Organogenesis Completes Rolling Submission of Biologics License Application for ReNu

Organogenesis Holdings Inc. has completed a rolling Biologics License Application (BLA) submission to the FDA for ReNu®, a cryopreserved amniotic suspension allograft aimed at managing symptomatic knee osteoarthritis (OA). This advancement is a significant milestone in providing new regenerative therapy options for knee OA patients. ReNu has been tested in large clinical trials and previously marketed under a different regulatory framework. The company is optimistic about the regulatory review process and the potential impact of ReNu on treatment options for knee OA, a condition affecting millions of Americans.