BioStem Technologies has completed patient enrollment in its pivotal clinical trial evaluating a placental-derived allograft for treating diabetic foot ulcers, marking a significant milestone in the company's efforts to address a condition that affects millions of Americans and costs the healthcare system billions annually.
The BR-AC-DFU-101 study enrolled 71 patients across 11 U.S. sites, exceeding the initial target of 60 participants. The multicenter, randomized, controlled trial compares BioREtain Amnion Chorion (BR-AC) allograft plus standard care against standard care alone in patients with non-healing diabetic foot ulcers.
Trial Design and Objectives
The study's primary objective is to determine whether diabetic foot ulcers treated with standard care plus BR-AC achieve a higher probability of complete wound closure over a 12-week period compared to standard care alone. Secondary endpoints include comparing treatment group differences in wound closure timing, wound area and volume changes, and the total number of BR-AC applications required for complete healing.
"We are currently advancing three clinical trials to demonstrate the efficacy and competitive advantage of BioREtain-processed allografts," said Jason Matuszewski, CEO and Chairman of BioStem Technologies. "I'm pleased that this trial has completed patient enrollment and remains on schedule to report results later this year."
The trial was initiated in Q4 2024, with topline data expected during the fourth quarter of 2025. BioStem is simultaneously conducting two additional studies targeting venous leg ulcers using BR-AC and diabetic foot ulcers using BR-A, both remaining on schedule according to the company.
Addressing a Critical Medical Need
Diabetic foot ulcers represent a serious medical challenge with substantial clinical and economic implications. According to the American Podiatric Medical Association, approximately 15% of people with diabetes will develop foot ulcers, with 6% requiring hospitalization due to infections or complications.
The condition carries severe consequences, as diabetic foot ulcers are the leading cause of lower extremity amputations in the United States. Studies indicate that between 14% and 24% of individuals with diabetes who develop foot ulcers will ultimately require amputation.
Recent data from GlobalData Plc. revealed that 2.2 million patients received treatment for diabetic foot ulcers in 2023, with numbers projected to rise. The economic burden is substantial, with annual treatment costs estimated between $9 billion and $13 billion in the United States alone.
BioREtain Technology Platform
BioStem's allografts are processed using the company's proprietary BioREtain method, which retains tissue's native properties while maintaining the structure and matrix found in fresh perinatal tissue. The patented six-step BioREtain process is designed to be gentle and minimally invasive while preserving the natural integrity of amniotic tissue components critical to wound treatment.
The company's quality management systems and standard operating procedures are accredited by the American Association of Tissue Banks and adhere to Good Tissue Practices and Good Manufacturing Processes. BioStem's portfolio includes AmnioWrap2, VENDAJE, VENDAJE AC, VENDAJE OPTIC, American Amnion, and American Amnion AC, all processed at the company's FDA-registered and AATB-accredited facility in Pompano Beach, Florida.
Clinical Development Strategy
Matuszewski emphasized the company's commitment to building robust clinical evidence: "We continue to enroll patients in two additional studies targeting venous leg ulcers using BR-AC and diabetic foot ulcers using BR-A. Both trials remain on schedule and reflect our commitment to building a strong body of clinical evidence. We believe the results of these studies will further validate the BioREtain allograft platform and support expanded physician adoption and commercial expansion."
The completion of enrollment in the BR-AC-DFU-101 study represents a key milestone for BioStem as it seeks to establish clinical evidence for its placental-derived products in the competitive advanced wound care market.
