Innavasc Medical, Inc. — Department of Health and Human Services SBIR Phase II: 400

Description

PROJECT SUMMARY End Stage Renal DiseaseESRDis a complex disease that involves total and permanent kidney failure that affects moreindividuals in the United States aloneHemodialysis is a life sustaining therapy for patients suffering from renal failure that requires that blood be withdrawn and cycled through a dialysis machine that performs the function of the failed kidneysThis process must be repeated at regular intervals and thus requires repeated needle punctures and the consequent needle access to a surgically created vascular shuntThese shunts are often created by connecting an artery to a vein with a prosthetic graftarteriovenous graftAVGthese graftsthough widely usedsuffer from many disadvantagesFirstthey do not allow for immediate cannulation and use in dialysisas they require an initial period for tissue incorporation and healing post implantThusmore thanof ESRD patients start dialysis via tunneled dialysis catheterTDCfor long periods while their AVG healBecause TDCs are associated with a high morbidity and mortality ratesthe use of an AVG that can be cannulated immediately after implantation may reduce morbidity in these patientsSecondhemodialysis access injuries due to poor cannulation can result in aneurysmsclotted accessand infectionsThere is no AVG currently available that offers immediate cannulation after implantationfacilitates successfulerror proof needle entryand protects from access cannulation injuryTo reduce the incidence of needle cannulation injuries and associated complications such as graft thrombosis and aneurysmsInnAVasc MedicalInchas developed an immediate access hemodialysis graft that assures routinesuccessful cannulation and prevents graft injurythe Bullet Proof vascular graftThis graft is constructed of biocompatible materials and has been designed to be easily identifiableimmediately hemostaticself sealing and resistant to posterior and sidewall penetrationPreliminary data has shown extreme promisedemonstrating ease of safeerror proofand immediate cannulationand a dramatic reduction in time to hemostasis following needle removalIn this Phase II proposalwe will further the commercial development of the Bullet Proof graft by conducting biocompatibility and GLP animal studies with the final device as might be required for submission of an IDE to the FDA as well as conduct a first in man feasibility studyThe specific goals of this study arePerform biocompatibility testing to evaluate the chemical and material safety of the Bullet Proof graftAssess the consistencyreproducibility and reliability of the Bullet Proof graft using a GLP animal studyandConduct a first in man feasibility study in a limited and controlled human cohort to demonstrate that the product can perform for its intended purpose as a vascular access graftSuccessful completion of these Phase II SBIR studies will allow us to submit for regulatory clearance for the finalized deviceaggressively seek a viable and strategic partnershipand proceed with commercialization plans in the US and EU