Hemostatic Bioadhesive Paste for Coagulation-Independent Rapid Control of Bleeding

ABSTRACT The objective of this proposal is to optimize and validate the hemostatic bioadhesive paste 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 major hemorrhagic events in cardiovascular and other surgeries, various hemostatic agents have been developed and clinically tested. To date, however, there is no hemostatic solution that can achieve effective and rapid hemostasis in frequent and high-risk bleeding of patients under anticoagulation or coagulopathic settings due to the incompatibility of conventional coagulation-based hemostatic approaches. 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 hemostatic bioadhesive paste for rapid (within 10 s) coagulation- independent control of bleedings by uniquely utilizing the novel blood-resistant bioadhesive mechanism. The preliminary pre-clinical validation and analysis based on in vivo rat and porcine models demonstrated the promising hemostatic efficacy and underlying mechanism of the hemostatic bioadhesive paste for the bioadhesion-based coagulation-independent rapid control of bleedings. Building upon the promising outcome of the prior development, under the scope of this Direct-to-Phase II SBIR proposal, we will further optimize and validate the hemostatic bioadhesive paste in compliance with relevant FDA regulatory guidance for the highly effective and broadly affordable solution to treat high-risk bleeding in the anticoagulated or coagulopathic patients. 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.