JUPITER, FL, May 03, 2023 (GLOBE NEWSWIRE) — via NewMediaWire – Marizyme, Inc. (“Marizyme” or the “Company”) (OTCQB: MRZM), today provided the following business update to the stockholders and the investing public from the Company’s Chief Executive Officer, David Barthel.
I am pleased to bring you an update on the Company’s recent developments as well as Marizyme’s current business priorities and goals.
It has been some time since we have had the opportunity to share an update with you, and I am pleased to have the chance to do so now. The Company has continued to move forward with multiple initiatives and the team has been hard at work building a strong foundation for future success.
Over the past year, we made progress in our R&D and commercialization efforts and have several developments in the pipeline that we believe will drive growth in the future. We also raised capital and reduced expenses where possible. We believe that our focus on business priorities is beginning to show results.
In April, Marizyme passed its annual surveillance audit required to maintain its ISO certification and European Union (“EU”) CE marking for DuraGraft®, and is now actively preparing for EU Medical Devices Regulation (MDR) certification. The Company’s primary business priority continues to be working with the FDA where DuraGraft® is currently under review for authorization in the United States.
Additionally, the Company has substantially expanded its intellectual property (“IP”) position for DuraGraft® in the United States and around the globe and has recently been awarded, granted, and/or allowed patents for Krillase® and MATLOC™ related technologies.
Key Accomplishments and Updates
Our flagship product, DuraGraft®, is not yet available in the United States but is currently under review for authorization by the FDA. DuraGraft® is commercially available in the EU and certain other markets.
- Generated revenue with our distribution partners from sales in Spain, Philippines, Germany, -Switzerland, Singapore, Malaysia, Turkey, Ireland, and Austria.
- Engaged Kimal PLC as exclusive distribution partner in the United Kingdom.
- Engaged Medical Instruments S.p.A as exclusive distribution partner in Italy.
- Completed regulatory and manufacturing transition to produce “Marizyme” labeled DuraGraft® products for sale in the EU and certain other markets.
- Contributed to recent publications on DuraGraft®-related clinical data in high impact peer-reviewed medical journals:
- Troponin/Szalkiewicz et al. Graft Preservation Confers Myocardial Protection during Coronary Artery Bypass Graftin. Published in Frontiers of Cardiovascular Medicine(1),
- Left Main/Caliskan et al. Clinical Event Rate in Patients with and Without Left Main Disease undergoing Isolated Coronary Artery Bypass Grafting: Results from the European DuraGraft Registry. Published in European Journal of Cardiothoracic Surgery(2),
- Whole Cohort/Sandner et al. Clinical Outcomes and Quality of Life After Contemporary Isolated Coronary Bypass Grafting: A Prospective Cohort Study. Published in The International Journal of Surgery(3)
- MAR-FG-001 – Based on Marizyme’s CytoProTM technology, this product is under development for use in fat-grafting procedures during plastic and reconstructive surgical procedures.
- MATLOC™ – An integrated point-of-care screening and diagnosis device for chronic kidney disease under development under a Sponsored Research Agreement.
2023 Business Priorities
- Seeking Authorization by the FDA for use of DuraGraft® in the United States for CABG surgery procedures.
- Preparing the U.S. market for DuraGraft® with key opinion leaders and a strategic partner.
- Generating recurring revenue with global distribution partners.
- Expanding distribution network with a focus on Europe and Asia.
- Advancing MAR-FG-001 into clinical development.
- Establishing strengthened capital resources and maintaining corporate governance.
- Developing further our intellectual property portfolio.
- Supporting publications and clinical data on DuraGraft® to support commercialization.
Stock Exchange Listing Update
On February 14, 2022, the Company initially filed a registration statement on Form S-1 with the U.S. Securities and Exchange Commission (the “SEC”) for registration of an underwritten public offering and simultaneous listing of its securities on the Nasdaq Capital Market tier of The Nasdaq Stock Market LLC (“Nasdaq”). On April 21, 2023, the Company filed a formal request with the SEC for its consent to the withdrawal of its registration statement because it does not intend to pursue the contemplated public offering at this time.
The Company is continuously evaluating market conditions with its advisors, and in the future may proceed with its listing application with Nasdaq or seek approval for listing of its securities on another national securities exchange in connection with a direct listing, a public offering, or other listing process.
We expect to provide further updates on our business developments and plans in the months to come.
I want to thank everyone involved in Marizyme for their support and commitment to the Company.
Dave Barthel, Chief Executive Officer
(1) Frontiers in Cardiovascular Medicine. (2022, July 28). Graft Preservation Confers Myocardial Protection during Coronary Artery Bypass Grafting. Frontiers. https://www.frontiersin.org/articles/10.3389/fcvm.2022.922357/full
(2) European Journal of Cardiothoracic Surgery. (2022, August 5). Clinical Event Rate in Patients with and Without Left Main Disease undergoing Isolated Coronary Artery Bypass Grafting: Results from the European DuraGraft Registry. Oxford Academic. https://academic.oup.com/ejcts/article-abstract/62/4/ezac403/6656349
(3) International Journal of Surgery. (2023, March 14.) Clinical Outcomes and Quality of Life After Contemporary Isolated Coronary Bypass Grafting: A Prospective Cohort Study. Published in The International Journal of Surgery. Journals. https://journals.lww.com/international-journal-of-surgery/Abstract/9900/Clinical_outcomes_and_quality_of_life_after.131.aspx
Marizyme is a multi-technology biomedical company dedicated to the accelerated development and commercialization of medical technologies that improve patient health outcomes. Marizyme is focused on the development and commercialization of medical technologies, devices and related products. Currently, we are focused on developing three medical technologies and products – DuraGraft®, MATLOC™ and Krillase® – each of which is backed by a portfolio of patented or patent-pending assets.
DuraGraft® is approved for use in the EU as well as certain other markets. DuraGraft® has not been approved for use in the U.S. MAR-FG-001, MATLOC™ and Krillase® are not approved for sales in any market. For more information about Marizyme, please visit www.marizyme.com.
Forward Looking Statements
This press release contains statements that do not relate to historical facts but are “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements can generally (although not always) be identified by their use of terms and phrases such as anticipate, appear, believe, continue, could, estimate, expect, indicate, intend, may, plan, possible, predict, project, pursue, will, would and other similar terms and phrases, as well as the use of the future tense. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on current beliefs, expectations and assumptions regarding the future of the business of the Company, future plans and strategies, projections, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of the Company’s control, including the risks described in the Company annual reports on Form 10-K under the heading “Risk Factors” as filed with the SEC. Actual results and financial condition may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Forward-looking statements in this press release speak only as of the date hereof. Unless otherwise required by law, the Company undertakes no obligation to publicly update or revise these forward-looking statements, whether as a result of new information, future events or otherwise.
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