BioStem Technologies Completes Enrollment in Clinical Trial Evaluating BioREtain® Amnion Chorion for Treatment of Diabetic Foot Ulcers

Core Insights - BioStem Technologies, Inc. has completed patient enrollment for a clinical trial comparing BioREtain® Amnion Chorion (BR-AC) to standard care for non-healing diabetic foot ulcers (DFUs) [2][3] - The BR-AC-DFU-101 study aims to evaluate the effectiveness of BR-AC in achieving complete wound closure over a 12-week period [3][5] - Topline results from the study are expected in Q4 2025, with the trial initiated in Q4 2024 across 11 sites in the U.S. [3][4] Company Overview - BioStem Technologies focuses on developing, manufacturing, and commercializing placental-derived products for advanced wound care [2][10] - The company utilizes a proprietary BioREtain processing method that preserves the natural properties of perinatal tissue [8][10] - BioStem's quality management systems are accredited by the American Association of Tissue Banks and adhere to Good Tissue Practices and Good Manufacturing Processes [11] Clinical Trial Details - The primary objective of the BR-AC-DFU-101 study is to determine if the combination of standard care and BR-AC leads to a higher probability of complete wound closure compared to standard care alone [5] - Secondary outcome measures include comparing treatment group differences in wound closure rates, wound area, and volume [7] - The study has enrolled 71 patients, exceeding the initial target of 60 [3][4] Market Context - Diabetic foot ulcers affect approximately 15% of individuals with diabetes, with 6% requiring hospitalization due to complications [5] - The economic burden of DFUs in the U.S. is significant, with annual treatment costs estimated between $9 billion and $13 billion [6] - In 2023, 2.2 million patients received treatment for DFUs, with numbers projected to rise [6]