BioStem Technologies, Inc. (OTC: BSEM) has announced the publication of a retrospective study in the International Wound Journal demonstrating the clinical efficacy of its BioREtain-processed placental membranes (RE-AC) in treating diabetic foot ulcers (DFUs). The study compared RE-AC to the standard of care (SOC) in a real-world population with large, hard-to-heal, complex chronic DFUs, revealing a significant advantage in 12-week wound healing rates for the RE-AC-treated group.
Study Details and Results
The retrospective analysis evaluated the effectiveness of RE-AC compared to SOC in healing DFUs. The study included 21 subjects meeting specific inclusion criteria, such as wound type (DFU), medical history, and previous treatment involving the RE-AC placental membrane product. The DFU wounds in the study were considerably larger than those typically included in randomized controlled trials (RCTs), averaging nearly 14 cm², compared to an average wound size of about 5 cm² in most RCTs.
The study demonstrated that patients treated with RE-AC experienced an 8.53% higher probability of achieving full wound closure compared to the SOC group after 12 weeks. For wounds that did not achieve complete closure, the RE-AC group showed a 93.6% improvement in expected area reduction, whereas the SOC group either stalled or grew larger. The relative risk for wound closure in the RE-AC group was 52% higher than in the SOC group.
BioStem Technologies' Perspective
"We are consistently proving the clinical effectiveness of our BioREtain technology through retrospective studies published in peer-reviewed journals," said Jason Matuszewski, CEO of BioStem Technologies Inc. "This study evaluated very challenging DFUs, characterized by long, complicated histories and significantly larger sizes compared to those seen in most controlled studies, and we are thrilled that this study highlighted the unique benefits of BioREtain-processed membranes compared to the standard of care. As we advance our clinical strategy, we will continue conducting head-to-head studies to demonstrate wound healing superiority for our products, resulting in an increase in market awareness and adoption of our products."
Diabetic Foot Ulcers: A Significant Medical Challenge
Diabetic foot ulcers (DFUs) are a serious and chronic condition affecting millions of individuals within the diabetic population. Approximately 15% of people with diabetes will develop foot ulcers, and 6% of these individuals may require hospitalization due to infections or other complications. DFUs are the leading cause of lower extremity amputations in the U.S., with studies indicating that between 14% and 24% of individuals with diabetes who develop foot ulcers will ultimately need an amputation.
Recent data analysis revealed that 2.2 million patients received treatment for DFUs in 2023, with numbers projected to rise in the coming years. The annual treatment costs are estimated between $9 billion and $13 billion in the United States alone.
