Biocompatibility testing of the COSMIIC System

NIH RePORTER · NIH · U41 · $73,908 · view on reporter.nih.gov ↗

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
CASE WESTERN RESERVE UNIVERSITY
Principal Investigator
Cynthia Anne Chestek
Activity code
U41
Funding institute
NIH
Fiscal year
2024
Award amount
$73,908
Award type
3
Project period
2024-05-01 → 2025-08-31