nanoMesh™ LLC (a subsidiary of Exogenesis Corporation) Announces nanoMesh™ Implant In-Vivo Inflammation Results

BILLERICA, Mass., Nov. 10, 2021 /PRNewswire/ -- nanoMesh™ LLC, a subsidiary of Exogenesis Corporation, announced today initial nanoMesh™ post-implant inflammation results. Inflammation post-implant of surgical mesh has been associated with scar formation and patient discomfort¹. Exogenesis previously reported² Pathogen Inhibiting Protein (PIP) uptake studies demonstrating controlled uptake³ of a series of pathogen inhibiting, tissue integrating enhancing, and scar formation inhibition proteins⁴, including fibronectin^5,6,7,8 and laminin⁹ by nanoMesh™. nanoMesh™ possesses a unique nanometer-level surface texture, via the application of Accelerated Neutral Atom Beam (ANAB) technology¹⁰ 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 US¹¹. nanoMesh™ has now been shown to solicit the adsorption of proteins known to be inhibitory to the attachment of bacteria.

John Keating, DVM, DACVP - Director, Pathology, CBSET (Lexington, MA) reviewing the results of this study, conducted at CBSET commented, "nanoMesh™ was associated with lower inflammation compared to the control implant mesh during evaluations 14- and 28-days post implant."  Dr. Keating continued, "These results could suggest a lower inflammatory tissue reaction to nanoMesh™ than standard meshes."

About John Keating, DVM, DACVP - Director, Pathology
John Keating, Director of Pathology at CBSET, has an extensive background in gross and histologic pathology of mammalian and non-mammalian, domestic and non-domestic species.  After multiple years in academia, with extensive collaboration and publications with colleagues in clinical veterinary medicine and basic sciences, he joined CBSET in 2010 to focus on non-clinical studies with an emphasis on evaluating tissue responses in the development of novel therapies including drugs, biologics, and biomedical devices.

About CBSET
CBSET is a state-of-the-art biomedical research institute located in Lexington MA. CBSETs mission is to advance biomedical research through innovative, high-quality services. CBSET combines top-tier research with operational expertise. Since its inception, CBSET has continued to develop technical and scientific acumen through collaborative projects in the medical device, pharmaceutical and academic communities. CBSETs GLP-compliant, and AAALAC-accredited facility includes vivaria, procedure rooms, catheterization / imaging labs, surgical and necropsy suites, histopathology, SEM, and a range of other technologies.

Previous Announcements
Exogenesis previously announced August 17, 2021 Formation of a Medical Advisory Board

Exogenesis previously announced  June 9, 2021, Secondary Endpoint Achieved in nanoMesh™ Pathogen Inhibiting Protein (PIP) Uptake Studies,

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 market¹² 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.¹³

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].

¹ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5896652/
² "nanoMesh™ LLC (a subsidiary of Exogenesis Corporation) Announces Secondary Endpoint Achieved in nanoMesh™ Pathogen Inhibiting Protein (PIP) Uptake Studies", PRNEwswire June 9, 2021
³ Data on file at Exogenesis
⁴ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5167704/
⁵ Cellular Microbiology (2012) 14(11), 1687–1696
⁶ Medical Microbiology and Immunology (2020) 209:277–299
⁷ https://www.sciencedirect.com/science/article/abs/pii/0003996994900590
⁸ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1393211/
⁹ The Journal Of Infectious Diseases. VOL. 158, NO.4. October 1988
¹⁰ Protected under patents both issued and pending.
¹¹ Exogenesis Hernia Mesh received FDA 510(k) premarket clearance September 26, 2019
¹² 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
¹³ "Past, Present and Future of Surgical Meshes: A Review" - Membranes (Basel). 2017 Sep; 7(3): 47.

SOURCE nanoMesh LLC

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