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.
Image: The US FDA’s Center for Devices and Radiological Health. Photo: courtesy of The U.S. Food and Drug Administration.
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).
Accelerated Neutral Atom Beam (“ANAB”) technology is a low-energy accelerated particle beam that is being commercialized as a tool for nano-scale surface modification. ANAB is created by acceleration of neutral argon (Ar) atoms with very low energies under vacuum which bombard a material surface, modifying it to a shallow depth of 2-3 nm. This is a non-additive technology that results in modifications of surface topography, structure, and energy. Medical implants treated with ANAB technology have recently been granted FDA regulatory 510(k) clearance for use in spinal interbody fusion (IBD) devices.
Around 11.2M hernia repair surgeries were performed globally in 2015 and this number is projected to reach approximately 12.6M by 2024.2 The global hernia mesh devices market is expected to grow at a CAGR of 2.0% from 2015 to 2020 to reach a market size of $4B billion by 2020.3
Exogenesis Hernia Mesh is a proprietary hernia repair product developed and being commercialized by Exogenesis. Constructed of monofilament medical grade Polypropylene (PP) and surface treated with Accelerated Neutral Atom Beam (“ANAB”) technology, following FDA premarket clearance, Exogenesis Hernia Mesh will be the first hernia repair implant device in the market with surface nano-modification. Bioactive nano-texture created by ANAB treatment has been shown to improve tissue integration and inhibit pathogen adhesion to the surfaces of implantable medical devices.
Source: Company Press Release