# Performance Evaluation of a non-Degradable Synthetic Device for Chondral and Osteochondral Defects of the Knee

> **NIH NIH R44** · HYDRO-GEN, LLC · 2020 · $300,820

## Abstract

Injury to joints can lead to painful defects in articular cartilage and the underlying bone, which adversely affect
the function and biological health of the entire joint. Current solutions for cartilage (chondral) and cartilage-and-
bone (osteochondral) defects, are unreliable, are technically challenging, and often require multiple procedures.
A surgeon-engineer-biologist team at Hospital for Special Surgery (HSS) dedicated >10 years of research to the
design and functional evaluation of a solution to this problem which led to the formation of the first spin-out
company from HSS in its 156-year history. AGelity-OCI (OsteoChondral Implant), is a non-cell based, non-
degradable synthetic device, consisting of two layers: a poly(vinyl alcohol) hydrogel, PVA, integrated into a
porous Titanium base. The PVA layer is designed with a solid core to withstand physiological loads and a patent
protected concentric porous sponge that hydrates in situ to produce a snug press-fit against the host articular
cartilage, leading to lateral integration. Using in vitro, in silico, and in vivo models we have demonstrated that
AGelity-OCI integrates with bone and articular cartilage without causing joint synovitis, inflammation, or damage
to the opposing surfaces of the joint, the interface between PVA and porous titanium (which was optimized using
Phase I SBIR funds) maintains mechanical integrity, and the device distributes loads similar to the native tissue.
The objective of this study is to fully characterize the mechanical, structural, chemical, morphological, biological,
and functional characteristics of AGelity-OCI as per regulatory guidelines. Our over-arching hypothesis is that
AGelity-OCI is a safe and effective device for the treatment of focal chondral and osteochondral defects. This
hypothesis will be tested using two Specific Aims. Specific Aim 1: To characterize the chemical, morphological,
and materials performance of our as-manufactured post-sterilized device and its components. Our hypothesis is
that the device will meet federal guidelines for safety. Specific Aim 2: To characterize the biological and
functional in vivo behavior of AGelity-OCI. Our hypothesis is that AGelity-OCI will be non-inferior to fresh frozen
osteochondral allografts. Our efforts to commercialize this device are at a mature translational de-risked stage:
(i) a Pre-IDE meeting with the FDA in February 2018 was completed; the minutes from which frame the details
of the current proposal (ii) intellectual property is protected by five patents, (iii) AGelity-OCI is currently
manufactured, packaged and sterilized by an FDA registered and ISO certified manufacturing facility, and (iv)
the core investigative team spans engineering, surgery, manufacture, pre-clinical testing, regulatory and
business strategy. Our device-based approach represents a significant shift in the current paradigm for the
treatment of osteochondral defects by avoiding the highly variable results from cell-base...

## Key facts

- **NIH application ID:** 10020170
- **Project number:** 5R44AR067533-03
- **Recipient organization:** HYDRO-GEN, LLC
- **Principal Investigator:** TONY CHEN
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $300,820
- **Award type:** 5
- **Project period:** 2015-09-01 → 2023-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10020170

## Citation

> US National Institutes of Health, RePORTER application 10020170, Performance Evaluation of a non-Degradable Synthetic Device for Chondral and Osteochondral Defects of the Knee (5R44AR067533-03). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10020170. Licensed CC0.

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