BioStem Technologies Completes Enrollment in Clinical Trial Evaluating BioREtain® Amnion Chorion for Treatment of Diabetic Foot Ulcers

Head-to-head study comparing BioREtain^®- processed Amnion Chorion (BR-AC) allograft to standard of care initiated in Q4 2024 to demonstrate healing superiority



Topline results and full data analysis expected in Q4 2025

POMPANO BEACH, Fla., June 23, 2025 (GLOBE NEWSWIRE) -- BioStem Technologies, Inc. (“BioStem” or the “Company”) (OTC: BSEM), a leading MedTech company focused on the development, manufacturing, and commercialization of placental-derived products for advanced wound care, today announced that patient enrollment has been completed in the Company’s clinical trial evaluating BioREtain® Amnion Chorion (BR-AC) versus standard of care for patients with non-healing diabetic foot ulcers (DFUs).

The BR-AC-DFU-101 study is a multicenter, randomized, controlled trial that was initiated in Q4 2024 at 11 sites across the U.S. to evaluate at least 60 patients with non-healing DFUs. The primary objective is to determine whether DFUs treated with standard care plus BR-AC achieve a higher probability of complete wound closure over a 12-week period when compared to standard care alone. BioStem recently completed enrollment of 71 patients in the study, with topline data expected to be reported during the fourth quarter of 2025.

“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 the Board of BioStem Technologies. “I’m pleased that this trial has completed patient enrollment and remains on schedule to report results later this year. 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.”

Trial Primary & Secondary Outcome Objectives:

The primary outcome of the study is to determine whether DFUs treated with standard care plus BR-AC results in a higher probability of achieving complete wound closure compared to standard care alone over a 12-week period.

Secondary outcome measures include:

• Comparing treatment group differences in proportions of wounds achieving complete wound closure based on time in days.
• Comparing treatment group differences in wound area and volume.
• Assessing total number of applications of BR-AC required to achieve complete wound closure.
  
  

Clinical Trial Information:

For more information about the BR-AC-DFU-101 study, please visit Clinical Trials.gov for a full overview:

• Title: A Prospective Trial of Non-healing Diabetic Foot Ulcers Treated with Standard Care with or Without BR-AC
• Link: 

Diabetic Foot Ulcer 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 allografts are processed utilizing the Company’s proprietary BioREtain^® method, which retains the tissue’s native 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 wound treatment. For a full overview of BioREtain^®, please visit: .

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About BioStem Technologies, Inc. (OTC: BSEM):

BioStem Technologies is a leading innovator focused on harnessing the natural properties of perinatal tissue in the development, manufacture, and commercialization of allografts for advanced wound care. The Company is focused on manufacturing products that change lives, leveraging its proprietary BioREtain^® processing method. BioREtain^® has been developed by applying the latest research in advanced wound care, focused on maintaining growth factors and preserving tissue structure.

BioStem’s quality management systems and standard operating procedures are accredited by the American Association of Tissue Banks (“AATB”) and adhere to Good Tissue Practices (cGTP and Good Manufacturing Processes (“cGMP”). Our portfolio of quality brands includes AmnioWrap2™, VENDAJE^®, VENDAJE AC^®, VENDAJE OPTIC^®, American Amnion and American Amnion AC. Each BioStem Technologies placental allograft is processed at the Company’s FDA registered and AATB accredited site in Pompano Beach, Florida.

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Contact BioStem Technologies, Inc.:

Phone: 954-380-8342

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Investor Relations:

Adam Holdsworth

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Phone: 917-497-9287

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