Core Insights - BioStem Technologies, Inc. announced that its BioRetain® allografts significantly improve the probability of achieving lasting wound closure in patients with non-healing diabetic foot ulcers (DFUs) compared to standard care [1][2]. Clinical Trial Results - The BR-AC-DFU-101 study was a multicenter, randomized, controlled trial involving 71 patients with Wagner 1 or 2 DFUs, demonstrating that the BR-AC arm was nearly twice as likely to achieve lasting wound closure compared to standard care alone [2][3]. - The probability of healing in the BR-AC arm was 53%, while the standard care arm had a 31% probability, indicating a significant treatment benefit [5]. Patient Population and Study Design - The trial included a rigorous patient selection process, ensuring only those with hard-to-heal wounds were enrolled, reflecting a population requiring treatment beyond standard care [2][3]. - A 2-week run-in period was implemented to assess patient response to standard care, with only those not showing a greater than 30% reduction in wound size allowed to participate [3]. Industry Context - Diabetic foot ulcers affect approximately 15% of individuals with diabetes, with 6% requiring hospitalization due to complications [7]. - The economic burden of DFUs in the U.S. is estimated between $9 billion and $13 billion annually, with treatment numbers projected to rise due to an aging population [8]. Company Overview - BioStem Technologies focuses on developing placental-derived products for advanced wound care, utilizing its proprietary BioRetain processing method to maintain the natural integrity of amniotic tissue [9][11]. - The company is also conducting studies targeting venous leg ulcers using BR-AC, aiming to further validate its allograft platform and enhance physician adoption [4].