nanoMesh ™ LLC (A Subsidiary of Exogenesis Corporation) Announces Main Result Achieved in Pathogen Inhibitory Protein (PIP) Uptake Studies nanoMesh ™
BILLERICA, Mass., June 1, 2021 / PRNewswire / – nanoMesh ™ LLC, a subsidiary of Exogenesis Corporation, today announced that it has successfully met the primary endpoint of nanoMesh ™ Pathogen Inhibitory Protein (PIP) uptake studies. PIP trials have demonstrated strong adoption1 a series of proteins that inhibit pathogens2, including casein3,4,5,6 and mucin7 by nanoMesh ™. nanoMesh ™ has a unique surface texture at the nanometer level, thanks to the application of ANAB (Accelerated Neutral Atom Beam) technology8 during manufacture. nanoMesh ™ is indicated for the repair of abdominal wall hernias and abdominal wall deficiencies which require the addition of a reinforcing material to achieve the desired surgical result. nanoMesh ™ is commercially available in the United States9. It has now been shown that nanoMesh ™ solicits the adsorption of proteins known to be inhibitors of the binding of bacteria.
David Earle, MD, FACSten, commented: “These exciting results indicate that the surface-modified ANAB nanoMesh ™ solicits protein uptake by casein and mucin, may control the uptake of critical circulating proteins in humans that inhibit the proliferation of attachment of pathogens forming colonies. This study demonstrates that not only does the nanotextured surface prevent bacterial attachment, it also appears to enhance the 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 in Zoology from Arizona State University in 1986, and his medical degree from University of Arizona in 1990. He completed his training in general surgery at the State University of New York (SUNY) Brooklyn Health Sciences Center in 1995, and a training grant to the Institute of Minimally Invasive Surgery, affiliated with New York Medical College in Westchester County, New York in 1997. He was then hired as head of minimally invasive surgery at SUNY, then recruited at Baystate Medical Center in Springfield, MA in 1998 as director of minimally invasive surgery. During his 17 years at SpringfieldDr. Earle founded and directed a Minimally Invasive Surgical Fellowship, served as Director of the Esophageal Physiology Laboratory, and served on the Board of Trustees of the Baystate Medical Education and Research Foundation. Dr. Earle has been active nationally and internationally in research, device development and clinical care, where approximately 90% of his practice has focused on hernia repair, acting as a reference source for the Northeastern United States. Dr. Earle has held various roles with National Surgical Societies including Chairman of the Guidelines Committee of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) and two terms as a member of the Board of Directors of the Americas Hernia Society. He has long been a fellow of the American College of Surgeons, a diplomat of the American Board of Surgery, and a fellow of the Massachusetts Medical Society. He has participated in hundreds of peer-reviewed scientific and clinical journal articles, scientific meeting presentations, guest lectures, and faculty for surgeon courses around the world. He has written over a dozen book chapters in the field of minimally invasive surgery and hernia repair, and recently published his own manual of natural orifice surgery.
Exogenesis previously announced April 21, 2021, nanoMesh ™ LLC (a subsidiary of ExogenesisCorporation) has completed the first human clinical implantation of nanoMesh ™.
Exogenesis previously reported on April 6, 2021, Completed the US Food and Drug Administration (FDA) Second Pre-Market Notification (510 (k)) filing for nanoMesh ™.
Exogenesis previously reported on January 26, 2021, completion of production validation and sterilization validation as an immediate prelude to the commercialization of nanoMesh ™.
About nanoMesh ™
Exogenesis Hernia Mesh (“nanoMesh ™”) is a proprietary hernia repair product developed and marketed by nanoMesh ™ LLC. Constructed of monofilament polypropylene (PP) and surface treated with ANAB (Accelerated Neutral Atom Beam) technology, nanoMesh ™ is the first hernia repair device on the market with nano-surface modification. nanoMesh ™ is indicated for the repair of herniated defects of the abdominal wall, including inguinal (direct and indirect). nanoMesh ™ is not indicated for the transvaginal repair of pelvic organ prolapse.
About Accelerated Neutral Atomic Beam (“ANAB”) Technology
The Accelerated Neutral Atom Beam (“ANAB”) is a low energy accelerated particle beam that is marketed as a nanoscale surface modification technology. ANAB is created by the acceleration of neutral argon (Ar) atoms with very low energies under vacuum which bombard the surface of a material, altering it to a shallow depth of 2-3nm. It is a non-additive technology that results in changes in surface topography, structure and energy. Medical implants treated with ANAB technology recently received FDA 510 (k) regulatory clearance for use in spinal interbody fusion (IBD) devices.
About Hernia Repair Market
The Global Hernia Repair Market11 should reach $ 5.8 billion by 2026. Hernias often occur in the abdominal wall and are usually visible as an external bulge, especially during exertion or lowering. It affects people to a large extent causing significant pain and discomfort. Age, pregnancy, obesity, muscle fatigue, and surgery increase the risk of hernias. Surgical meshes of various constructions have been used since the end of the 19e century. In recent years, research in the field has increased due to the increasing number of post-surgical 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 thicknesses and porosities, a variety of manufacturing methods, as well as surgical procedures and d implantation. More recently, surface modification methods, as well as the development of nanofiber-based systems, are actively explored as promising avenues to increase the biocompatibility of the available mesh.12
Based at Billerica, Massachusetts, USA, Exogenesis is a private, venture capital-backed company that has developed proprietary technology to modify and control surfaces without coating or creating damage below the surface. Exogenesis markets a platform technology, NanoAccel ™, using ANAB (Accelerated Neutral Atom Beam) and GCIB (Gas Cluster Ion Beam) technologies that modify and control the surfaces of materials on a nanometric scale. The company’s proprietary technologies are used for surface modification and control in a wide range of biomedical, optical and semiconductor applications. For more information, please visit www.exogenesisnanomesh.com or contact us at [email protected]
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1 Data on file at Exogenesis
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
8 Protected by issued and pending patents.
9 Exogenesis Hernia Mesh has received 510 (k) pre-market clearance from the FDA September 26, 2019
ten Dr Earle is Chairman 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 mesh: a review” – Membranes (Basel). 2017 Sep; 7 (3): 47.
SOURCE nanoMesh LLC