Aziyo receives a Not Substantially Equivalent from FDA for CanGaroo RM

Aziyo Biologics provides an update on its submission to the U.S. Food and Drug Administration, FDA, for the CanGaroo RM Antibacterial Envelope, the Company’s next-generation biomaterial envelope. The device is intended to securely hold a cardiac implantable electronic device or neurostimulator, creating a stable environment when implanted in the body. As previously announced, the Company submitted a 510(k) premarket notification for the CanGaroo RM Antibacterial Envelope to the FDA in April 2022. As a combination product containing device and drug components, the filing was reviewed by the Center for Devices and Radiological Health and the Center for Drug Evaluation and Research. On March 16, 2023, the Company received a Not Substantially Equivalent determination from FDA. The notice defined the outstanding items that need to be addressed in order to obtain market clearance. The items relate to drug testing, primarily a request by FDA to modify an in vitro drug release assay employed as a manufacturing control. As a result, the Company does not expect to appeal the decision, as it believes the most expeditious path forward is to work with FDA to provide the additional data requested. "While we are disappointed with the delay, we are gratified that the completed review did not raise any questions surrounding the appropriateness of the pathway or majority of the data submitted to support the filing," said Dr. Randy Mills, President and Chief Executive Officer of Aziyo Biologics. "We have our marching orders and are confident that we can address the FDA’s questions promptly."