Organogenesis Holdings Inc. (ORGO) ,a regenerative medicine company announced that it has initiated the submission of a Biologics License Application or BLA to the US Food and Drug Administration or FDA for its lead amniotic suspension allograft, ReNu, for the management of symptomatic knee arthritis.
The Organogenesis BLA submission, including the final modules, is expected to be completed in the first half of 2026.
The initiation of the BLA was driven by ReNu's three large randomised controlled trials, which enrolled more than 1,300 patients and FDA Regenerative Medicine Advanced Therapy or RMAT designation for Knee osteoarthritis received in 2021. Before BLA, ReNu was previously marketed under Section 361 of the Public Health Service Act and was commercially available for approximately six years.
Patrick Bilbo, Chief Operating Officer of Organogenesis, said that if approved, ReNu would be the first non-surgical biologic therapy to address knee osteoarthritis pain for all patients, especially for those classified as most severe.
Knee osteoarthritis is a common degenerative joint disease impacting an estimated 31.1 million Americans today, with cases expected to rise to 34.4 million by 2027. When all other treatments have been exhausted, a total knee replacement is the only end-stage management option.
ReNu is a cryopreserved, amniotic suspension allograft developed for the management of symptomatic knee osteoarthritis. ReNu consists of amniotic fluid cells and micronized amniotic membrane and contains cellular, growth factor, and extracellular matrix components.
For the most recent third quarter of 2025, Organogenesis reported an increased net income of $21.6 million compared to $12.3 million in the year-ago quarter. Also, Net product revenue for the third quarter increased to $150.5 million from $115.2 million in the prior year.
Over the past year, ORGO have traded in the range of $2.61 and $7.08.
On Tuesday, ORGO closed trading 0.70 % higher at $5.75.
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