Tailored Medical Devices Inc. — Department of Health and Human Services SBIR Phase I: NHLBI

Description

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