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

BILLERICA, Mass., June 1, 2021 /PRNewswire/ -- nanoMesh™ LLC, a subsidiary of Exogenesis Corporation, announced today that it has successfully achieved the primary endpoint for the nanoMesh™ Pathogen Inhibiting Protein (PIP) uptake studies. The PIP trials demonstrated strong uptake¹ of a series of pathogen inhibiting proteins², including casein^3,4,5,6 and mucin⁷ by nanoMesh™. nanoMesh™ possesses a unique nanometer-level surface texture, via the application of Accelerated Neutral Atom Beam (ANAB) technology⁸ 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 US⁹. nanoMesh™ has now been shown to solicit the adsorption of proteins known to be inhibitory to the attachment of bacteria.

David Earle, MD, FACS¹⁰, commented, "These exciting results indicate that ANAB surface modified nanoMesh™ solicits protein uptake by casein and mucin, can control the uptake of critical circulating proteins in man which inhibit the attachment proliferation of colony forming pathogens. This study demonstrates that not only does the nano-textured surface prevent bacterial attachment, it also seems to enhance attachment of circulating proteins that are associated with inhibiting bacterial attachment." Dr. Earle continued, "Given the frequency of mesh hernia repair worldwide, the ability of the physical characteristics of nanoMesh™ to prevent mesh infection without antibiotics may have profound clinical implications."

About David Earle, MD, FACS
Dr. Earle, Director, New England Hernia Center - Associate Professor of Surgery at Tufts University School of Medicine, obtained a Bachelor of Science degree in Zoology from Arizona State University in 1986, and his MD degree from the University of Arizona in 1990. He completed his general surgical training at The State University of New York (SUNY) Health Science Center at Brooklyn in 1995, and fellowship training at the Institute of Minimally Invasive Surgery, affiliated with New York Medical College in Westchester County, New York in 1997. He was then hired as the Chief of Minimally Invasive Surgery at SUNY, and subsequently recruited to Baystate Medical Center in Springfield, MA in 1998 as the Director of Minimally Invasive Surgery. During his 17 years in Springfield, Dr. Earle founded and directed a Minimally Invasive Surgical Fellowship, was Director of the Esophageal Physiology Laboratory, and served on the board of the Baystate Medical Education and Research Foundation. Dr. Earle has been nationally and internationally active in research, device development, and clinical care, where approximately 90% of his practice was focused on hernia repair, acting as a referral source for the Northeastern United States. Dr. Earle has been involved in a variety of roles in national surgical societies, including Chairman of the Guidelines Committee of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) and two terms as a Board Member of the Americas Hernia Society. He has been a longstanding Fellow of the American College of Surgeons, Diplomat of the American Board of Surgery, and member of the Massachusetts Medical Society. He has been involved in hundreds of peer-reviewed scientific and clinical journal articles, scientific meeting presentations, invited lectures, and faculty for surgeon courses around the globe. He has written over a dozen book chapters in the field of minimally invasive surgery and hernia repair, and recently published his own textbook of Natural Orifice Surgery.

Previous Announcements
Exogenesis previously announced April 21, 2021, nanoMesh™ LLC (a subsidiary of ExogenesisCorporation) 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 market¹¹ 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 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.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 [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 Data on file at Exogenesis
² https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5167704/
³ https://doi.org/10.1016/j.fshw.2019.03.010
⁴ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7074799/#:~:text=Moreover%2C%20%CE%BA%2Dcasein%20may%20decrease,reducing%20its%20activity%20%5B15%5D
⁵ https://www.sciencedirect.com/science/article/abs/pii/0003996994900590
⁶ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1393211/
⁷ https://dx.doi.org/10.1159%2F000163037
⁸ Protected under patents both issued and pending.
⁹ Exogenesis Hernia Mesh received FDA 510(k) premarket clearance September 26, 2019
¹⁰ Dr. Earle is Chair 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.

SOURCE nanoMesh LLC