Organogenesis Enrolls First Patient in Pivotal Phase 3 Clinical Trial of RMAT-Designated ReNu® for Knee Osteoarthritis
“We are very pleased to have initiated our ReNu pivotal Phase 3 trial,” said
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
OA is a degenerative joint disease that affects more than 30 million Americans and accounts for more than
ReNu® is a cryopreserved, amniotic suspension allograft (ASA) for the treatment of symptomatic knee osteoarthritis. ReNu consists of amniotic fluid cells and micronized amniotic membrane and contains cellular, growth factor, and extracellular matrix components.
Learn more at https://organogenesis.com/surgical-sports-medicine/renu/
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements about the potential benefits of an RMAT designation. These forward-looking statements relate to expectations or forecasts for future events. Forward-looking statements may be identified by the use of words such as “will,” “forecast,” “intend,” “seek,” “target,” “anticipate,” “believe,” “expect,” “estimate,” “plan,” “outlook,” “extend,” “continue” and “project” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. Forward-looking statements are based on current expectations that are subject to known and unknown risks and uncertainties, which could cause actual results or outcomes to differ materially from expectations expressed or implied by such forward-looking statements. These factors include risks related to the Company’s ability to maintain and benefit from RMAT designation, which may not result in a faster development process or review of the Company’s product candidates (and which may later be rescinded by the FDA), and does not assure approval of such product candidates by the FDA or the ability of the Company to obtain FDA approval in time to benefit from commercial opportunities, in addition to risks and uncertainties described in the Company’s filings with the
Press and Media Inquiries:
Lori Freedmanlfreedman@organo.com Investor Inquiries: Westwicke Partners Mike Piccinino, CFA OrganoIR@westwicke.com 443-213-0500
Source: Organogenesis Holdings Inc.