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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: 2R44DK108488-04A1
Agency Tracking Number: R44DK108488
Amount: $2,999,008.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: 400
Solicitation Number: PA19-273
Solicitation Year: 2019
Award Year: 2020
Award Start Date (Proposal Award Date): 2020-09-15
Award End Date (Contract End Date): 2023-06-30
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: (813) 902-2228
Research Institution

End Stage Renal Disease (ESRD) affects more 750,000 individuals in the United States alone. Hemodialysis
(HD) is a life-sustaining therapy for patients suffering from renal failure that requires blood to be withdrawn and
cycled through a dialysis machine. This process requires repeated needle punctures and the consequent needle
access to a surgically created vascular shunt. These shunts are often created by connecting an artery to a vein
with a prosthetic synthetic conduit (arteriovenous graft [AVG]); these grafts, though widely used, suffer from
many disadvantages. First, they do not allow for immediate cannulation as they require an initial period of 4
weeks for tissue incorporation and healing post implant. Thus, more than 85% of ESRD patients initiate HD via
tunneled dialysis catheter (TDC) while their AVG heals. Because TDCs are associated with high morbidity and
mortality rates, the prospect of an AVG that can be cannulated immediately post implantation may reduce
morbidity in these patients. Second, HD access injuries caused by careless or poor cannulation practices can
result in graft material degradation, pseudoaneurysm formation, bleeding, clots, and infections. There is no
currently available AVG that offers immediate cannulation after implantation, facilitates successful, error-proof
needle entry, and protects from access cannulation injury. To reduce these complications, InnAVasc Medical,
Inc. has developed an immediate access hemodialysis graft that is deigned to assure routine, successful
cannulation, prevents graft injury, and thus, could promote safer home HD; the Bullet Proof vascular graft (BPG).
This graft is constructed of biocompatible materials and is designed to be immediately hemostatic, self-sealing
and resistant to inadvertent posterior and sidewall needle penetration. In the Phase II project and early feasibility
clinical study, we confirmed the BPG could be successfully implanted in all subjects and that the device was well
tolerated. Furthermore, the cannulation chamber worked as intended to allow for immediate access and prevent
needle-related injuries. However, due to a lack of adequate strain relief at the soft graft to chamber transition
zones, there was a higher rate of early graft thrombosis than clinically acceptable. We have tested the revised
graft on the bench compared to the original BPG and it outperforms the original in all aspects of luminal integrity.
Furthermore, clinical data from a small feasibility study in South America confirmed the new strain relief
prevented early thrombosis. Therefore, we are confident that the revised BPG will perform as expected in terms
of function, flow, and patency in the next planned clinical study. In this Phase IIB, we will further the commercial
development of the revised BPG and achieve our specific goal of the project by conducting a pivotal clinical
study to evaluate its safety and effectiveness for HD access in subjects with ESRD. This will be a prospective,
multicenter, single arm, clinical study conducted at seven sites in the US with a planned enrollment of 60 subjects
with ESRD. A 510(k) application will be submitted to the US Food and Drug Administration with six months of
patient follow-up as the primary analysis.

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

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