# Immune-compatible, unfixed, xenogeneic extracellular matrix for heart valve prostheses

> **NIH NIH R44** · VIVITA TECHNOLOGIES, INC. · 2022 · $751,276

## Abstract

ABSTRACT
In this Phase II SBIR application, ViVita Technologies, Inc. (Davis, CA) aims to validate its patented technology
(SPEAR Platform – US 9,220,733) towards development of unfixed, immune-compatible, and regenerative
xenogeneic biomaterials for heart valve replacements. In the U.S., 100,000 heart valve replacement procedures
are performed annually, representing a $1.7 billion annual burden. Although current bioprostheses
(glutaraldehyde-fixed bovine pericardium or porcine aortic valves) are superior to mechanical alternatives, the
fixation process only permits longevity of ~10 years in adults due to chronic immune rejection and resultant
mechanical failure of the biomaterial. Further, this fixation process renders the biomaterial incompatible with
recipient cellular repopulation, regeneration, and repair. These deficiencies led the National Heart, Lung, and
Blood Institute: Cardiac Surgery Working Group to recommend future support of basic biomaterial research for
heart valve prostheses. To avoid aggressive rejection of unfixed animal tissues, decellularization protocols focus
on reducing immunologic burden via removal of cellular components; however, persistence of both cellular and
non-cellular immunogenic components following decellularization elicits in vivo immune responses. By targeting
removal of immunological barriers themselves, the SPEAR Platform produces unfixed biomaterials (BARE patch
– US 9,827,350) that avoid the rapid immune destruction experienced by transplanted animal tissues, while
maintaining the native extracellular matrix (ECM) structure-function relationships critical for implant longevity and
function. Indeed, BARE patch (1) elicits minimal graft-specific adaptive immune response, thereby avoiding
associated calcification, (2) appears as “self” to the innate immune system, facilitating integration with recipient
tissue, and (3) promotes rapid non-immune cellular repopulation and resultant regeneration. This proposal will
provide several insights into commercialization of BARE patches for next-generation heart valve replacements.
Uniformity of antigen removal from clinical-sized BARE patches will be quantified throughout different regions of
large patches (Aim 1). Sterilization capacity of SPEAR Platform will be quantified by microorganism challenge
testing to inform the need for terminal sterilization (Aim 2). Rate of residuals elimination will be quantified to
inform the necessary manufacturing wash procedures (Aim 3). Structure-function-durability properties of BARE
patch will be quantified at a range of storage temperatures and times to inform product shelf life (Aim 4). Finally,
a valved conduit fabricated from BARE patch will be assessed in pivotal FDA IDE enabling studies for in vivo
hemodynamic performance and regenerative capacity over 6 months in an ovine aortic model (Aim 5). Like our
successful Phase I effort, all Aims will be performed in collaboration with one of our strategic partners, a leading
heart ...

## Key facts

- **NIH application ID:** 10478303
- **Project number:** 1R44HL164140-01
- **Recipient organization:** VIVITA TECHNOLOGIES, INC.
- **Principal Investigator:** Maelene L Wong
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $751,276
- **Award type:** 1
- **Project period:** 2022-05-23 → 2024-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10478303

## Citation

> US National Institutes of Health, RePORTER application 10478303, Immune-compatible, unfixed, xenogeneic extracellular matrix for heart valve prostheses (1R44HL164140-01). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10478303. Licensed CC0.

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