# Advanced manufacturing of a bioprosthetic collagen heart valve

> **NIH NIH R43** · FLUIDFORM, INC. · 2021 · $255,369

## Abstract

Cardiovascular disease is a leading cause of death in the US, Europe and Japan and is comprised of a wide
range of pathologies. One of the most common procedures is heart valve replacement and is required when the
valve fails due to regurgitation or is unable to open fully during the cardiac cycle. Causes include congenital
defects, calcification and prolapse, but regardless of origin there are limited options to repair valves and surgical
treatments are focused primarily on replacement. It is estimated that each year more than 150,000 patients
receive heart valve replacements at a mean cost of ~$200,000 per procedure, corresponding to >$30B cost to
the healthcare system. The heart valve market has continued to grow over the past decade due to advances in
surgical and minimally-invasive technologies associated with heart valve placement. However, current valves
represent some compromise in fit, biological performance, durability and surgical procedure, with unique
advantages and disadvantages associated with current mechanical and bioprosthetic heart valves. In this
proposal our objective is to develop a new bioprosthetic heart valve using advanced manufacturing approaches
that has the durability of mechanical valves, the non-thrombogenicity of biologic valves, the soft deformability for
minimally-invasive transcatheter delivery, and the ability to custom fit the anatomy of any patient. To do this
FluidForm, Inc in collaboration with Carnegie Mellon University will develop a new freeform reversible embedding
of suspended hydrogels (FRESH) 3D printed heart valve using collagen type I that recreates the laminar and
anisotropic extracellular matrix (ECM) architecture in native valves. Our preliminary data shows that FRESH 3D
printing can be used to manufacture functional tri-leaflet heart valves entirely from collagen and can support
physiologic flow rates and pressure for short periods of time. Here we will improve valve performance by
recreating the collagen fiber arrangement and mechanical properties in native valve leaflets via two research
aims. First, we will demonstrate that FRESH 3D printing of collagen type I can recreate the collagen fiber
architecture in the different layers of the native aortic valve leaflets with <10% difference in mean orientation
angle. Second, we will prove that FRESH 3D printed collagen valve leaflets can be engineered to have radial
and circumferential elastic modulus, non-linear stress-strain response, creep, and fatigue life within 75% of native
aortic valve leaflets. Phase I proof-of-concept success will provide a strong foundation for a Phase II SBIR project
that will validate the complete FRESH printed, bioprosthetic aortic valve in an in vitro flow system that simulates
human pressure and flow rate and in a pre-clinical ovine model to assess hemocompatibility and biological
response.

## Key facts

- **NIH application ID:** 10258425
- **Project number:** 1R43HL154956-01A1
- **Recipient organization:** FLUIDFORM, INC.
- **Principal Investigator:** Adam Walter Feinberg
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $255,369
- **Award type:** 1
- **Project period:** 2021-04-01 → 2022-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10258425

## Citation

> US National Institutes of Health, RePORTER application 10258425, Advanced manufacturing of a bioprosthetic collagen heart valve (1R43HL154956-01A1). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10258425. Licensed CC0.

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