Exogenesis Corporation announced today that it has successfully completed filing of a Pre-Marketing Notification Application (510(k)) with the US Food and Drug Administration (FDA) for its first proprietary soft tissue repair device, Exogenesis Hernia Mesh. Exogenesis expects feedback from the FDA during the next quarter and anticipates entering the US market with Exogenesis Hernia Mesh following FDA premarket clearance.
Dmitry Shashkov, President and CEO of Exogenesis commented, “We are excited to reach this important milestone in our product development. Our Accelerated Neutral Atom Beam1 (“ANAB”) surface treatment technology is already being deployed on other FDA-cleared devices, however Exogenesis Hernia Mesh is our first proprietary product developed entirely in-house. ANAB has the bioactive potential to improve medical device implant responses in man and we are excited to bring this exciting technology one step closer to the clinical community.”
Exogenesis will highlight the Exogenesis Hernia Mesh and other developments of its ANAB enhanced medical device technology during two upcoming international conferences: The International Symposium on Surfaces and Interfaces for Biomaterials (ISSIB, Quebec City, Canada, July 22-25 2019) and American Vacuum Society International Symposium and Exhibition (AVS-66, Columbus, Ohio, October 20-25 2019).