BioStem Technologies Launches Clinical Trial to Demonstrate the Therapeutic Benefits of its BioREtain® Technology in Treating Diabetic Foot Ulcers Using Vendaje®

Rhea-AI Summary

BioStem Technologies (OTC: BSEM) has launched the BR-AM-DFU clinical trial to evaluate its Vendaje® product against standard care for treating non-healing diabetic foot ulcers (DFUs). The multicenter, randomized study will enroll 60 patients across twelve U.S. sites, assessing wound closure over a 12-week treatment period.

This marks the company's second active clinical trial, following the BR-AC-DFU-101 trial initiated in October 2024 for AmnioWrap2™. The trials aim to demonstrate the effectiveness of BSEM's proprietary BioREtain® technology in wound care. According to market statistics, approximately 15% of diabetic patients develop foot ulcers, with treatment costs ranging from $9-13 billion annually in the U.S. In 2023, 2.2 million patients received DFU treatment.

Positive

• Launch of new clinical trial to validate Vendaje® effectiveness
• Second active clinical trial showing pipeline progress
• Large addressable market with 2.2M DFU patients treated in 2023
• Significant market opportunity with $9-13B annual treatment costs in U.S.

Negative

• Product still requires clinical validation despite being commercially available
• Extended timeline for trial completion with 12-week treatment period plus follow-up
• Relatively small trial size of 60 patients

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.

Join BioStem’s Distribution List & Social Media:
To follow the latest developments at BioStem, sign-up to the Company’s email distribution list HERE, and follow us on Twitter 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. 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 Technologies’ quality management system and standard operating procedures have been reviewed and accredited by the American Association of Tissue Banks (“AATB”). These systems and procedures are established per current Good Tissue Practices (“cGTP”) and current Good Manufacturing Processes (“cGMP”). Our portfolio of quality brands includes AmnioWrap2™, VENDAJE^®, VENDAJE AC^®, and VENDAJE OPTIC^®. 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 Twitter and LinkedIn.

Forward-Looking Statements:
Except for statements of historical fact, this release also contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements relate to expectations or forecasts of future events. 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 with respect to the operations of the Company, strategies, prospects and other aspects of the business of the Company 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 expectations expressed or implied by such forward-looking statements. These factors include, but are not limited to: (1) the impact of any changes to the reimbursement levels for the Company’s products; (2) the Company faces significant and continuing competition, which could adversely affect its business, results of operations and financial condition; (3) rapid technological change could cause the Company’s products to become obsolete and if the Company does not enhance its product offerings through its research and development efforts, it may be unable to effectively compete; (4) to be commercially successful, the Company must convince physicians that its products are safe and effective alternatives to existing treatments and that its products should be used in their procedures; (5) the Company’s ability to raise funds to expand its business; (6) the Company has incurred significant losses since inception and may incur losses in the future; (7) changes in applicable laws or regulations; (8) the possibility that the Company may be adversely affected by other economic, business, and/or competitive factors; (9) the Company’s ability to maintain production of its products in sufficient quantities to meet demand; and (10) the COVID-19 pandemic and its impact, if any, on the Company’s fiscal condition and results of operations; You are cautioned not to place undue reliance upon any forward-looking statements, which speak only as of the date made. Although it may voluntarily do so from time to time, 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 applicable securities laws.

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

PCG Advisory
Jeff Ramson
jramson@pcgadvisory.com
646-863-6893

FAQ

What is the primary objective of BSEM's BR-AM-DFU clinical trial?

The primary objective is to assess if Vendaje® combined with standard care increases complete wound closure rates in diabetic foot ulcers compared to standard care alone over a 12-week treatment period.

How many patients will be enrolled in BSEM's new DFU clinical trial?

The BR-AM-DFU trial will enroll 60 patients across approximately twelve sites in the United States.

What is the market size for diabetic foot ulcer treatment that BSEM is targeting?

In 2023, 2.2 million patients received treatment for diabetic foot ulcers, with annual treatment costs estimated between $9-13 billion in the United States.

How many active clinical trials does BSEM currently have for diabetic foot ulcers?

BSEM has two active clinical trials: the newly launched BR-AM-DFU trial for Vendaje® and the BR-AC-DFU-101 trial for AmnioWrap2™ initiated in October 2024.

What percentage of diabetic patients develop foot ulcers according to BSEM's market data?

According to the American Podiatric Medical Association, approximately 15% of people with diabetes will develop foot ulcers.