CRITICAL INNOVATIONS LLC — Department of Defense SBIR Phase II: DHA16-011

Description

Defense Health Program (DHP)seeks to develop a new and innovativemedical devicetailored to prevent or treat accumulation of blood in the pleural space afterchest trauma or surgery (i.e.retained hemothorax). Critical Innovations; NeoMatRx;Milestone Strategies; OHSU School of Medicine; and, KARA & Associates, in addition to consultant Captains David Plurad,MD,FACS (USN, Ret.) and David Tanen,MD,FAAEM,FACMT (USN, Ret.), haveformed a team ofmedical deviceexperts to address this important medical need. Under PhaseI,we developed a fullyfunctional prototype(TRL4) that surpassed all initial requirements and preclinical testing. During PhaseII, theteam will develop the PleuraPath™ system into amanufacture-ready device with demonstrated safety and efficacy (TRL7). This will includerefiningthecurrent prototype using an agile human factorsengineering approach (TRL5);readyingthesystem for full manufacture(TRL6); demonstratingsafety and efficacy in live animalexperiments (TRL7); and,maintenance of regulatory compliancein conjunction with an FDA submission. Theresult of the PhaseII project will be a well-tested system poised for transition and commercialization to military and civilian markets.