Organogenesis is committed to the highest standards of ethical conduct and regulatory compliance and is committed to conducting its business affairs and interactions with customers, patients, and health care practitioners in a manner that is compliant with all applicable laws, regulations, and industry guidelines.
The regulatory documents provided below are those that are commonly requested for administrative purposes. These documents are updated on a routine basis. For additional documents or information, please contact the Medical Information Center at 1-888-HEAL-2DAY (888-432-5232), option 6.
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, has been granted Regenerative Medicine Advanced Therapy (RMAT) designation by the U.S. Food and Drug Administration (FDA) for ReNu®, a cryopreserved amniotic suspension allograft (ASA) for the management of symptoms associated with knee osteoarthritis (KOA).
As a result of the RMAT designation, Organogenesis is making this public disclosure of its Expanded Access Policy (EAP) in accordance with section 561A of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
At this time, Organogenesis is not currently making its IND-related product available on an expanded access basis. You may reference information about our IND clinical trial by accessing: https://clinicaltrials.gov/ct2/show/NCT04636229?term=Amniotic&cond=Osteoarthritis%2C+Knee&draw=2&rank=5%23contacts.
In the event Organogenesis decides to consider expanded access, we will evaluate and respond to each request that we receive from a patient's treating physician on a case-by-case basis. If you have questions about Organogenesis' expanded access policy, please contact Organogenesis at firstname.lastname@example.org.
In accordance with the 21st Century Cures Act, Organogenesis may revise this policy at any time.
Regulatory Documentation Per Manufacturing Site
Links to FDA Documents:
Links to Tissue Bank Licenses: