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HELical Biodegradable Photochemical(HELP)Stents for AVF Maturation

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41DK111332-01
Agency Tracking Number: R41DK111332
Amount: $275,529.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: 300
Solicitation Number: PA15-270
Solicitation Year: 2015
Award Year: 2016
Award Start Date (Proposal Award Date): 2016-09-15
Award End Date (Contract End Date): 2019-08-31
Small Business Information
1776 MENTOR AVE, STE 530
Cincinnati, OH 45212-3647
United States
DUNS: 080090144
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (520) 626-6371
Business Contact
Phone: (520) 626-6371
Research Institution

Although arteriovenous fistulae AVFs are the preferred mode of dialysis vascular access over fail to
mature in that they do not develop an adequate blood flow or diameter to support hemodialysis This results
in a very significant clinical morbidity and economic cost At a pathogenetic level AVF maturation failure is due
to a small vessels b bad non laminar hemodynamic profiles that likely result in a more aggressive
stenosis due to endothelial cell dysfunction and c abnormal baseline vascular biology due to uremia and
oxidative stress
The central hypothesis for this proposal is that the placement of a HELical biodegradable Photochemically
etched HELP stent at the time of AVF creation will a dilate small veins b create good hemodynamics
through the generation of spiral laminar flow c have the future potential to optimize local uremic vascular
biology through selected coatings drugs cells or chemicals and so help with AVF maturation
We plan to address this central hypothesis through a series of specific aims that focus on a fabrication of
HELP stents that have an optimized flow profile in vitro Specific Aim Engineering Aim b demonstration
of in vivo degradation and toxicity profiles Specific Aim Biocompatibility and Toxicity Aim c in vivo proof
of principle experiments to document therapeutic efficacy flow and diameter Specific Aim Therapeutic
In summary there is clearly a huge and unmet clinical need for novel therapies to enhance AVF maturation
there are currently no effective therapies for this In addition the innovative photochemical technology
described in this proposal lends itself to mass production and subsequent economies of scale As a result we
strongly believe that the HELP stent is an important platform technology that could deliver improved patient
outcomes at reduced cost thus adding overall value to the care of hemodialysis patients NARRATIVE
Although arteriovenous fistulae AVFs are the preferred mode of permanent dialysis vascular access they
have huge problems with AVF non maturation failure to adequately increase flow and diameter to support
dialysis We believe that the HELP stent has the potential to significantly enhance AVF maturation thus
resulting in improved clinical outcomes at a reduced cost increased value in the care of hemodialysis

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

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