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# Organogenesis Advances ReNu Toward FDA Filing After Key Meeting
- URL: https://www.fdaweb.com/organogenesis-advances-renu-toward-fda-filing-after-key-meeting/
- Published: 2026-04-07T12:00:00.000Z
- Updated: 2026-09-14T13:36:57.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5160945

Organogenesis says it has reached a key regulatory milestone for its knee osteoarthritis treatment ReNu, following a Type B meeting with FDA that has cleared the way for a rolling BLA submission later this year. ReNu, a cryopreserved amniotic suspension allograft, is being developed to treat symptomatic knee osteoarthritis, a widespread degenerative joint condition. The therapy combines amniotic fluid-derived cells and micronized membrane tissue, delivering growth factors and extracellular matrix components intended to support joint function, according to the company.

According to the company, the planned BLA will be supported by two large Phase 3 randomized controlled trials, as well as data from more than 1,300 patients studied across three trials. ReNu also received Regenerative Medicine Advanced Therapy designation from FDA in 2021, a status intended to expedite the development of regenerative therapies addressing serious conditions.