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Novel Biological Tissue for Vascular Patch

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R43HL140763-01A1
Agency Tracking Number: R43HL140763
Amount: $419,085.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: NHLBI
Solicitation Number: PA17-302
Timeline
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
11107 ROSELLE ST, STE 213
San Diego, CA 92121-1206
United States
DUNS: 804419740
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 ADITYA PANDIT
 (858) 249-7404
 apandit@3dtholdings.com
Business Contact
 GHASSAN KASSAB
Phone: (858) 249-7400
Email: gkassab@3dtholdings.com
Research Institution
N/A
Abstract

ABSTRACT
Arterial and venous reconstructions are frequently needed to reestablish circulation in various diseasesorgan
transplantationsinterventional operationstraumaetcAutologous graftsmostly saphenous veinsare the gold
standard for vascular patches to reconstruct arteries and veinsThe disadvantages of autologous venous
patcheshoweverare obviousincluding multiple surgerieslimitations on dimensions and numbers of donor
sitesand donor complicationsSynthetic and biological materials are used to supplement autologous patches
in clinical practice but have a number of shortcomingsSynthetic patches have relatively high rate of occlusion
and risk of pseudoaneurysm formation and infection which may require life long follow up in susceptible
populationsBiological materials have been used to reconstruct arteries and veins with variable outcomes which
suggest the need for further refinementIn this Phase I SBIR proposalwe propose to evaluate the pulmonary
visceral pleuraPVPas a biological patch for reconstruction of arteries and veins in vascular surgeryThe PVP
plays an important role in lung functionand is inherently compliant and non thrombogenicOur preliminary data
show that glutaraldehyde fixed PVP patches implanted in carotid and femoral arteries and jugular veins
maintained excellentmonth patency and developed functional neo endothelial andsmooth muscle cellsWe
hypothesize that the PVP patch will vascularize in vivo and therefore provide long term patencysince the nonthrombogenic nature of the structure of mesothelium and the biocompatibility of PVP patches to promote vascular
tissue self assemblyTo test this hypothesiswe will validate the safety and efficacy of the PVP patches using
conduit artery and vein in a translational swine modelWe will carry out these studies in aged and hyperlipidemic
swine modelsince vascular repair or reconstruction are frequently needed in the aging patients with
hyperlipidemic complicationsThis proposal addresses a clinically significant problem and successful completion
will provide surgeons with various size options of patches for vascular surgery to ultimately improve patient
outcomesPVP is abundantfrom swinebovineetcand can be fabricated into the desired sizes of vascular
patches NARRATIVE
Although biological and synthetic patches are broadly used in clinical practice for arterial and venous repair or
reconstructionthere remain some shortcomingsThe purpose of this Phase I SBIR is to validate the pulmonary
visceral pleura for arterial and venous patches for vascular repair or reconstruction as a superior biomaterial

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

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