Regentis Receives IDE Approval for Pivotal GelrinC Clinical Trial

Regentis Biomaterials received FDA Investigational Device Exemption approval to initiate a pivotal Phase III clinical study of its GelrinC procedure to treat focal knee cartilage defects. The study will support a Premarket Approval Application for U.S. commercialization.

"Gaining IDE approval is a significant step forward for Regentis and...

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Julie Vetalice is ORTHOWORLD's Editorial Assistant. She has covered the orthopedic industry for over 20 years, having joined the company in 1999.

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