BioStem Technologies Reports Positive Top-Line Clinical Results Demonstrating Superior Outcomes with BioRetain® Allograft in Diabetic Foot Ulcers

Rhea-AI Summary

BioStem Technologies (OTC: BSEM) reported top-line randomized controlled trial results published in the International Journal of Tissue Repair showing BioRetain (BR-AC) produced higher lasting wound-closure rates than standard of care in hard-to-heal diabetic foot ulcers (DFUs).

Key metrics: probability of lasting closure 53% for BR-AC vs 31% for standard of care over a 12-week period; study enrolled 71 patients across 11 U.S. sites, initiated Q4 2024, with lasting closure defined as remaining closed for 4 weeks. Future publications will report secondary endpoints including time to closure, wound area/volume change, and number of BR-AC applications.

Positive

• Probability of lasting closure BR-AC 53% vs SOC 31%
• Enrollment completed: 71 patients across 11 U.S. sites
• Peer-reviewed publication results published in International Journal of Tissue Repair

Negative

• Only top-line primary results released; secondary endpoints pending
• 12-week primary window may limit assessment of longer-term durability

Randomized controlled trial results published in the International Journal of Tissue Repair demonstrate BioRetain® allografts significantly improve probability of achieving lasting wound closure versus standard of care

POMPANO BEACH, Fla., Oct. 31, 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 top-line results of the Company’s clinical trial evaluating BioRetain® - Processed Amnion Chorion (BR-AC) versus standard of care for patients with non-healing diabetic foot ulcers (DFUs), as published in the International Journal of Tissue Repair.

Top-Line Results

• BR-AC achieved superior clinical outcomes in this patient population.
• The probability of healing in the BR-AC arm was 53% while the probability of healing in the standard of care arm was 31%, utilizing complete closure instead of initial incidence of closure as the endpoint.

“This trial was conducted with a degree of rigor not typically seen in the published literature,” explained Dr. Bert Slade, Chairman of BioStem’s Medical Advisory Board. “The patient selection criteria ensured that only those patients with the hardest-to-heal wounds were enrolled, and the definition of closure followed the 2006 FDA guidance for cutaneous ulcers, the most rigorous standards established. Importantly, utilizing complete closure instead of initial incidence of closure, the BR-AC arm was almost twice as likely to achieve lasting wound closure than patients treated with standard of care alone, providing strong evidence of treatment benefit.”

BR-AC allografts are used as a protective covering to optimize the wound treatment environment. 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 was to determine whether DFUs treated with standard of care plus BR-AC achieved a higher probability of complete wound closure over a 12-week period when compared to standard of care alone. BioStem completed enrollment of 71 patients with Wagner 1 or 2 DFUs.

The BR-AC-DFU trial included a 2-week run-in period to evaluate how a patient responded to standard of care alone. Significantly, any patient that experienced a greater than 30% reduction in wound size after this time was not permitted to randomize into the study. This ensured that only patients with “hard-to-heal wounds” were enrolled in the trial, reflecting a patient population with a DFU requiring treatment beyond the standard of care. Following initial closure, wounds were required to remain closed for 4 weeks to qualify as achieving lasting closure.

“We are very pleased that this study has demonstrated the effectiveness of BioRetain-processed placental allografts in achieving wound closure in patients with hard-to-heal wounds,” said Jason Matuszewski, CEO and Chairman of the Board of BioStem Technologies. “Previously reported comparisons of BioRetain versus competitive technologies have demonstrated its superiority in retaining the natural structural and molecular composition of the native tissue. This study reinforces the clinical performance of our technology. We continue to enroll patients in a study targeting venous leg ulcers using BR-AC and look forward to reporting those results. We believe the results of these studies will further substantiate the BioRetain allograft platform and drive expanded physician adoption and commercial traction.”

Future Publications:
The primary outcome of the study published in this report was to determine whether DFUs treated with standard care plus BR-AC resulted in a higher probability of achieving complete wound closure compared to standard care alone over a 12-week period.

Future publications will address secondary outcome measures, including, but not limited to:

• 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.
  

Diabetic Foot Ulcers:
Diabetic foot ulcers 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 Global Data 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. This growth is closely linked to the aging population, as advancing age is associated with a higher prevalence of diabetes, peripheral vascular disease, and impaired wound healing; all key risk factors for DFUs. The economic burden of these ulcers on healthcare systems is significant, with annual treatment costs estimated between $9 billion and $13 billion in the U.S. alone. As the population continues to age, this financial strain is expected to intensify, underscoring the need for more effective and accessible treatment options.

About BioRetain^®:
BioStem’s allografts are processed utilizing the Company’s proprietary BioRetain method, which maintains the tissue’s native components, including 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. For a full overview of BioRetain^®, please visit: HERE.

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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 are accredited by the American Association of Tissue Banks (“AATB”) and adhere to current Good Tissue Practices (cGTP) . 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.

For more information visit biostemtechnologies.com and follow us on X and LinkedIn.

Contact BioStem Technologies, Inc.:

Website: http://www.biostemtechnologies.com
E-Mail: info@biostemtech.com
X: @BSEM_Tech
Facebook: BioStemTechnologies
Phone: 954-380-8342

Investor Relations:
Philip Trip Taylor, Gilmartin Group
E-Mail: ir@biostemtech.com

Note Regarding Forward-Looking Statements:
Except for statements of historical fact, this press release also contains forward-looking statements. These forward-looking statements relate to expectations or forecasts of future events, including with respect to the operations of the Company, strategies, prospects and other aspects of the business of the Company. Forward-looking statements may be identified using words such as “forecast,” “intend,” “seek,” “target,” “anticipate,” “believe,” “expect,” “estimate”, “plan,” “outlook,” and “project” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. Forward-looking statements in this press release include, among other things, statements regarding: the Company’s expectations regarding clinical trial results, including the timing of enrollment and publication of data from such trials; the anticipated commercial benefits from such clinical trials; and the estimated addressable market growth for the Company’s products. Forward-looking statements are based on current expectations that are subject to known and unknown risks and uncertainties, which could cause actual results or outcomes to differ materially from the expectations expressed or implied by such forward-looking statements. These factors include, but are not limited to: the risk that clinical trials are not completed as planned or that the results are not as favorable as the Company expects; changes in the highly competitive market in which the Company operates; the risk of rapid technological change, which could cause the Company’s products to become obsolete, among other things; the risk that the Company may be unable to successfully market its products to the end users of such products; the risk that the Company may be unable to raise capital on terms acceptable to it, or at all, which could have a material adverse impact on the Company’s business, financial condition, and prospects; the impact of any changes to the accounting treatment of the Company’s revenue and expenses; the impact of any changes in applicable laws or regulations; and the possibility that the Company may be adversely affected by other general economic, business, and/or competitive factors. You are cautioned not to place undue reliance upon any forward-looking statements, which speak only as of the date made. The Company undertakes no commitment to update or revise the forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

FAQ

What were the primary BR-AC trial results for BioStem (BSEM) on Oct 31, 2025?

Top-line results showed 53% probability of lasting wound closure with BR-AC versus 31% with standard of care over 12 weeks.

How many patients and sites were in the BioRetain DFU trial (BSEM)?

The randomized trial enrolled 71 patients at 11 U.S. sites and began in Q4 2024.

What definition of closure did the BSEM BR-AC trial use?

The study used complete closure per the 2006 FDA guidance, requiring wounds to remain closed for 4 weeks to qualify as lasting closure.

Where were BioStem (BSEM) BR-AC results published?

Top-line results were published in the International Journal of Tissue Repair.

Will BioStem (BSEM) report more data from the BR-AC DFU study?

Yes; future publications will present secondary outcomes including time to closure, wound area/volume changes, and number of applications.

Does the Oct 31, 2025 BSEM announcement prove commercial benefit?

The announcement reports clinical benefit on a primary endpoint, but commercial impact and broader adoption remain to be demonstrated with additional data and market uptake.