# Biocompatibility testing of the COSMIIC System

> **NIH NIH U41** · CASE WESTERN RESERVE UNIVERSITY · 2024 · $73,908

## Abstract

Abstract Summary
Biocompatibility testing of the COSMIIC System
The aim of this supplement is to conduct biocompatibility testing of the COSMIIC System
components, under currently accepted standards (ISO 10993-1), and to make the testing
procedures and results available to the public under our open source licenses. The Specific Aims
of this supplement are:
Specific Aim #1 Complete a Q-Sub with the FDA to gain insights into biocompatibility
requirements for a device covered in an Early Feasibility Study (EFS) Investigational Device
Exemption (IDE).
Specific Aim #2 Generate a comprehensive Biological Evaluation Report (BER).
Specific Aim #3 Develop a toxicology risk assessment based on chemical characterization and
test results.
Specific Aim #4 Publish all test procedures (to the extent allowable) and all test results freely
available under the COSMIIC open source licenses.

## Key facts

- **NIH application ID:** 10998507
- **Project number:** 3U41NS129436-02S6
- **Recipient organization:** CASE WESTERN RESERVE UNIVERSITY
- **Principal Investigator:** Cynthia Anne Chestek
- **Activity code:** U41 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $73,908
- **Award type:** 3
- **Project period:** 2024-05-01 → 2025-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10998507

## Citation

> US National Institutes of Health, RePORTER application 10998507, Biocompatibility testing of the COSMIIC System (3U41NS129436-02S6). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10998507. Licensed CC0.

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