Subject: FDA
nanoMeshtm LLC (a subsidiary of Exogenesis Corporation) Announces Completion Filing of a Second Pre-Marketing Notification Application (510(k)) With The US Food and Drug Administration (FDA) nanoMeshtm
BILLERICA, Mass., April 6, 2021 /PRNewswire/ -- nanoMeshtm LLC, a subsidiary of Exogenesis Corporation, announced today that it has successfully completed filing of a second 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. Exogenesis previously announced on January 26th, 2021, completion of production validation and sterilization validation as an immediate prelude to commercialization of nanoMeshtm. The company anticipates first-in-man deployment of nanoMeshtm during the 2nd quarter of 2021, followed immediately thereafter by national distribution. nanoMeshtm is an innovative soft tissue repair implant. nanoMeshtm possesses a unique nanometer-level surface texture, via the application of Accelerated Neutral Atom Beam (ANAB) technology[1] during manufacturing. nanoMeshtm is indicated for the repair of abdominal wall hernias and abdominal wall deficiencies that require the addition of reinforcing material to obtain the desired surgical result. nanoMeshtm is expected to be commercially available throughout the US[2] during 2021.
About nanoMeshtm
Exogenesis Hernia Mesh ("nanoMeshtm") is a proprietary hernia repair product developed and being commercialized by nanoMeshtm LLC. Constructed of monofilament Polypropylene (PP) and surface treated with Accelerated Neutral Atom Beam (ANAB) technology, nanoMeshtm is the first hernia repair device in the market with surface nano-modification. nanoMeshtm is indicated for the repair of abdominal wall hernia defects, including inguinal (direct & indirect). nanoMeshtm is not indicated for transvaginal pelvic organ prolapse repair.
About Accelerated Neutral Atom Beam ("ANAB") Technology
Accelerated Neutral Atom Beam ("ANAB") is a low-energy accelerated particle beam that is being commercialized as a nano-scale surface modification technology. 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.
About the Hernia Repair Market
The global hernia repair market[3] is forecasted to reach $5.8B by 2026. Hernias often occur at the abdominal wall and are generally visible as an external bulge especially during straining or bearing down. It affects people to a large extent, causing significant pain and discomfort. Age, pregnancy, obesity, muscle strain, and surgery increase the risk of hernias. Surgical meshes of various constructions have been in use since the late 19th century. In recent years, research in the area has increased due to increasing numbers of post-surgery complications such as infection, fibrosis, adhesions, mesh rejection, and hernia recurrence. Research has focused on the analysis and implementation of a wide range of materials and coatings, meshes with different fiber thickness and porosity, a variety of manufacturing methods, as well as surgical and implantation procedures. Most recently, surface modification methods, as well as the development of nanofiber-based systems, are actively being explored as promising pathways to increase biocompatibility of available mesh.[4]
About Exogenesis
Headquartered in Billerica, Massachusetts, USA, Exogenesis is a private, venture-capital-backed company that has developed a proprietary technology to modify and control surfaces without applying a coating or creating sub-surface damage. Exogenesis is commercializing a platform technology, NanoAcceltm, utilizing Accelerated Neutral Atom Beam (ANAB) and Gas Cluster Ion Beam (GCIB) technologies that modify and control surfaces of materials at a nanoscale level. The company's proprietary technologies are used for surface modification and control in a broad range of biomedical, optical and semiconductor applications. For more information, please visit www.exogenesis.us or contact us at [email protected].
For more information:
www.exogenesisnanomesh.com
Exogenesis Corp.
20 Fortune Drive
Billerica, MA
USA 01821
Tel: 781-218-9860 Fax: 978-439-0220
[1] Protected under patents both issued and pending.
[2] Exogenesis Hernia Mesh received initial FDA 510(k) premarket clearance September 26, 2019
[3] https://www.globenewswire.com/news-release/2019/05/13/1822683/0/en/Global-Hernia-Mesh-Market-To-Reach-USD-5-78-Billion-By-2026-Reports-And-Data.html
[4] "Past, Present and Future of Surgical Meshes: A Review" - Membranes (Basel). 2017 Sep; 7(3): 47.
SOURCE Exogenesis Corp.
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