nanoMesh files second PMA (510(k)) with FDA for Exogenesis Hernia Mesh
nanoMesh, a subsidiary of Exogenesis, has successfully completed filing of a second Pre-Marketing Notification Application (510(k)) with the FDA for its first proprietary soft tissue repair device, Exogenesis Hernia Mesh. nanoMesh is an innovative soft tissue repair implant and, according to the company, possesses a unique nanometer-level surface texture, via the application of Accelerated Neutral Atom Beam (ANAB) technology during manufacturing.
Constructed of monofilament Polypropylene (PP) and surface treated with ANAB technology, nanoMesh is the first hernia repair device in the market with surface nano-modification. nanoMesh is indicated for the repair of abdominal wall hernia defects, including inguinal (direct & indirect) that require the addition of reinforcing material to obtain the desired surgical result. nanoMesh is not indicated for transvaginal pelvic organ prolapse repair.
Exogenesis expects feedback from the FDA during the next quarter and anticipates entering the US market with Exogenesis Hernia Mesh following FDA premarket clearance. The company anticipates first-in-man deployment of nanoMesh during the 2nd quarter of 2021, followed immediately thereafter by US distribution.