POMPANO BEACH, Fla. — January 7, 2026 — Leads & Copy — BioStem Technologies, Inc. (OTC: BSEM) commented today on the withdrawal of all seven of the Centers for Medicare & Medicaid Services’ (“CMS”) Local Coverage Determinations (“LCD”) for skin substitute grafts/cellular and tissue-based products for the treatment of diabetic foot ulcers (“DFU”) and venous leg ulcers (“VLU”) that would have been effective on January 1, 2026.
The decision ensures continued patient access to VENDAJE® and VENDAJE AC®.
Jason Matuszewski, CEO and Chairman of the Board of BioStem said that the company appreciates the thoughtful collaboration during this period between clinical partners, policymakers, and advocacy organizations as they continue to shape an evolving reimbursement environment that optimizes patient care while supporting innovation and fiscal responsibility.
Matuszewski also noted that the recent withdrawal of the LCDs is not expected to impact patient access to BioStem’s technology or their ability to serve patients and clinicians.
The company believes that long-term adoption and value creation will be driven by high-quality clinical evidence and remain firmly committed to an evidence-based strategy, even with broader coverage criteria. BioStem will continue to invest in expanding its foundation of clinical data to demonstrate the differentiated performance of their proprietary technology relative to alternative options.
BioStem Technologies is 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 in compliance with current Good Tissue Practices (“cGTP”) and current Good Manufacturing Processes (“cGMP”).
The company’s portfolio of quality brands includes AmnioWrap2™, VENDAJE®, VENDAJE AC®, VENDAJE OPTIC®, American Amnion™, and American Amnion AC™. Each BioStem Technologies placental allograft is processed at the Company’s FDA registered and AATB accredited site in Pompano Beach, Florida.
Contact Philip Trip Taylor, Gilmartin Group, at ir@biostemtech.com for investor relations.
Source: BioStem Technologies, Inc.
