Organogenesis Nears Key Data Milestone With Phase 3 Knee Osteoarthritis Study

Organogenesis Holdings (ORGO) announced an update on their ongoing clinical study.

Study Overview

Organogenesis Holdings (ORGO) is sponsoring a phase 3 trial titled “A Phase 3 Prospective, Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy of Amniotic Suspension Allograft (ASA) in Patients With Osteoarthritis of the Knee.” The study aims to see if ASA can safely reduce knee pain and improve function in people with knee osteoarthritis compared with placebo. This matters because knee osteoarthritis is common, often painful, and current options are limited, so any new non-surgical treatment with solid late-stage data could be commercially important.

Intervention/Treatment

The main treatment tested is Amniotic Suspension Allograft, a biological product made from human amnion tissue and cells from amniotic fluid. It is given as a single injection into the knee joint. The goal is to ease symptoms of knee osteoarthritis and potentially delay the need for more invasive treatments. The control group receives a saline injection that acts as a placebo for comparison.

Study Design

This is an interventional phase 3 study with patients randomly assigned to either ASA or placebo in a 1:1 ratio. Both groups receive a single knee injection, and neither the patients nor the medical staff know who got which treatment (quadruple blinding). The model is “parallel,” meaning participants stay in their assigned group throughout. The main purpose is treatment, not diagnosis or prevention, and the focus is on how well ASA works and how safe it is compared with placebo in real-world clinical settings.

Study Timeline

The study was first submitted to the registry on August 14, 2023, marking its formal start in the public record and signaling that patient enrollment and trial operations were underway. The trial has now reached “Completed” status, indicating that patient treatment and follow-up for primary outcomes are finished, though detailed results have not yet been posted. The last update was submitted on December 22, 2025, which confirms that the trial record is current and the sponsor has recently reviewed and refreshed key information. No results are publicly available yet, so investors should view this as a late-stage program at an important data inflection point.

Market Implications

For ORGO, completion of this phase 3 knee osteoarthritis study is a meaningful milestone. A positive readout could support regulatory filings, expand the company’s advanced wound care and regenerative medicine portfolio into a large pain and mobility market, and strengthen the investment case for revenue growth beyond its core business. Conversely, weak or negative results would likely pressure the stock, as expectations for a differentiated knee osteoarthritis asset would reset. The broader musculoskeletal and orthobiologics space includes competitors working on hyaluronic acid injections, platelet-rich plasma, and other amniotic products, so strong, well-controlled phase 3 data could help ORGO stand out in a crowded field. Investor sentiment will hinge on the magnitude and durability of pain and function benefits versus placebo, as well as any safety signals.

The study is completed and recently updated, and investors can track future data releases and detailed information on the ClinicalTrials portal.

To learn more about ORGO’s potential, visit the Organogenesis Holdings drug pipeline page.