Development Pipeline
OrthoPreserve is advancing through a rigorous pre-clinical development program on a clear path toward first-in-human clinical trials. Our regulatory strategy has been validated through two milestone FDA designations, and we are fundraising to complete the final testing required for Investigational Device Exemption (IDE) submission to initiate clinical trials.
| 2021 |
Company Founded ✓
OrthoPreserve founded by orthopedic clinicians and biomedical engineers to commercialize the meniscus implant technology developed at a leading U.S. academic institution from 2016 to 2020.
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| 2023 |
NIH SBIR Grant Awarded ✓
Funded animal studies, long-term durability simulation testing, and refinement of minimally invasive surgical technique.
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| 2024 |
FDA Breakthrough Device Designation ✓
Granted December 2024 - confirms significant clinical need and streamlines the FDA review pathway.
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| 2025 |
FDA TAP Program Acceptance ✓
First orthopedic device accepted into the FDA Total Product Lifecycle Advisory Program (TAP), enabling direct collaboration with FDA and other stakeholders.
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| 2026–27 |
IDE Submission & Clinical Trial Initiation
Current seed round will fund remaining pre-clinical testing required for IDE submission and first-in-human clinical trials, targeted for 2027.
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