BioStem Technologies, Inc. (OTC: BSEM) has commenced a pivotal clinical trial, BR-AM-DFU (BioREtain® Amniotic Membrane - Diabetic Foot Ulcers), to investigate the therapeutic benefits of its BioREtain® technology, utilizing Vendaje®, in the treatment of non-healing diabetic foot ulcers. The study aims to demonstrate the superiority of Vendaje® over the standard of care in promoting wound closure and improving patient outcomes.
The BR-AM-DFU trial is designed as a multicenter, randomized, controlled study, enrolling 60 patients with non-healing DFUs across approximately twelve sites in the United States. The patient population will consist of individuals with diabetic foot ulcers exhibiting adequate perfusion and no clinical signs or symptoms of infection. Weekly visits will be conducted to monitor adherence to wound care protocols, off-loading, and to document wound closure progress.
Trial Design and Objectives
The primary objective of the BR-AM-DFU trial is to determine whether the addition of Vendaje® to standard care enhances the likelihood of achieving complete wound closure in DFUs compared to standard care alone. Complete wound closure is defined as 100% re-epithelialization within a 12-week treatment period. A follow-up phase will assess the longevity and durability of the closed wound over a four-week period with two visits at each two-week interval.
Jason Matuszewski, CEO of BioStem Technologies, stated, "We are committed to advancing clinical trials that benchmark our products against the standard of care. While Vendaje is already commercially available, demonstrating clinical effectiveness is crucial to driving increased market adoption. Vendaje is an innovative wound care option for patients with chronic, non-healing wounds, and this trial represents a key milestone in showcasing our BioREtain technology within the diabetic foot ulcer market."
Market Context and Clinical Need
Diabetic foot ulcers represent a significant clinical challenge, affecting approximately 15% of people with diabetes, according to the American Podiatric Medical Association (APMA). A concerning 6% of these individuals may require hospitalization due to infections or other ulcer-related complications. DFUs are the primary cause of lower extremity amputations in the U.S., with studies indicating that 14% to 24% of individuals with diabetes who develop foot ulcers will ultimately require amputation.
Recent data analysis indicates that 2.2 million patients received treatment for DFUs in 2023, with these numbers expected to rise. The annual treatment costs for DFUs in the United States alone are estimated to range between $9 billion and $13 billion, underscoring the substantial economic burden of this condition.
BioREtain® Technology
BioStem's placental allografts are processed using the company's proprietary BioREtain® method, which preserves the tissue's endogenous biological 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, preserving the natural integrity of the amniotic tissue components critical to the wound treatment process.
Ongoing Clinical Trials
This BR-AM-DFU trial marks BioStem's second active clinical trial focused on diabetic foot ulcers. The first trial, BR-AC-DFU-101 (BioREtain® – Amnion Chorion – Diabetic Foot Ulcers), initiated in October 2024, is evaluating the effectiveness of the company’s AmnioWrap2™ placental tissue in treating patients with DFUs.
