ARSENAL MEDICAL INC — Department of Health and Human Services SBIR Phase I: 300

Description

DESCRIPTION provided by applicant Significance Traumatic pelvic bleeding is a significant cause of morbidity and mortality and many patients die from potentially survivable injuries These injuries claim up to lives every year in the United States This fact highlights an emergent need for innovative technologies to control bleeding in the most severely injured patients Approach This FastTrack SBIR application will develop novel self expanding polyurethane foam systems for treatment of exsanguinating pelvic hemorrhage In Phase I of the proposal Arsenal Medical will collaborate with Massachusetts General Hospital MGH to create a novel clinically relevant animal model of pelvic hemorrhage A trimodal approach incorporating vascular injury soft tissue injury and tissue disruption will be utilized To estabish baseline performance and areas for optimization existing treatments will be tested including Arsenal Medicalandapos s ResQFoam technology designed for intraabdominal use In Phase II of the proposal a foam will be developed for efficacy and removal in the pelvic space by modulating open cell microstructure and improving foam mechanical properties tensile strength elasticity of the polyurethane struts The appropriate dose of this self expanding foam for effectiveness in pelvic bleeding will be determined through a dose ranging study The net result will be an effective biomaterial intervention for treatment of pelvic bleeding After optimizing the foam a comprehensive physiological study of ischemia reperfusion dynamics will be conducted Phase II will culminate in the preparation of a preliminary regulatory submission to the FDA Innovation The trauma community lacks a robust animal model for the assessment of therapeutics surgical approaches and devices for the treatment of pelvic hemorrhage Establishing this animal model as well as critical research in ischemia reperfusion injuries will provide substantial benefit to the trauma community Self expanding foam treatment will be effectively developed for clinical use in retroperitoneal pelvic bleeding based on the aims of this proposal resulting i a new life saving therapy An established productive interdisciplinary team established regulatory pathway and existing manufacturing infrastructure increase the probability of success and commercialization of self expanding foams for pelvic trauma The proposed research will develop the first closed cavity lethal model of pelvic exsanguination and create a minimally invasive foam platform for pelvic hemostasis that will be superior to the existing standard of care PUBLIC HEALTH RELEVANCE The goal of this SBIR proposal is to develop a novel animal model for exsanguinating pelvic hemorrhage and develop a self expanding polyurethane foam system to treat this injury This project will advance basic science and will lead to the development o a novel lifesaving clinical device