BioStem Receives Institutional Review Board (IRB) Approval to Advance Clinical Study Evaluating the Value of Vendaje® Compared to the Standard of Care for Non-Healing Diabetic Foot Ulcers

Rhea-AI Summary

BioStem Technologies Inc. (OTC: BSEM) has received Institutional Review Board (IRB) approval for a clinical study evaluating Vendaje® against standard care for non-healing diabetic foot ulcers (DFUs). The study aims to accelerate product adoption by providing data to healthcare professionals and payers on Vendaje's benefits. Vendaje is a placental-derived allograft using BioStem's proprietary BioREtain technology.

The multi-center, randomized, controlled study will assess the percentage of subjects achieving complete wound closure within 12 weeks as its primary endpoint. Secondary endpoints include time to closure, percent change in wound area, and total applications used. This research supports BioStem's growth strategy and aims to secure broader payer coverage, including Medicare.

Positive

• IRB approval received for clinical study of Vendaje® for diabetic foot ulcers
• Study aims to accelerate product adoption and secure broader payer coverage
• Vendaje® is already reimbursed through Medicare
• Trial designed to provide real-world data on Vendaje's efficacy compared to standard care

Negative

• None.

Study supports BioStem’s strategic growth initiatives and accelerates product adoption by providing data to healthcare professionals and payers on the benefits of Vendaje

POMPANO BEACH, Fla., Aug. 21, 2024 (GLOBE NEWSWIRE) -- BioStem Technologies Inc. (OTC: BSEM), a leading MedTech company focused on the development, manufacture, and commercialization of placental-derived biologics for advanced wound care, announces that the Institutional Review Board (IRB) has approved a clinical study to evaluate Vendaje^® for diabetic foot ulcers (DFU), a key product in the company’s placental-derived allograft portfolio. This study aims to assess the efficacy of Vendaje compared to standard of care in diabetic patients with non-healing DFU’s, providing critical data to support both patient outcomes and payer decisions.

Jason Matuszewski, CEO of BioStem, stated, "This study supports BioStem’s strategic growth initiatives and aims to accelerate product adoption by providing real-world data to healthcare professionals and payers like Medicare on the benefits and value of Vendaje. Our primary goal with these studies is to secure broader payer coverage and increase patient access to Vendaje. With our proprietary BioREtain technology, we deliver a superior product for treating diabetic foot ulcers. We look forward to advancing these trials and will provide regular updates as patient enrollment and treatment progress.”

Vendaje is a placental-derived, minimally manipulated dehydrated tissue allograft that serves as a protective covering for soft tissue wounds. Composed of the amnion layer of the placenta, the product naturally possesses extracellular matrix scaffolding that provides mechanical protection and functional support for cell attachment, growth factors that help modulate proliferation and angiogenesis, and anti-inflammatory cytokines that inhibit inflammatory effects, all critical in aiding the body’s natural healing cascade. The product is used in private office and hospital/surgical settings, and which is currently reimbursed through Medicare.

Vendaje Trial Overview:
This trial is a multi-center, randomized, controlled study of non-healing DFUs treated with standard of care with or without Vendaje. The primary endpoint of the study is the percentage of subjects whose target ulcer achieve complete wound closure within 12 weeks. Secondary endpoints comparing differences between treatment groups include the time to closure, percent change in wound area and volume at 12-weeks, total number of applications used to achieve complete wound closure, and time to closure for subjects that crossover. The safety endpoint will evaluate spontaneously reported and elicited adverse events, and the exploratory endpoint will assess the differences between treatment groups in clinical signs and symptoms of infection.

Diabetic Foot Ulcers Market Facts:
Diabetic Foot Ulcers are a significant risk for people with diabetes. According to the American Podiatric Medical Association (APMA), a leading resource for foot and ankle health, approximately 15 percent of people with diabetes develop foot ulcers. Of those 15 percent, six percent go on to be hospitalized due to infection or other ulcer-related complications. The risk to patients with diabetes is significant, as it is the leading cause of lower extremity amputations in the U.S. Approximately 14 to 24 percent of people with diabetes that develop foot ulcers will require an amputation. These ulcers pose a significant economic strain on healthcare systems, with annual treatment costs estimated to range from $9 to $13 billion in the United States alone.

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 regenerative therapies. 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 regenerative medicine, 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 purpose of BioStem's (BSEM) clinical study for Vendaje®?

The clinical study aims to evaluate the efficacy of Vendaje® compared to standard care for non-healing diabetic foot ulcers (DFUs), providing data to support patient outcomes and payer decisions.

What is the primary endpoint of BioStem's (BSEM) Vendaje® trial for DFUs?

The primary endpoint is the percentage of subjects whose target ulcer achieves complete wound closure within 12 weeks.

How does Vendaje® work in treating diabetic foot ulcers for BioStem (BSEM)?

Vendaje® is a placental-derived allograft that provides mechanical protection, functional support for cell attachment, growth factors for proliferation and angiogenesis, and anti-inflammatory cytokines to aid the body's natural healing process.

What is the market potential for BioStem's (BSEM) Vendaje® in treating diabetic foot ulcers?

Approximately 15% of people with diabetes develop foot ulcers, with annual treatment costs estimated at $9-$13 billion in the US alone, indicating a significant market potential for effective treatments like Vendaje®.