ORGO - Organogenesis' reports positive interim analysis of Phase 3 ReNu trial for knee pain

Organogenesis Holdings ( NASDAQ: ORGO ) has reported favorable outcome of the interim analysis of its Phase 3 trial of ReNu, a cryopreserved amniotic suspension allograft (ASA) for management of symptoms associated with knee osteoarthritis.

The pre-specified interim analysis on 50% of the 474 required patients focused on the 6-month primary endpoint of the trail is the reduction in knee pain assessed by the Western Ontario and McMaster Universities Arthritis Index pain scale performed on subjects treated with ReNu or saline for potential sample size re-estimation.

The Independent Data Monitoring Committee (DMC) recommended that the trial proceed without modification and without increase to sample size.

Additionally, the DMC found the safety data to be consistent with the known safety profile for ReNu.

Yesterday, the company also reported Q4 results and expects FY2023 net revenue between $450M and $462M .

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