BioStem Technologies Reports Positive Top-Line Clinical Results Demonstrating Superior Outcomes with BioRetain® Allograft in Diabetic Foot Ulcers

Core Insights - BioStem Technologies, Inc. announced positive top-line results from its clinical trial evaluating BioRetain® - Processed Amnion Chorion (BR-AC) for treating non-healing diabetic foot ulcers (DFUs) [1][2] - The trial demonstrated that patients treated with BR-AC were almost twice as likely to achieve lasting wound closure compared to those receiving standard care alone [2][6] Clinical Trial Details - The BR-AC-DFU-101 study was a multicenter, randomized, controlled trial initiated in Q4 2024, involving 71 patients with Wagner 1 or 2 DFUs across 11 U.S. sites [2][3] - The primary objective was to assess the probability of complete wound closure over a 12-week period for patients treated with standard care plus BR-AC versus standard care alone [2][5] Patient Selection and Methodology - A rigorous patient selection process ensured only those with hard-to-heal wounds were enrolled, following FDA guidelines for cutaneous ulcers [2][3] - A 2-week run-in period was implemented to evaluate patient response to standard care, excluding those with significant initial improvement [3] Results and Efficacy - The probability of healing in the BR-AC group was 53%, compared to 31% in the standard care group, indicating superior clinical outcomes for BR-AC [6] - Future publications will address secondary outcome measures related to treatment efficacy and application frequency [5][7] Industry Context - Diabetic foot ulcers affect approximately 15% of individuals with diabetes, with significant hospitalization risks and complications [8] - In 2023, an estimated 2.2 million patients received treatment for DFUs, with treatment costs in the U.S. ranging from $9 billion to $13 billion annually [9] Company Overview - BioStem Technologies focuses on developing placental-derived products for advanced wound care, utilizing its proprietary BioRetain processing method to maintain tissue integrity [12][10] - The company is committed to expanding its clinical research and product offerings, including ongoing studies targeting venous leg ulcers [4]