Organogenesis Holdings Inc. (Nasdaq: ORGO), a leading regenerative medicine company focused on the development, manufacture and commercialization of product solutions for the Advanced Wound Care and Surgical & Sports Medicine markets, today announced that the first patient has been enrolled in its pivotal Phase 3 clinical trial evaluating the safety and efficacy of ReNu®, a cryopreserved amniotic suspension allograft (ASA), for the management of symptoms associated with knee osteoarthritis (OA).
“We are very pleased to have initiated our ReNu pivotal Phase 3 trial,” said Patrick Bilbo, Chief Operating Officer for Organogenesis. “This significant milestone comes on the heels of the FDA’s RMAT designation underscoring the strength of our existing ReNu clinical evidence and its potential to address a largely unmet medical need. We look forward to leveraging our RMAT designation to work closely with the FDA to expedite the review of ReNu as the study progresses.”
The Phase 3 study is a prospective, double-blind, multicenter, placebo-controlled, parallel group, randomized control trial (RCT) of ReNu in 474 subjects with moderate to severe symptomatic knee osteoarthritis. Patients will be randomized to either a single intra-articular (IA) injection of saline (placebo control) or a single injection of ReNu. The primary efficacy endpoint is the difference in pain from baseline to 6 months as assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
OA is a degenerative joint disease that affects more than 30 million Americans and accounts for more than $185 billion in annual expenditures. Knee OA has been estimated to affect approximately 14 million Americans ages 25 and older, with nearly 8 million under the age of 65. The number of knee replacement surgeries is growing every year, and expected to rise from approximately 680,000 Americans in 2014 to 1.28 million Americans in 2030.
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.