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BioStem Receives Institutional Review Board (IRB) Approval to Advance Clinical Trial Demonstrating the Therapeutic Benefits of BioREtain® Technology in Treating Venous Leg Ulcers
Study comparing BioStem’s proprietary amnion chorion allograft versus the standard of care aims to demonstrate superior outcomes, further validating its clinical efficacy to support market expansion
POMPANO BEACH, Fla., Feb. 24, 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 Institutional Review Board (IRB) approval for a clinical study to evaluate its proprietary BioREtain® Amnion Chorion (BR-AC) for the treatment of venous leg ulcers (VLU). This study aims to assess the efficacy of BR-AC compared to standard of care in patients with non-healing VLUs, providing critical data to support continued market adoption of its proprietary technology.
Jason Matuszewski, CEO of BioStem, stated: "This is our third prospective clinical trial across various wound indications, and we continue to advance these trials for our allograft products with the goal of demonstrating clinical superiority for healthcare professionals and payers. We previously announced the publication of a peer-reviewed study demonstrating breakthrough results with the application of this product for diabetic foot ulcers. BioStem is confident that the benefits of our technology will become evident in additional indications such as VLUs and looks forward to providing updates as the trial progresses.”
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.
BR-AC consists of unseparated amnion and chorion membranes, including the intact intermediate layer. It contains collagen, extracellular matrix, and a wide array of protein components including growth factors, cytokines, and chemokines. BR-AC is a minimally manipulated dehydrated tissue allograft that serves as a protective covering for soft tissue wounds.
BR-AC-VLU Clinical Trial Overview and Design:
Title: Non-healing Venous Leg Ulcers Treated with Standard Care, With or Without BR-AC
Primary Outcome Measures: The primary objective of this study is to assess whether the addition of BR-AC increases the likelihood of achieving complete wound closure in venous leg ulcers (VLUs) compared to standard of care alone. The study will evaluate the proportion of subjects who achieve full wound closure, defined as 100% re-epithelialization, over a 12-week treatment period.
The BR-AC-VLU trial is a multicenter, randomized, controlled study that will enroll at least 60 subjects with a non-healing VLU at approximately 15 sites across the United States. The study will focus on a patient population with non-healing, non-infected VLUs having confirmed venous reflux by duplex Doppler ultrasound. All consented subjects will enter a two-week run-in period receiving only standard wound care. Those who comply with compression therapy, have not healed greater than 30% and continue to meet criteria after two-weeks will be randomized in a 1:1 fashion. Weekly study visits will be conducted to monitor compliance with wound care protocols and compression therapy, 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.
Venous Leg Ulcers Facts: Venous leg ulcers are chronic sores that develop on the legs due to poor blood flow in the veins and affect up to two million people in the United States annually. The venous leg ulcer market, focused on the treatment and management of these ulcers, is growing at a CAGR of more than 4%, driven by the growing prevalence of this condition, increasing awareness about treatment options, and advancements in wound care technologies like compression therapies and bioengineered dressings. The market is projected to see significant growth due to the aging population and rising chronic disease rates, with estimates suggesting a market size reaching several billion dollars in the coming years.
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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. 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.
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