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 pre-clinical testing required for Investigational Device Exemption (IDE) submission to initial clinical trials.
| 2021 |
Company Founded ✓
OrthoPreserve founded by orthopedic clinicians and biomedical engineers to commercialize the meniscus implant technology out of a leading U.S. institution (2016-2020).
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| 2023 |
NIH SBIR Grant Awarded ✓
Funded animal studies 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, 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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