BioStem Receives Institutional Review Board (IRB) Approval to Advance Clinical Trial in Treatment of Venous Leg Ulcers

BioStem Technologies (BSEM) announced IRB approval for a clinical study evaluating its BioREtain® Amnion Chorion (BR-AC) technology for treating venous leg ulcers (VLU). The study will compare BR-AC to standard care in non-healing VLU patients to support market adoption.
BR-AC is a minimally manipulated tissue allograft designed to promote wound healing. The multicenter, randomized trial will enroll at least 60 patients across 15 U.S. sites, assessing wound closure rates over 12 weeks. The VLU market is expanding due to an aging population and increasing chronic disease prevalence, with significant growth potential.
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 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 AmnioWrap 2 ™, 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 .
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