Exogenesis Corporation Receives 510(k) Clearance for the Exogenesis Hernia Mesh, First Soft Tissue Repair Device with Nano-Modified Surface
BILLERICA, Mass., Oct. 2, 2019 /PRNewswire/ -- Exogenesis Corporation announced today that it received premarket clearance of a 510(k) application by the US Food and Drug Administration (FDA) for the Exogenesis Hernia Mesh, an innovative implant intended for soft tissue repair. Exogenesis Hernia Mesh possesses a unique nanometer-level surface texture, enabling favorable post implant tissue compatibility via the application of Accelerated Neutral Atom Beam (ANAB) technology(1 )during manufacturing. The Exogenesis Hernia Mesh 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. The Exogenesis Hernia Mesh is expected to be commercially available throughout the US.
The Exogenesis Hernia Mesh is constructed of polypropylene fibers warp knitted together to form the mesh. The knitting process creates a device with large pores and minimum density and thickness similar to the light weight meshes currently on the market. The result is an implant which allows tissue ingrowth that reinforces the tissue defect, while minimizing the inflammatory response and fibrous encapsulation related to implant mass. The mesh possesses the mechanical and physical properties necessary for long term tissue support. The Exogenesis Hernia Mesh is surface treated using a proprietary process to modify the surface of the filaments on a nanometer scale.
"Advances in mesh technology are critical to further improving patient outcomes in hernia repair. I see surface modification at the nanoscale as one of the most important recent technological advances. Exogenesis' FDA clearance is a crucial step in this direction," said David Earle, MD, FACS(2), Director of New England Hernia Center and Associate Professor of Surgery at Tufts University Medical Center.
Dmitry Shashkov, President and CEO of Exogenesis commented, "We are thrilled to receive FDA clearance of the Exogenesis Hernia Mesh premarket application. We are currently completing commercial channel development for this novel product and look forward to bringing it to the clinical community in the near future."
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 construction have been in use since late 19(th) 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 Hernia Mesh
Exogenesis Hernia Mesh is a proprietary hernia repair product developed and being commercialized by Exogenesis. Constructed of monofilament Polypropylene (PP) and surface treated with Accelerated Neutral Atom Beam (ANAB) technology, Exogenesis Hernia Mesh is the first hernia repair device in the market with surface nano-modification. The Exogenesis Hernia Mesh is indicated for the repair of abdominal wall hernia defects, including inguinal (direct & indirect). The Exogenesis Hernia Mesh is not indicated for transvaginal pelvic organ prolapse repair.
About Exogenesis
Exogenesis is commercializing a platform technology, NanoAccel(TM), utilizing Accelerated Neutral Atom Beam (ANAB) and Gas Cluster Ion Beam (GCIB) technologies that modify and control 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.
Exogenesis Corp.
20 Fortune Drive
Billerica, MA 01821
United States
(1) Exogenesis Accelerated Neutral Atom Beam (ANAB) technology is protected internationally by patents, both issued and pending
(2) David Earle, MD, FACS is a Medical Advisor to Exogenesis Corporation
(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.
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SOURCE Exogenesis Corp.
