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A Bullet Proof vascular graft to prevent dialysis access cannulation injury

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2R44DK108488-02
Agency Tracking Number: R44DK108488
Amount: $1,998,507.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: 400
Solicitation Number: PAR17-034
Solicitation Year: 2017
Award Year: 2017
Award Start Date (Proposal Award Date): 2017-09-18
Award End Date (Contract End Date): 2019-08-31
Small Business Information
Research Triangle Park, NC 27709-0003
United States
DUNS: 079093046
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (813) 902-2228
Business Contact
Phone: (510) 521-0100
Research Institution

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patients suffering from renal failure that requires that blood be withdrawn and cycled through a dialysis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

* Information listed above is at the time of submission. *

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