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Multi-release drug-coated balloons for the treatment of peripheral artery disease with long, diffuse, and multiple lesions

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R43HL142449-01A1
Agency Tracking Number: R43HL142449
Amount: $225,000.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: NHLBI
Solicitation Number: PA17-302
Solicitation Year: 2017
Award Year: 2018
Award Start Date (Proposal Award Date): 2018-09-01
Award End Date (Contract End Date): 2019-08-31
Small Business Information
Sioux Falls, SD 57105-6941
United States
DUNS: 080694312
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (605) 201-6739
Business Contact
Phone: (605) 940-7275
Research Institution

Project Summary Abstract
Peripheral artery diseasePADaffects overmillion people worldwide and can result in life threating
complicationsCurrentlydrug coated balloonsDCBsare used to treat lesions in the peripheral arteriesHowevercommercially available DCBs are designed to treat only a single blockage siteIn PAD patientscomplex lesions involving longdiffuseand or multiple blockages are often found resulting in the use of
multiple DCBsWith each DCB being very expensive and the procedure time consumingthere is a need in the
market for a multiple release DCB that can release the drug at multiple arterial locations which can reduce the
number of DCBs needed for a procedureThis will ultimately result in the reduction of costtimeand
complications of DCB procedures involving complex lesionsA single release DCB was recently developed by Tailored Medical DevicesIncusing polyethylene
oxidePEOas a platform to control the release of the drug paclitaxelPATThe developed PEO balloon has
shown to be safe and effective in a pre clinical setting for the treatment of a single blockageWith modifications
in the single release PEO balloon formulation and coating strategya multiple release PEO DCBMR PEODCBhas been developedA recent pilot study showed that equivalent drug uptake and retention can be
achieved in two arteries using a MR PEO DCBThe goal of this project is to develop a sterile and
biocompatible MR PEO DCB that can deliver PAT for the treatment of complex lesions and investigate the
reproducibility of the drug retention in two different arterial locations for up todays using a porcine modelSpecific AimDevelop reproducible and sterile MR PEO DCBs in a cGMP facility
The MR PEO DCBs will be developed in a GMP facility through the use of sterile instruments and solutions
used to produce the formulationsThe physicalthermalchemicaland drug release properties of the MRPEO DCB coating will be tested using imagingcalorimetric techniquesand an established in vitro flow modelThe developed devices will then be tested for sterility according to established USP testing methodsSpecific AimTest the cytotoxicity and hemocompatibility of the MR PEO DCB
The cytotoxicity and hemocompatibility testing will be conducted as per the FDA guidelines for the short
exposureandlthblood circulation devicesCyotoxicityhemolysisand complement activation will be
assessed by the exposure of the device or its extracts to the appropriate cell linesSpecific AimTest the drug retention and plasma drug levels after MR PEO DCB treatments in vivo
In vivo swine studies will be performed to test the reproducibility of drug retention at dayand dayA successful outcome of this proposal will be to develop a sterile and biocompatible multiple release
DCB that can obtain therapeutic and equivalent amounts of drug in two arterial locationsFuture phase II
studies would include long term animal studies on tissue retention and healing responses Project Narrative
Peripheral artery disease is frequently associated with complex lesions including longdiffuseand or multiple blockages that currently requires the use of two or more drug coated balloonsDCBsfor treatmentWe have identified a formulation and coating strategies that allows for a
safe and effective treatment of these lesionsIn this projectwe propose to develop a multirelease DCB that will be able to treat these complex lesions with the use of a single DCB to
provide a safercheaperand less complicated alternative to the currently used methods

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

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