BioStem Technologies Launches Clinical Trial to Demonstrate the Therapeutic Benefits of its BioREtain® Technology in Treating Diabetic Foot Ulcers Using Vendaje®
Study of Vendaje® versus standard of care aims to show superior wound treatment, supporting market expansion
POMPANO BEACH, Fla., Jan. 08, 2025 (GLOBE NEWSWIRE) —
BioStem Technologies, Inc.
(OTC: BSEM), a leading MedTech company focused on the development, manufacturing, and commercialization of placental-derived products for advanced wound care, announces the initiation of the BR-AM-DFU (BioREtain
®
Amniotic Membrane – Diabetic Foot Ulcers) clinical trial to evaluate
Vendaje
®
versus standard of care for patients suffering with non-healing diabetic foot ulcers.
Jason Matuszewski, CEO of BioStem Technologies, commented
: “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. As we continue to onboard patients for the trial, we look forward to sharing updates on key clinical milestones.”
BR-AM-DFU Clinical Trial Overview and Design:
Title:
Non-healing Diabetic Foot Ulcers Treated with Standard Care, With or Without BR-AM
Primary Outcome Measures:
The primary objective of this study is to assess whether the addition of Vendaje to standard care increases the likelihood of achieving complete wound closure in diabetic foot ulcers (DFUs) compared to standard care alone. The study will evaluate the proportion of subjects who achieve full wound closure, defined as 100% reepithelialization, over a 12-week treatment period.
ClinicalTrials.gov Link:
HERE
The BR-AM-DFU trial is a multicenter, randomized, controlled study that will enroll 60 patients with non-healing DFUs at approximately twelve sites across the United States. The study will focus on a patient population with diabetic foot ulcers (DFUs) that have adequate perfusion and no clinical signs or symptoms of infection. Weekly visits will be conducted to monitor compliance with wound care protocols and off-loading, as well as to document when wound closure is achieved. A follow-up phase will commence for all subjects that achieve complete wound closure, which is designed to measure longevity and durability of the closed wound. This follow-up will consist of a four-week period with two visits at each two-week interval.
Supporting Ongoing Clinical Trials:
This is the second clinical trial launched by BioStem that is actively enrolling patients. The first trial, BR-AC-DFU-101 (BioREtain
®
– Amnion Chorion – Diabetic Foot Ulcers),
was initiated in October 2024
and is evaluating the effectiveness of the company’s AmnioWrap2™ placental tissue in treating patients with DFUs. To learn more about that trial, please visit the trial overview on
ClinicalTrials.gov
.
Diabetic Foot Ulcers Market Statistics:
Diabetic foot ulcers (DFUs) are a serious and chronic condition affecting millions of individuals within the diabetic population. According to the American Podiatric Medical Association (APMA), a leading authority on foot and ankle health, approximately 15% of people with diabetes will develop foot ulcers. Alarmingly, 6% of these individuals may require hospitalization due to infections or other complications related to their ulcers. The risks for diabetic patients are substantial, as DFUs are the leading cause of lower extremity amputations in the U.S. Studies indicate that between 14% and 24% of individuals with diabetes who develop foot ulcers will ultimately need an amputation.
Recent data analysis from GlobalData Plc., a prominent global data provider, revealed that 2.2 million patients received treatment for DFUs in 2023, with numbers projected to rise in the coming years. The economic burden of these ulcers on healthcare systems is significant, with annual treatment costs estimated between $9 billion and $13 billion in the United States alone.
About BioREtain
®
:
BioStem’s placental allografts are processed utilizing 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 gentle, minimally invasive, and preserves the natural integrity of the amniotic tissue/components critical to the wound treatment process. For a full overview of BioREtain, please visit:
https://biostemtechnologies.com/our-science/#six-steps
.
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