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.
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