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Pulmonary valved conduit xenograft with regeneration potential

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2R44HL147771-02A1
Agency Tracking Number: R44HL147771
Amount: $1,859,567.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: NHLBI
Solicitation Number: PA20-260
Solicitation Year: 2020
Award Year: 2021
Award Start Date (Proposal Award Date): 2021-09-15
Award End Date (Contract End Date): 2023-07-31
Small Business Information
Alpharetta, GA 30022-6137
United States
DUNS: 081242296
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: Yes
Principal Investigator
 (678) 357-3812
Business Contact
Phone: (678) 357-3812
Research Institution

Congenital heart disease affects approximately 40,000 newborns each year in the U.S. Valve and conduit
replacements are needed for absent pulmonary valve, aortic stenosis (Konno procedure, Ross procedure),
double outlet right ventricle (Rastelli operation), extracardiac conduit (Fontan operation), pulmonary valve
replacement (Tetralogy of Fallot). Materials in current use include homograft blood vessels; glutaraldehyde
treated bovine jugular veins (BJV, Contegra), polytetrafluorethylene (PTFE), and woven or knitted Dacron tubes.
The limitations of these materials involve to varying degrees their thrombogenicity, durability, susceptibility to
infection, and lack of growth potential. These materials also have varying degrees of stiffness and flexibility,
which present technical challenges for surgeons, particularly in neonates and infants where size constraints and
limited space in the mediastinum combine with the relatively thin immature native vascular tissues to create
tissue-materials mechanical mismatches, which can compromise the ability to achieve a successful surgical
repair. In Phase I STTR, we tested the feasibility of a prototype from decellularized and pentagalloyl glucose
(PGG) stabilized novel BJV valved conduit device (TxGuard) to augment the already recognized qualities of
BJV. All the preclinical testing shows that TxGuard valved conduit is viscoelastic, biocompatible, resists
calcification, and thrombosis while allowing host cellular infiltration and the potential for remodeling and growth.
To commercialize the TxGuard conduit, we need to obtain data under GMP and GLP conditions that can be
submitted to the FDA for HDE application. Towards this goal, we propose the following specific aims for SBIR
Phase II. Aim 1: Implement quality control SOPs documents for processing of the TxGuard conduit under GMP,
Aim 2: Validate sterilization, packaging, and storage of the TxGuard conduits, Aim 3: Test hydrodynamic
performance and fatigue resistance of TxGuard conduits, Aim 4: Perform long-term preclinical in-vivo testing for
TxGuard conduits. The ovine model of TxGuard pulmonary valved conduit placement (n=6) will be conducted
for 150 days in growing lambs and compared to the clinically available Contegra BJV conduits (n=3) under GLP
conditions for FDA submission. The proposed Phase II SBIR project will spearhead the development of a novel
BJV device (TxGuard) that would repopulate with host cells and slowly regenerate and grow with the patient
without unwanted inflammation and degeneration in contrast to the existing devices.

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

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