BioStem (BSEM) Obtains Institutional Review Board (IRB) Approval to Advance Clinical Study Utilizing AmnioWrap2™ to Treat Diabetic Foot Ulcers
A leader in regenerative medicine, BioStem Technologies (BSEM) announced the IRB has approved a clinical study to evaluate AmnioWrap2™ (AW2) in diabetic foot ulcers (DFU), one of the company’s placental-derived allograft commercial products. BioStem focuses on developing, manufacturing and commercializing placental-derived biologics for advanced would care that addresses diabetic foot ulcers, a critical health issue which can lead to lower limb amputations, illness and death in diabetic patients.
Upon the study’s completion, BioStem intends to commercially advance AW2 with expanded Payer Insurance Coverage related to the diabetic foot ulcer market. Due to DFU’s prevalence and severe complications associated, a significant economic strain exists on healthcare systems as annual treatment costs can range from approximately $9Bn-$13Bn in the United States.
Jason Matuszewski, CEO of BioStem, commented: “The medical community is constantly seeking new treatments to prevent or lessen these complications and their considerable impact on patients, families, and the healthcare system as a whole. Our clinical team has developed a novel, standardized clinical trial protocol utilizing advanced technologies to ensure the collection of high-quality data. The diabetic foot ulcer patient population stands to benefit significantly from our advanced wound care technologies. Through this innovative trial, we aim to demonstrate the efficacy of our unique AW2 allograft, manufactured with our patented BioREtain™ technology.”
As it relates to the AW2 Trial, the primary endpoint will be the percentage of subjects whose target ulcer achieve complete wound closure within 12 weeks. AW2 consists of unseparated amnion and chorion membranes, including the intact intermediate layer and is a minimally manipulated dehydrated tissue allograft that serves as a protective covering for soft tissue wounds. AW2’s breakthrough results from a wound care study have also been published in the international, peer-reviewed journal, Health Science Reports.
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.
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