_______
OUR NEW PROFILE IS: (NASDAQ: BSGM)
BIOSIG’S NEW PURE EP™ SUBSCRIPTION MODEL ADOPTED BY MAYO CLINIC-PHOENIX FOR WORLD-CLASS CARDIAC CARE
OVER 3,000 PROCEDURES HAVE BEEN PERFORMED USING THE PURE EP™ SYSTEM WITH MORE THAN 80 PHYSICIANS AT 21 HOSPITALS ACROSS THE UNITED STATES
SUBSTANTIAL AND GROWING IP PATENT PORTFOLIO
IN 2022 THE CEO PURCHASED OVER 200K SHARES
BIOSIG AI SCIENCES RECEIVES $2.2 MILLION IN SEED FUNDING TO ADVANCE DEVELOPMENT OF ARTIFICIAL INTELLIGENCE APPLICATIONS
__________________
GET THE INVESTOR PRESENTATION HERE
__________________________________
Hello Everyone,
We have another profile that we want you to take a look at before the week is over.
If you have been a member for a while then you will certainly remember this one.
We profiled this one last year back in early December when it was sitting under .50, exactly where it is right now. By Mid February this one tapped 1.46 for a 200% move in just 2 months. BSGM certainly has a history of making big moves on positive news.
Pull up BSGM immediately before the weekend.
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.
ACHIEVEMENTS
- 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.
INVESTMENT HIGHLIGHTS
- Disruptive and novel technology
- Our technology saves procedural time and improves workflow efficiency in an environment where the technology has not changed meaningfully in 25+ years.
- Substantial and growing global market
- Global EP market is growing by 11.2% and expected to reach $16B by 2028.
- Strong clinical data pipeline
- Published/ongoing clinical studies supporting commercialization.
- First customers are industry leaders
- World-renowned Medical Centers of Excellence.
- Flexible pricing model
- Supports recurring revenue and continuous innovation.
- Fortune 500 commercial team
- Proven track-record of generating sales growth.
- Well-protected IP portfolio
- ’59 Worldwide fundamental patents granted/allowed
BIOSIG’S NEW PURE EP™ SUBSCRIPTION MODEL ADOPTED BY MAYO CLINIC-PHOENIX FOR WORLD-CLASS CARDIAC CARE
PURE EP™ SUBSCRIBER COMMUNITY NOW INCLUDES TWO OF TOP THREE U.S. HEALTH SYSTEMS IN CARDIOLOGY: MAYO CLINIC-PHOENIX AND CLEVELAND CLINIC
Westport, CT, Nov. 02, 2023 (GLOBE NEWSWIRE) — BioSig Technologies, Inc. (NASDAQ: BSGM) (“BioSig” or the “Company”), a medical technology company committed to delivering unprecedented accuracy and precision to intracardiac signal visualization, announced today that Mayo Clinic-Phoenix—an existing user of the PURE EP™ Platform—has upgraded to the Platform’s subscription model to gain immediate access to the Company’s latest technological advancements in cardiac arrhythmia identification.
Harnessing the power of automation, PURE EP™’s latest software features debut unique algorithms that unlock signal data for electrophysiologists conducting even the most challenging ablation procedures.
- Automatic Tachycardia Characterization (ATC) alerts electrophysiologists to heart conduction patterns that may be difficult to detect with the naked eye or that might warrant further evaluation.
- Near-Field Tracking (NFT) monitors changes in the local unipolar electrogram to provide real-time tissue feedback that assists electrophysiologists as they make their final determinations between healthy and scarred tissue for lesion placement during an ablation.
“Our commitment to innovation and delivering exceptional patient care drives our ongoing collaboration with BioSig,” said Hicham El Masry, M.D., FHRS, Cardiac Electrophysiologist at Mayo Clinic-Phoenix. “The integration of PURE EP™’s advanced software features further reinforces our dedication to providing the best possible healthcare solutions for our patients. We look forward to the positive impact this partnership will have on our cardiac procedures.”
Mayo Clinic-Phoenix is ranked as the number one hospital in Arizona, according to the U.S. News and World Report. Within the specialty of cardiology, heart, and vascular surgery, the institution is ranked in the top one percent of hospitals nationwide (33 out of 4,515 hospitals).1
With Mayo Clinic-Phoenix and Cleveland Clinic now part of the PURE EP™ subscriber community, two out of the top three ranked health systems in cardiology, heart, and vascular surgery have embraced PURE EP™.2
“We are thrilled to roll out our newest, most innovative software to one of our company’s longest standing partners. As we continue building out PURE EP™’s software suite, customers will have the flexibility to purchase and add enhancements that meet their needs,” commented Gray Fleming, Chief Commercial Officer of BioSig. “By removing the burden of ownership and maintenance, we’re putting the latest PURE EP™ developments in physician’s hands as they unfold—unlocking the full potential of the electrophysiology lab.”
Leveraging full-spectrum signal data has significantly reduced ablation procedure times. Initial evidence suggested potential savings of approximately $418.20 per procedure using PURE EP™’s clear signals.3 Recent independent research by Cleveland Clinic shows PURE EP™’s unique unipolar capabilities may cut procedure times by up to 66%.4With the global cardiac ablation market set to exceed $14.5 billion by 2032,5 PURE EP™ offers substantial cost savings and efficiency gains for hospitals, improving patient outcomes through shorter procedures.
With a comprehensive suite of tools available through the subscription model, the PURE EP™ Platform can deliver the latest developments in electrophysiology to physicians as they emerge, with the flexibility to add enhancements as desired. For more information on how PURE EP™ can enhance arrhythmia identification and laboratory workflows, visit BioSig.com.
About The PURE EP™ Platform
The PURE EP™ Platform serves physicians by enabling the real-time acquisition of raw cardiac signal data—absent of unnecessary noise or interference inherent in traditional approaches. By leveraging a first-of-its-kind combination of hardware and software, the PURE EP™ Platform is designed to deliver unprecedented intracardiac signal purity that pushes the boundaries of cardiac arrhythmia identification, diagnosis, and treatment.
In a blinded clinical study recently published in the Journal of Cardiovascular Electrophysiology,5electrophysiologists rated PURE EP™ as superior to conventional systems for 75.2% of signal samples, with 87% earning a rating of equivalent or superior. Data presented at Heart Rhythm Society 2023 demonstrated the PURE EP™ Platform’s capacity to facilitate ablations in a third of the usual time, reducing procedure time and improving workflow efficiencies, without sacrificing accuracy, precision, or efficacy.
The PURE EP™ Platform is currently in a national commercial launch and an integral part of well-respected healthcare systems, including Mayo Clinic, Texas Cardiac Arrhythmia Institute, Cleveland Clinic, and Kansas City Heart Rhythm Institute.
BIOSIG ADDS FIVE NEW PATENT AWARDS TO 100+ TOTAL PATENT PORTFOLIO COVERING DIGITAL SIGNAL PROCESSING TECHNOLOGY AND AI
IP PORTFOLIO INCLUDES U.S. AND WORLDWIDE UTILITY AND DESIGN PATENTS AND PENDING APPLICATIONS IN THE U.S., EUROPE, AND ASIA-PACIFIC
Westport, CT, Nov. 01, 2023 (GLOBE NEWSWIRE) — BioSig Technologies, Inc. (NASDAQ: BSGM) (“BioSig” or the “Company”) a medical technology company committed to delivering unprecedented accuracy and precision to intracardiac signal visualization, announced today that the U.S. Patent and Trademark Office has awarded several new utility patents covering the Company’s PURE EP™ digital signal processing technology.
Kenneth Londoner, Chairman and CEO of BioSig, commented, “We are pleased to add five utility patent awards to our expanding intellectual property portfolio of more than 100 patents and patent applications in the U.S. and abroad. Our robust patent protection and well-constructed claims cover BioSig’s first mover advantage for our novel PURE EP™ Platform.”
New Patent Awards
U.S. Patent Application No. 16/543,061 was allowed on September 22, 2023 and is entitled “Systems and Methods To Display Cardiac Signals Based on a Signal Pattern.” The patent application describes and claims a computer method for viewing cardiac signals side by side and vertically stacked on top of each other as a pattern is matched to one of the cardiac signals.
U.S. Patent No. 11,737,699 granted on August 29, 2023 and is entitled “Systems and Methods for Performing Electrophysiology (EP) Signal Processing.” The patent describes and claims methods and systems for producing a clean unipolar signal.
U.S. Patent No. 11,737,701 granted on August 29, 2023 and is entitled “Methods, Systems and Media For Reconstructing Bioelectric Lead Placement.” The patent describes and claims methods and systems for reconstructing electrode placement on a patient using artificial intelligence.
U.S. Patent 11,617,529 granted on April 4, 2023 and is entitled “Apparatus and Methods for Removing a Large-Signal Voltage Offset from a Biomedical Signal.” The patent claims a method for processing an electrical signal having a large differential voltage offset.
U.S. Patent 11,617,530 granted on April 4, 2023 and is entitled “Apparatus and Methods for Removing a Large-Signal Voltage Offset from a Biomedical Signal.” The patent claims a system for the removal of noise in electrocardiogram (ECG) and intracardiac (IC) signals.
BioSig’s Total Patent Portfolio
- 35 issued and allowed utility patents
- 30 issued worldwide design patents
- 23 U.S. and foreign utility patent applications pending covering various aspects of the PURE EP Platform
- 1 allowed and 1 pending U.S. patent applications directed to artificial intelligence (AI)
- Licenses to 11 patents and 9 additional worldwide utility patent applications pending from Mayo Foundation for Medical Education and Research
BIOSIG AI SCIENCES RECEIVES $2.2 MILLION IN SEED FUNDING TO ADVANCE DEVELOPMENT OF ARTIFICIAL INTELLIGENCE APPLICATIONS
DEAL TO CREATE ADDITIONAL VALUE THROUGH SUBSIDIARY TO ADVANCE ARTIFICIAL INTELLIGENCE STRATEGY WITHOUT DILUTION TO BIOSIG TECHNOLOGIES SHAREHOLDERS
Westport, CT, July 25, 2023 (GLOBE NEWSWIRE) — BioSig Technologies, Inc. (NASDAQ: BSGM) (“BioSig” or the “Company”), a medical technology company delivering unprecedented accuracy and precision to intracardiac signal visualization, today announced the completion of a seed funding round raising $2.2 million for BioSig AI Sciences, Inc. (“BAIS”), a subsidiary of the Company. BAIS intends to join BioSig’s world class technology team with external partners and collaborators to advance the research and development of an artificial intelligence (“AI”) medical device platform.
“The integration of AI and machine learning in electrophysiology devices is powering substantial expected growth for this market, and we intend to be a leader in developing applications of these technologies,” said Ken Londoner, Chairman, CEO and Founder of BioSig. “Our current platform and relationships have created interest and excitement and our development team are making demonstrations for early adopters” added Londoner.
BioSig and Reified Labs’ initial AI collaboration, which began in 2019, has resulted in multiple patent applications to date and a research publication on AI-enhanced electrocardiogram lead placement mapping. The renewed collaboration, BAIS, is also looking into the application of Chat-GPT like large language models and how they apply to helping our hospital partners leverage such technology to solve the myriad of challenges they currently face.
According to Data Bridge Market Research, the market for artificial intelligence in healthcare, estimated at $9.6 billion in 2022, is expected to reach $272.9 billion by 2030, at a CAGR of 51.9% during the forecast period.1
About BAIS
BAIS, a majority-owned Delaware C Corporation subsidiary of BioSig, is developing AI solutions for the hospital marketplace utilizing structured, semi-structured, and unstructured data.
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.
In February of 2023, Ascendiant Capital Markets’ analyst, Edward Woo, tagged BSGM with a $5.00 target.
Here’s some key highlights from the report:
Focused on PURE EP: The company has developed the PURE EP system whose enhanced signal acquisition, digital signal processing, and analysis provides key data used during ablation of cardiac arrhythmias. The PURE EP System is a FDA 510(k) cleared (in August 2018) non-invasive class II device.
Targeting heart disease: In the U.S., heart disease is the leading cause of death for men, women, and people of most racial and ethnic groups, contributing to about 20 – 25% of deaths in the U.S. every year. Every 40 seconds, someone in the U.S. has a heart attack. Arrhythmia is a leading condition and contributing cause for heart disease.
PURE EP system: The PURE (Precise Uninterrupted Real-time evaluation of Electrograms) EP (Electrophysiology) System is designed to provide essential diagnostic signals during all types of cardiac catheter ablations (a procedure that involves delivery of energy through the tip of a catheter to correct heart rhythm arrhythmias). PURE EP is designed to address long-standing limitations that slow and disrupt cardiac catheter ablation procedures, such as environmental lab noise, signal saturation, slow signal recovery, and inaccurate display of fractionated potentials.
PURE EP benefits: PURE EP’s features may allow physicians to better determine precise ablation targets, strategy, and end point of procedures with the objective of reducing the need for patients to undergo multiple procedures, and to allow for less experienced EP physicians to perform more complex procedures. It is estimated that over half of cardiac ablation procedures are not successful (requires additional ablation procedures).
3,000 procedures and growing: To date, more than 3,000 patient procedures have been conducted with the PURE EP System by more than 80 electrophysiologists across 21 different clinical sites in the U.S. The PURE EP System is currently in national commercial launch in the U.S. at healthcare systems such as Mayo Clinic, Texas Cardiac Arrhythmia Institute, Cleveland Clinic, and Kansas City Heart Rhythm Institute.
Market opp’s: According to Health Research International, it is estimated that there are 8,163 global EP lab rooms (with an estimated 3,500 in the U.S.) performing catheter ablations. The rapidly growing EP market is projected to reach $16Bn by 2028 (+11.2% annual growth rate).
However, challenges exist: BioSig operates in a highly competitive environment and competes against a wide range of other technologies. There is the chance that competing technologies may challenge BioSig technologies or that existing standard of care methods remains the industry standard.
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.
NEWS
BIOSIG’S NEW PURE EP™ SUBSCRIPTION MODEL ADOPTED BY MAYO CLINIC-PHOENIX FOR WORLD-CLASS CARDIAC CARE
November 2, 2023
BIOSIG ADDS FIVE NEW PATENT AWARDS TO 100+ TOTAL PATENT PORTFOLIO COVERING DIGITAL SIGNAL PROCESSING TECHNOLOGY AND AI
November 1, 2023
BIOSIG AI SCIENCES ACHIEVES INFRASTRUCTURE AND TECHNOLOGY PROGRESS IN DEVELOPMENT OF GENERATIVE AI PLATFORM FOR HOSPITALS
August 24, 2023
BIOSIG INTRODUCES NEW SUBSCRIPTION MODEL FOR PURE EP™ PLATFORM, OFFERING QUICKER ACCESS TO LATEST FEATURES, CUSTOMIZATIONS
August 23, 2023
BIOSIG’S PURE EP™ PLATFORM DEBUTS NEW AUTOMATED FEATURES IN FIRST PATIENT CASES
August 22, 2023
BIOSIG AI SCIENCES RECEIVES $2.2 MILLION IN SEED FUNDING TO ADVANCE DEVELOPMENT OF ARTIFICIAL INTELLIGENCE APPLICATIONS
July 25, 2023
BIOSIG AI SCIENCES SELECTED FOR NVIDIA INCEPTION PARTNERSHIP PROGRAM TO SUPPORT R&D COLLABORATION ON AI MEDICAL DEVICE PLATFORM FOR HOSPITALS
July 20, 2023
BIOSIG JOINS WEBULL CORPORATE CONNECT
June 29, 2023
BIOSIG ADVANCES COLLABORATION ON MACHINE LEARNING AND ARTIFICIAL INTELLIGENCE SOLUTIONS FOR HEALTHCARE
June 27, 2023
NEW DATA AT HEART RHYTHM 2023 SUGGESTS THAT UNIPOLAR SIGNALS MAY BE USED FOR A MORE PRECISE, ACCURATE APPROACH TO TREATING ARRHYTHMIAS
May 19, 2023
BIOSIG TO HIGHLIGHT NEW DATA FROM THE PURE EP™ PLATFORM AT HEART RHYTHM 2023
May 3, 2023
BIOSIG ANNOUNCES NEW ADVISORY BOARD MEMBER EDWIN WANG
March 27, 2023
BIOSIG ANNOUNCES NEW ADVISORY BOARD MEMBER LORRAINE SPURGE
March 24, 2023
BIOSIG CONFIRMS NO EXPOSURE TO SILICON VALLEY BANK
March 13, 2023
BIOSIG REGAINS COMPLIANCE WITH ALL NASDAQ LISTING STANDARDS
February 22, 2023
BIOSIG AWARDED US PATENT CLAIMS FOR ITS UNIVERSAL NOTCH FILTER TECHNOLOGY
February 17, 2023
BIOSIG APPOINTS FORMER QORVO CFO AS SUCCESSOR TO STEVE CHAUSSY
February 7, 2023
BIOSIG ISSUES SHAREHOLDER UPDATE TO HIGHLIGHT RECENT ACHIEVEMENTS AND ONGOING DEVELOPMENTS
January 19, 2023
BIOSIG EXECUTES AGREEMENT WITH BELLIN HEALTH FOR THE ACQUISITION OF ITS PURE EP™ TECHNOLOGY
January 10, 2023
MANAGEMENT
KENNETH L. LONDONER, MBA
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.
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 BEEN COMPENSATED A FEE OF TWELVE THOUSAND USD BY SICA MEDIA LLC FOR A ONE DAY BSGM AWARENESS CAMPAIGN. 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. 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. 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.