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A Novel Polymeric Valve for Transcatheter Aortic Valve Replacement

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2R42HL134418-03A1
Agency Tracking Number: R42HL134418
Amount: $719,175.00
Phase: Phase II
Program: STTR
Solicitation Topic Code: NHLBI
Solicitation Number: PA18-575
Timeline
Solicitation Year: 2018
Award Year: 2020
Award Start Date (Proposal Award Date): 2020-08-01
Award End Date (Contract End Date): 2023-07-31
Small Business Information
25 HEALTH SCIENCES DR
Stony Brook, NY 11790-3350
United States
DUNS: 078714369
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 DANNY BLUESTEIN
 (631) 444-2156
 danny.bluestein@stonybrook.edu
Business Contact
 MARVIN SLEPIAN
Phone: (520) 626-8543
Email: chairman.syns@gmail.com
Research Institution
 STATE UNIVERSITY NEW YORK STONY BROOK
 
W5510 Frank Melville Jr. Memorial Library
STONY BROOK, NY 11794
United States

 Nonprofit college or university
Abstract

Project Summary: A Novel Polymeric Valve for Transcatheter Aortic Valve Replacement
Minimally invasive transcatheter aortic valve replacement (TAVR) has emerged as an effective therapy for the unmet
clinical need of inoperable patients with severe aortic stenosis (AS). Recent longitudinal follow-up studies of TAVR
patients however indicate that this procedure and associated technology may result in serious adverse events. Current
technology is based on tissue valves adapted to, but not specifically designed for TAVR. Those may sustain damage
during crimping as well as deployment, are susceptible to ‘bone-like’ calcific deposition, and suffer from limited
durability. In a collaboration between Stony Brook University and PolyNova Cardiovascular, Inc., we have developed
a novel valve that is specifically designed to tackle the numerous challenges that a TAVR valve will meet during its
life cycle, from crimping to deployment and long term performance in situ. It incorporates (i) novel polymer technology,
xSIBS, which combines superior bio-stability together with excellent mechanical properties, and (ii) a novel design
optimization methodology of the leaflets profile for enhanced hemodynamics, durability, and thromboresistance
performance.
Our broad objective is to develop a viable and durable TAVR valve that will propose a real alternative to existing
bioprosthetic aortic valves, and allow a long-term solution adequate for broader segment of the population. Following
a successful Phase I STTR project, in this Phase II project we aim to expand the Randamp;D activities of our polymeric valve
toward First-In-Man, and implement a robust regulatory and quality management system plans.
The proposed project includes 4 Aims: Aim 1 expand our set of advanced computational flow simulations,
development of a 2nd generation valve, development of a dedicated delivery catheter system, and expanding our valve
product to a complete set of valve sizes. Aim 2 tests the valve performance according to the ISO 5840-3 (transcatheter
heart valves), ISO 25539-1 (cardiovascular implants), and ISO10993-1 (biocompatibility). We will also modify our
valve manufacturing capabilities to be compliant with the FDA quality management system. Aim 3 tests the valves in
vivo in sheep model. The valves are tested for efficacy and safety in acute tests as well as chronic 10 and 20 wks.
Aim 4 is dedicated for integrating regulatory and business plans for PolyNova and for the valve technology.
Integral to this STTR Phase II project is a detailed commercialization and regulatory plan, based on which, and under
the support of this Phase II program, we will convert PolyNova from a pure Randamp;D shop to firm establishment as a
qualified medical device manufacturer– i.e. institution of a fully cGMP, FDA compliant Quality Management System
including a robust Design Control process.
Successful accomplishment of the above aims will lead to a breakthrough in the treatment of aortic valve diseases,
providing an affordable, long-term, minimally invasive solution, enhancing the life of a much broader patient
population.Narrative
The objective of this project is to advance the novel prosthetic transcatheter aortic valve (TAVR) system of
PolyNova Cardiovascular Inc toward clinical use via extensive in vitro and in vivo testing, and by implementing a
robust regulatory and quality management system plans. This valve utilizes novel polymer technology combined
with innovative design optimization methodology, specifically designed to tackle TAVR challenges, with improved
hemodynamics, durability, and crimping performance. In order to translate our novel technology to the market, in
Phase II we will plan to transform PolyNova from a pure Randamp;D startup to a qualified medical device manufacturer that
will lead to a landscape shift by providing a viable long-term TAVR solution for treating severe aortic valve disease.

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

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