Israeli-based CartiHeal Ltd, has been granted “Breakthrough Device Designation” by the FDA for the company’s Agili-C Implant. The designation comes after interim results were announced in December 2019 showing that the predictive probability of success from a pivotal investigational device exemption (IDE) clinical study was greater than 95%.
The study is funded by Johnson & Johnson, Bioventus, Elron, Accelmed, Access Medical Ventures, aMoon and Peregrine Ventures. In January 2020, we wrote that the study is one of the most ambitious and promising cartilage repair studies in history.
Gaining the designation means the agency believes the Agili-C offers “significant” advantages over existing products.
According to the FDA, the designation allows the company to get feedback from FDA staff on device development through “sprint” discussions, data development plans and a clinical protocol agreement. The company also receives prioritized review on future regulatory submissions, including Q-Submissions, Investigational Device Exemption applications and marketing submissions.
In short, the designation is designed “to speed up the development, assessment, and review, while preserving the statutory standards for premarket approval, 510(k) clearance, and De Novo marketing authorization.”
