# SBIR Phase I: Novel Hyaluronan Enhanced Polymeric Trans-Catheter Aortic Valve

> **NIH NIH R43** · YOUNGHEARTVALVE LLC · 2021 · $442,419

## Abstract

Project Summary:
Our long-term goal is to commercialize hyaluronan enhanced polymeric transcatheter aortic valves (HAPTAVs)
that have the durability of surgically implanted mechanical valves, do not require life-long anticoagulation, avoid
the emerging problems for tissue-based TAVs, and are made from low-cost, synthetic materials using automated
manufacturing. A novel biomaterial, made of engineering plastic (polyethylene) that, at a molecular level, is
interlocked with a naturally occurring biomolecule (hyaluronan or HA) is used to make highly hydrophilic,
blood-friendly polymer leaflets with the durability of engineered synthetic polymers. In both the laboratory and in
live sheep, these valves have shown excellent hemodynamic performance and durability without any thrombus
formation or calcification. With this Phase I application we aim to demonstrate that the long-term durability,
hemodynamics, and performance of the HAPTAVs meet or exceed international standards, and take the initial
steps toward developing a commercialization strategy to position the business for Phase II SBIR and Series A
funding. We will use our current Phase I Design prototype HAPTAVs in both Aims 1 and 2. Aim 1 will have
independent entities test the long-term fatigue and hemodynamic performance according to international (ISO)
standards. Aim 2 will work with a standard industry contract research organization (NAMSA) to prepare an FDA
pre-submission and regulatory strategy, and facilitate a meeting with the FDA. We will work with Larta Inc. to
develop our commercialization strategy for a Phase II submission. YoungHeartValve, LLC was co-founded in
early 2020 by Dr. Dasi (Chief Technology Officer), an expert in heart valve engineering and cardiovascular
biomechanics, and Dr. James (Chief Operating Officer), who is an established polymer materials scientist, and
the inventor of HA-polyethylene materials. Mr. Todd Tomba, joined YoungHeartValve mid 2020 as CEO and
President. He brings over three decades of medical device industry, and specifically heart valve replacement
commercialization experience, to the team.

## Key facts

- **NIH application ID:** 10325141
- **Project number:** 1R43HL158387-01A1
- **Recipient organization:** YOUNGHEARTVALVE LLC
- **Principal Investigator:** Todd Charles Tomba
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $442,419
- **Award type:** 1
- **Project period:** 2021-08-01 → 2023-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10325141

## Citation

> US National Institutes of Health, RePORTER application 10325141, SBIR Phase I: Novel Hyaluronan Enhanced Polymeric Trans-Catheter Aortic Valve (1R43HL158387-01A1). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10325141. Licensed CC0.

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