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

Rhea-AI Summary

BioStem Technologies (OTC: BSEM) has completed enrollment of 71 patients in its clinical trial evaluating BioREtain Amnion Chorion (BR-AC) for treating diabetic foot ulcers (DFUs). The multicenter, randomized controlled trial, initiated in Q4 2024 across 11 U.S. sites, aims to demonstrate superior wound healing compared to standard care over 12 weeks. Topline results are expected in Q4 2025. The study is part of three ongoing clinical trials for BioREtain-processed allografts. The DFU market represents a significant opportunity, with 2.2 million patients treated in 2023 and annual treatment costs between $9-13 billion in the U.S. According to APMA, approximately 15% of diabetic patients develop foot ulcers, with 14-24% potentially requiring amputation.

Positive

• Successful completion of patient enrollment with 71 patients, exceeding the minimum target of 60 patients
• Company is advancing three concurrent clinical trials to validate BioREtain technology
• Large market opportunity with 2.2 million DFU patients treated in 2023
• Company's products are FDA registered and AATB accredited

Negative

• Results of the clinical trial won't be available until Q4 2025
• Company trades on OTC markets rather than major exchanges
• Faces competition in the advanced wound care market

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: HERE

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: HERE.

Join BioStem’s Distribution List & Social Media:
To stay informed on the latest developments, sign-up for the Company’s email distribution list HERE, and follow us on X and LinkedIn.

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.

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

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

Investor Relations:
Adam Holdsworth
E-Mail: adam@biostemtech.com
Phone: 917-497-9287

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: ability to clear all current SEC comments; expectations regarding filing an amended Form 10, including the timeframe therefor and the content therein; and expectations regarding the Company’s plan and ability to satisfy Nasdaq listing requirements. 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 the Company may be unable to list its stock on Nasdaq or maintain compliance with Nasdaq’s continued listing standards; the impact of any changes to the accounting treatment of the Company’s revenue and expenses; the risk of receiving additional comments from the SEC; the competition that the Company faces, which could adversely affect its business, results of operations and financial condition; the risk of rapid technological change, which could cause the Company’s products to become obsolete or cause the Company to become unable to effectively compete; the risk that the Company is unable to successfully market its products to the end users of such products; the risk that the Company may be unable to raise funds to expand its business; changes in applicable laws or regulations; and the possibility that the Company may be adversely affected by other 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 is the primary objective of BioStem's (BSEM) BR-AC-DFU-101 clinical trial?

The primary objective is to determine if diabetic foot ulcers treated with standard care plus BR-AC achieve higher probability of complete wound closure over 12 weeks compared to standard care alone.

How many patients were enrolled in BioStem's (BSEM) diabetic foot ulcer clinical trial?

BioStem enrolled 71 patients across 11 U.S. sites, exceeding their minimum target of 60 patients.

When will BioStem Technologies (BSEM) report the results of their BR-AC DFU trial?

Topline results from the clinical trial are expected to be reported during the fourth quarter of 2025.

What is the market size for diabetic foot ulcer treatments?

According to GlobalData Plc., 2.2 million patients received treatment for DFUs in 2023, with annual treatment costs estimated between $9-13 billion in the United States.

What is BioStem's BioREtain technology used for?

BioREtain is a proprietary six-step processing method that retains tissue's native properties while maintaining the structure and matrix found in fresh perinatal tissue for wound treatment.