BioStem Technologies Comments on Withdrawal of CMS CY 2026 Final Medicare Reimbursement Rule for Skin Substitutes

Core Viewpoint - BioStem Technologies, Inc. has commented on the withdrawal of all seven Local Coverage Determinations (LCDs) by the Centers for Medicare & Medicaid Services (CMS) for skin substitute grafts and cellular products for treating diabetic foot ulcers and venous leg ulcers, effective January 1, 2026, indicating that this will not impact patient access to their technology [1][2]. Company Overview - BioStem Technologies is a MedTech company focused on developing, manufacturing, and commercializing placental-derived products for advanced wound care [1]. - The company utilizes its proprietary BioRetain processing method, which is designed to maintain growth factors and preserve tissue structure [2]. - BioStem's quality management system has been accredited by the American Association of Tissue Banks (AATB) and complies with current Good Tissue Practices (cGTP) and Good Manufacturing Processes (cGMP) [2]. Market and Innovation - The company emphasizes the importance of high-quality clinical evidence for long-term adoption and value creation, committing to an evidence-based strategy [2]. - BioStem plans to continue investing in expanding its clinical data foundation to demonstrate the differentiated performance of its proprietary technology compared to alternatives [2]. Product Portfolio - BioStem's product portfolio includes brands such as AmnioWrap2™, VENDAJE, and American Amnion™, all processed at their FDA registered and AATB accredited site in Pompano Beach, Florida [2].