROUGH USE OF WORDS SUCH AS PROJECTS, FORESEE, EXPECTS, WILL, ANTICIPATES, ESTIMATES, BELIEVES, UNDERSTANDS, OR THAT BY STATEMENTS INDICATING CERTAIN ACTIONS & QUOTE; MAY, COULD, OR MIGHT OCCUR. UNDERSTAND THERE IS NO GUARANTEE PAST PERFORMANCE WILL BE INDICATIVE OF FUTURE RESULTS. 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DEDICATED INVESTORS LLC IS NOT RESPONSIBLE FOR ANY CLAIMS MADE BY THE COMPANIES ADVERTISED HEREIN, NOR IS DEDICATED INVESTORS LLC RESPONSIBLE FOR ANY OTHER PROMOTIONAL FIRM, ITS PROGRAM OR ITS STRUCTURE. DEDICATED INVESTORS LLC IS NOT AFFILIATED WITH ANY EXCHANGE, ELECTRONIC QUOTATION SYSTEM, THE SECURITIES EXCHANGE COMMISSION OR FINRA.