NASHUA, N.H.--(BUSINESS WIRE)--Vallum Corporation, a medical device company, today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) to market a polyetheretherketone (PEEK) spinal interbody fusion device with a PEEKplus® nanotextured1 surface created by Vallum’s proprietary and patented Accelerated Neutral Atom Beam (ANAB) technology.
Exogenesis Corporation Announces the Filing of a 510(k) Pre-Marketing Notification Application with the US Food and Drug Administration for Exogenesis Hernia Mesh
BILLERICA, Mass., July 24, 2019 /PRNewswire/ -- Exogenesis Corporation announced today that it has successfully completed filing of a Pre-Marketing Notification Application (510(k)) with the US Food and Drug Administration (FDA) for its first proprietary soft tissue repair device, Exogenesis Hernia Mesh. Exogenesis expects feedback from the FDA during the next quarter and anticipates entering the US market with Exogenesis Hernia Mesh following FDA premarket clearance.
BILLERICA, Mass., April 22, 2020 /PRNewswire/ -- Exogenesis announces today, the formation of nanoMesh LLC, a medical device company focused on commercialization of the Exogenesis Hernia Mesh ("nanoMesh"), an innovative soft tissue repair implant. nanoMesh possesses a unique nanometer-level surface texture, enabling favorable post implant tissue compatibility via the application of Accelerated Neutral Atom Beam (ANAB) technology during manufacturing.
BILLERICA, Mass., Oct. 8, 2020 /PRNewswire/ -- Exogenesis Corporation today announced that a series of challenge tests for the Exogenesis Surgical Mask (ESM) achieved its primary endpoints of trapping and deactivating COVID-19 viral particles in simulated real-world exposures.
.3M hernia repairs in the US annually – one of the most common surgeries. $1B U.S. market for hernia repair devices. 9% growth supported by aging population and obesity epidemic
Exogenesis Corporation is commercializing proprietary nanoscale surface modification and control technology which has application in improving the safety and performance of implantable medical devices.
Surface treatment with the NanoAccelTM surface modification process* leads to accelerated cell attachment and proliferation which in turn leads to enhanced tissue integration