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Devices Surgery FDA

 News Release - July 24, 2019

Exogenesis Corporation Announces the Filing of a 510(k) Pre-Marketing Notification Application with the US Food and Drug Administration for Exogenesis Hernia Mesh

Exogenesis Hernia Mesh is the First Soft Tissue Repair Device with Nano-Modified Surface

BILLERICA, Mass., July 24, 2019 -- (Healthcare Sales & Marketing Network) -- 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).

About Accelerated Neutral Atom Beam ("ANAB") Technology

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.

About the Hernia Repair Market

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

About Exogenesis Hernia Mesh

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.

About Exogenesis

Exogenesis is commercializing a platform technology, NanoAccel™, utilizing Accelerated Neutral Atom Beam (ANAB) and Gas Cluster Ion Beam (GCIB) technologies that modify and controls surfaces of materials at a nanoscale level. 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. 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 info@exogenesis.us.

1 ANAB Technology is protected by US and International Patents, both Issued and Pending

2 http://databridgemarketresearch.com/reports/global-hernia-mesh-repair-devices-market/

3 http://www.prnewswire.com/news-releases/hernia-mesh-devices-market-by-hernia-type-product-type-and-geography---global-forecast-to-2020-300280520.html


Source: Exogenesis

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