BioStem Receives Institutional Review Board (IRB) Approval to Advance a Clinical Study Evaluating AmnioWrap2™ in Diabetic Foot Ulcers
BioStem Technologies (OTC: BSEM) has received Institutional Review Board (IRB) approval for a clinical study of AmnioWrap2™ (AW2) in treating diabetic foot ulcers (DFU). DFU is a severe complication of diabetes, leading to amputations and high healthcare costs. The study aims to evaluate the efficacy of AW2, targeting complete wound closure within 12 weeks. Secondary endpoints include time to closure, reduction in wound area and volume, and safety assessments. BioStem’s AW2 uses BioREtain™ technology, which includes unseparated amnion and chorion membranes. This trial follows promising retrospective results published in Health Science Reports. Upon successful completion, BioStem plans to seek expanded payer insurance coverage for AW2 in the DFU market.
- IRB approval for AW2 trial in diabetic foot ulcers.
- AW2 targets complete wound closure within 12 weeks.
- Promising retrospective results published in Health Science Reports.
- Potential for expanded payer insurance coverage post-trial.
- None.
POMPANO BEACH, Fla., July 10, 2024 (GLOBE NEWSWIRE) -- BioStem Technologies Inc. (OTC: BSEM), a leading regenerative medicine company focused on the development, manufacture, and commercialization of placental-derived biologics for advanced wound care, announces that 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.
Jason Matuszewski, CEO of BioStem, commented: “Diabetic foot ulcers are a critical health issue and can lead to lower limb amputations, illness and death in diabetic patients. 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.”
Following the completion of this study, BioStem will aim to commercially advance AW2 with expanded Payer Insurance Coverage within the diabetic foot ulcer market. Diabetic foot ulcers are among the most prevalent and severe complications affecting the lower extremities in individuals with diabetes mellitus. These ulcers pose a significant economic strain on healthcare systems, with annual treatment costs estimated to range from
AW2 Trial Overview:
BioStem has received IRB approval to proceed with the clinical study evaluating AW2 in patients with diabetic foot ulcers. 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.
AW2 consists of unseparated amnion and chorion membranes, including the intact intermediate layer. The allografts contain collagen, extracellular matrix, and a wide array of regulatory proteins such as growth factors, cytokines, and chemokines. AW2 is a minimally manipulated dehydrated tissue allograft that serves as a protective covering for soft tissue wounds.
BioStem recently announced breakthrough results using AmnioWrap2 in a retrospective wound care study. The article was published in the international, peer-reviewed journal, Health Science Reports, and validated its proprietary processing method and its placental allograft products. The article, titled Assessing placental membrane treatment efficiency in diabetic foot ulcers: Processing for retention versus lamination, provides a retrospective analysis of wound care in 41 subjects, and can be read HERE.
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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BioStem Technologies, Inc.
Phone: 954-380-8342
Website: http://www.biostemtechnologies.com
E-Mail: info@biostemtech.com
Twitter: @BSEM_Tech
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FAQ
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