New York, August 21, 2024 - PRISM MarketView - The MedTech wound care leader BioStem Technologies (BSEM) announced that the Institutional Review Board (IRB) has approved a clinical study to evaluate Vendaje® for diabetic foot ulcers (DFU). Study supports BioStem’s strategic growth initiatives and accelerates product adoption by providing data to healthcare professionals and payers on the benefits of Vendaje. Approximately 14 to 24 percent of people with diabetes that develop foot ulcers will require an amputation. These ulcers pose a significant economic strain on healthcare systems, with annual treatment costs estimated to range from $9 to $13 billion in the United States alone.
The Vendaje product is significant in the company’s placental-derived allograft portfolio. This allograft is minimally manipulated dehydrated tissue that serves as a protective covering for soft tissue wounds. The product is used in private office and hospital/surgical settings, and which is currently reimbursed through Medicare.
The trial is a multi-center randomized, controlled study of non-healing DFUs treated with standard of care with or without Vendaje. The primary endpoint of the study is the percentage of subjects whose target ulcer achieve complete wound closure within 12 weeks.
“This study supports BioStem’s strategic growth initiatives and aims to accelerate product adoption by providing real-world data to healthcare professionals and payers like Medicare on the benefits and value of Vendaje. Our primary goal with these studies is to secure broader payer coverage and increase patient access to Vendaje. With our proprietary BioREtain technology, we deliver a superior product for treating diabetic foot ulcers. We look forward to advancing these trials and will provide regular updates as patient enrollment and treatment progress.”
Jason Matuszewski, CEO of BioStem Technologies
About BioStem Technologies, Inc. (OTC: BSEM): BioStem Technologies is a leading innovator focused on harnessing the natural properties of perinatal tissue in the development, manufacture, and commercialization of allografts for regenerative therapies. The Company is focused on manufacturing products that change lives, leveraging its proprietary BioREtain® processing method. BioREtain® has been developed by applying the latest research in regenerative medicine, focused on maintaining growth factors and preserving tissue structure. BioStem Technologies’ quality management system and standard operating procedures have been reviewed and accredited by the American Association of Tissue Banks (“AATB”). These systems and procedures are established per current Good Tissue Practices (“cGTP”) and current Good Manufacturing Processes (“cGMP”). Our portfolio of quality brands includes AmnioWrap2™, VENDAJE®, VENDAJE AC®, and VENDAJE OPTIC®. Each BioStem Technologies placental allograft is processed at the Company’s FDA registered and AATB accredited site in Pompano Beach, Florida. For more information visit biostemtechnologies.com and follow us on Twitter and Linkedin.
About PRISM MarketView:
Established in 2020, PRISM MarketView is dedicated to the monitoring and analysis of small cap stocks in burgeoning sectors. We deliver up-to-the-minute financial market news, provide comprehensive investor tools and foster a dynamic investor community. Central to our offerings are proprietary indexes that observe emerging sectors, including biotech, clean energy, next-generation tech, medical devices and beyond. Visit us at prismmarketview.com and follow us on X.
Disclaimer:
PRISM MarketView is not a registered or licensed broker-dealer or investment adviser and does not offer investment advice. The information provided in this communication is not intended to constitute an offer to sell, a solicitation of an offer to buy, or a recommendation for any security.
Contact:
Prism MarketView | Stock Market News & Investment Opportunities