Organogenesis Holdings Inc. confirmed that it completed a Type‑B meeting with the U.S. Food and Drug Administration (FDA) and received permission to begin a rolling Biologics License Application (BLA) for its ReNu therapy, an amniotic suspension allograft designed to treat symptomatic knee osteoarthritis.
ReNu has completed three large Phase 3 randomized controlled trials involving more than 1,300 patients and holds FDA Regenerative Medicine Advanced Therapy (RMAT) designation, received in 2021. While one of the Phase 3 studies did not meet its primary endpoint, the company plans to submit a pooled efficacy analysis that incorporates data from all three trials.
The approval of a BLA could allow ReNu to enter a projected $30 million-plus knee osteoarthritis market, providing a new revenue stream that complements Organogenesis’s existing wound‑care and surgical product lines. The therapy represents a strategic expansion into orthopedics and could broaden the company’s regenerative medicine portfolio.
Chief Operating Officer Patrick Bilbo said the FDA meeting “has confirmed that the ReNu clinical development program, which includes two large Phase 3 trials, a separate 200‑patient trial, and RMAT designation, is appropriate for a BLA submission.” He added that the company believes ReNu will address a significant medical need for a large and growing patient population.
Investors responded positively to the regulatory milestone, reflecting confidence that the BLA submission will reduce uncertainty and position ReNu for a potential launch in 2026 or 2027. The company’s guidance indicates that the BLA will be filed before the end of December 2025, setting the stage for a commercial launch in the following years.
The FDA confirmation removes a major regulatory hurdle and signals that the company’s clinical data and manufacturing processes meet the agency’s standards. If approved, ReNu could become a key growth driver for Organogenesis, diversifying its revenue base and strengthening its position in the regenerative medicine market.
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