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nanoMesh™ LLC (a subsidiary of Exogenesis Corporation) Announces Secondary Endpoint Achieved in nanoMesh™ Pathogen Inhibiting Protein (PIP) Uptake Studies

·6 min read

nanoMesh™, An Innovative Soft Tissue Repair Implant Possesses A Unique Nanometer-level Surface Texture

BILLERICA, Mass., June 9, 2021 /PRNewswire/ -- nanoMesh™ LLC, a subsidiary of Exogenesis Corporation, announced today that it has successfully achieved the secondary endpoints for the nanoMesh™ Pathogen Inhibiting Protein (PIP) uptake studies. The PIP trials demonstrated controlled uptake[1] of a series of pathogen inhibiting, tissue integrating enhancing, and scar formation inhibition proteins[2], including fibronectin[3],[4],[5],[6] and laminin[7] by nanoMesh™. nanoMesh™ possesses a unique nanometer-level surface texture, via the application of Accelerated Neutral Atom Beam (ANAB) technology[8] during manufacturing. nanoMesh™ 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. nanoMesh™ is commercially available in the US[9]. nanoMeshTM has now been shown to solicit the adsorption of proteins known to be inhibitory to the attachment of bacteria.

Karl A. LeBlanc, MD[10] commented, "These exciting results indicate that ANAB surface modified nanoMesh™ can control the uptake of critical circulating proteins in man which has the potential to simultaneously inhibit the attachment and proliferation of colony forming pathogens, accelerate the tissue integration, while inhibiting scar formation. These studies demonstrate exciting differential and positive possibilities for the prevention and/or management of postoperative adverse events associated with hernia mesh implantation.

About Karl Andrew LeBlanc, MD
Karl A. LeBlanc, MD earned his medical degree from LSU Medical School in Shreveport, where he also completed his internship and residency in general surgery. He also received his Master's of Business Administration from LSU. He is Board Certified in general surgery and is a Fellow of the American College of Surgeons (ACS) and the American Society of Metabolic and Bariatric Surgery (ASMBS). He is also a member of the Society for Laparoendoscopic Surgeons (SLS), Society of American Gastrointestinal and Endoscopic Surgeons (SAGES), and is one of the founding members and past presidents of the Americas Hernia Society (AHS). He is a Master Surgeon for Laparoscopic Surgery and has been active in minimally invasive and laparoscopic surgery since its origin. He helped found the Minimally Invasive Surgery Fellowship in Baton Rouge and served as the Fellowship Director from 2004 - 2020. Dr. LeBlanc has authored eight textbooks on minimally invasive, robotic, and hernia surgery and has published numerous articles in peer-reviewed medical literature. Dr. LeBlanc specializes in hernia and abdominal wall reconstruction surgery. He also has special interest in surgery for weight loss, gastroesophageal reflux and foregut disease.

Previous Announcements
Exogenesis previously announced June 1, 2021, Primary Endpoint Achieved in nanoMesh™ Pathogen Inhibiting Protein (PIP) Uptake Studies

Exogenesis previously announced April 21, 2021, nanoMesh™ LLC (a subsidiary of Exogenesis Corporation) Completed First-In-Man Clinical Implantation of nanoMesh™.

Exogenesis previously announced on April 6, 2021, Completion Filing of a Second Pre-Marketing Notification Application (510(k)) with the US Food and Drug Administration (FDA) Regarding nanoMesh™.

Exogenesis previously announced on January 26th, 2021, completion of production validation and sterilization validation as an immediate prelude to commercialization of nanoMesh™.

About nanoMesh™
Exogenesis Hernia Mesh ("nanoMesh™") is a proprietary hernia repair product developed and being commercialized by nanoMesh™ LLC. Constructed of monofilament Polypropylene (PP) and surface treated with Accelerated Neutral Atom Beam (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). nanoMesh™ 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[11] 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.[12]

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, NanoAccel™, 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.exogenesisnanomesh.com or contact us at info@exogenesisnanomesh.com.

[1] Data on file at Exogenesis
[2] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5167704/
[3] Cellular Microbiology (2012) 14(11), 1687–1696
[4]Medical Microbiology and Immunology (2020) 209:277–299
[5]
https://www.sciencedirect.com/science/article/abs/pii/0003996994900590
[6]
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1393211/
[7] The Journal of Infectious Diseases. VOL. 158, NO.4. October 1988
[8] Protected under patents both issued and pending.
[9] Exogenesis Hernia Mesh received FDA 510(k) premarket clearance September 26, 2019
[10] Dr. LeBlanc is a member of the nanoMesh™ Medical Advisory Board
[11] 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
[12] "Past, Present and Future of Surgical Meshes: A Review" - Membranes (Basel). 2017 Sep; 7(3): 47.

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SOURCE nanoMesh LLC