Strain-Programmed Bioadhesive Patch for Enhanced Diabetic Wound Healing

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ABSTRACT The objective of this proposal is to optimize and validate the strain-programmed bioadhesive patch in compliance with FDA regulatory guidance for the FDA IDE approval in advance of the future pivotal clinical trial and ultimate regulatory clearance and commercialization. In light of the huge and rapidly growing clinical and economic costs of chronic diabetic wounds and associated complications, various treatments including skin scaffolds and growth- factor-based drugs have been proposed and clinically tested. To date, however, the existing approaches still face several limitations for diabetic wound healing including limited therapeutic efficacy and/or high cost of product/treatment. To address these limitations of existing solutions, during the prior development (Phase I- equivalent), our collaborative team developed a proof-of-concept prototype of a strain-programmed bioadhesive patch for enhanced diabetic wound healing by uniquely utilizing pro-regenerative mechanical modulation. The preliminary pre-clinical validation and analysis based on in vivo db/db mice, diabetic porcine, and diabetic humanized mice models revealed the promising therapeutic potential and underlying mechanisms of the strain- programmed bioadhesive patch for the accelerated healing of diabetic cutaneous wounds. Building upon the promising outcome of the prior development, under the scope of this Direct Phase II SBIR proposal, we will further optimize and validate the strain-programmed bioadhesive patch in compliance with relevant FDA regulatory guidance for the effective and broadly affordable treatment of chronic diabetic wounds such as DFU. If successful, the proposed project will allow SanaHeal to prepare and submit the FDA IDE package in advance to a pivotal clinical trial and ultimate commercialization with far-reaching benefits for patients and the healthcare system.