OUR NEW PROFILE IS: (NASDAQ: MYNZ)
__________
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.
https://platform.twitter.com/embed/Tweet.html?dnt=false&embedId=twitter-widget-0&features=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%3D&frame=false&hideCard=false&hideThread=false&id=1635984953220497409&lang=en&origin=https%3A%2F%2Finsiderfinancial.com%2Fmz1-2%2F&sessionId=5c93c333de74761e6109162229cdf14a37b1dda8&theme=light&widgetsVersion=aaf4084522e3a%3A1674595607486&width=550px
CHECK OUT THE MYNZ INVESTOR PRESENTATION HERE
___________________
Hello Everyone,
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
Visit www.coloalert.com
- A PCR-based CRC early detection stool test
- Up to 60% fewer missed cases compared to fecal immunochemical test (FIT) 10
- Non-invasive, no preparation or sedation, no time off work
- 98% patient satisfaction – Easy product to use 11
- Designed to offer affordable CRC screening solutions
9 Currently not approved for use in the USA
10 Comparing ColoAlert sensitivity with FITs (Gies et al. Gastroenterology 154/2018)
11 98% overall satisfaction with ColoAlert in our internal customer survey.
A STRONG PARTNERSHIP FOR SUSTAINABLE GROWTH
DNA extraction for our flagship product ColoAlert is now automated on the Thermo Scientific™ KingFisher™ Apex.
This essential partnership enables laboratories around the world to increase their testing capacity and to optimize their resource allocation.
- Automated DNA extraction with magnetic particles
- Tailored protocol for ColoAlert
- Up to 96 samples per run in ~ 2 hours*
- Brings convenience, performance and reproducibility to the ColoAlert workflow
* Extraction time, does not include sample pre-treatment. For Laboratory Use. © 2022 Thermo Fisher Scientific Inc. All rights reserved. All trademarks are the property of Thermo Fisher Scientific and its subsidiaries unless otherwise specified.
PROPRIETARY STATE-OF-THE-ART TECHNOLOGY
- 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.”
MAINZ BIOMED PROVIDES YEAR-END 2022 CORPORATE REVIEW
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 COLOALERT PRODUCT, 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.
NEWS
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•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
MANAGEMENT TEAM
GUIDO
BAECHLER
CEO & DIRECTOR
READ MORE
WILLIAM
CARAGOL
CFO
READ MORE
KAREN L.
RICHARDS
VICE PRESIDENT, REGULATORY
READ MORE
MORITZ
EIDENS PHD
CSO & DIRECTOR
READ MORE
AMY
LEVIN
VP REGULATORY
READ MORE
PHILIPP
FREESE
COO
READ MORE
DARIN
LEIGH
CHIEF COMMERCIAL OFFICER
READ MORE
JANE
EDWARDS
VP OF CLINICAL AFFAIRS
READ MORE
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 TWENTY FIVE THOUSAND USD BY A THIRD PARTY, AWARENESS CONSULTING NETWORK LLC FOR A ONE DAY MYNZ 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.