Agion Antimicrobial (AM) by Sciessent, a US based provider of antimicrobial solutions based on naturally occurring elements, has been incorporated into FDA cleared N95 respirator masks, the type most in-demand in the fight against the COVID-19 pandemic. As of 31 March 2020, over 3 million Nexera SpectraShield 9500 masks incorporating Agion AM have been delivered to healthcare facilities worldwide.
According to the company, the Nexera SpectraShield surgical respirator was cleared by NIOSH and received an updated 510(k) from the Food and Drug Administration (FDA) in 2015 with approved claims to inactivate viruses by 99.99% in 5 minutes and kill 99.99% of bacteria in one hour. It has also been cleared in Canada and the European Union, Sciessent adds.
“Following the viral outbreaks of the early 2000s, Sciessent engaged with university researchers, industry partners and government organizations to investigate the ability of Agion to inactivate viruses,” said Paul Ford, CEO, Sciessent. “Once Agion AM’s anti-viral efficacy was proven, Sciessent worked with Foss Performance Materials to develop a polyester fibre, named Fossshield, with Agion AM embedded into the FPM fibre itself. The FPM media was then manufactured into N95 respirator masks sold by Nexera Medical.”
The Nexera mask is constructed from two layers of FPM nonwoven with a filtration membrane between them. Agion AM is in the FPM nonwoven in both the inner and outer surface of the Nexera mask, the company explains.
“We chose the Agion AM solution first and foremost for its efficacy, which when combined with FPM’s nonwoven design expertise, results in a mask sold by Nexera Medical and others that provides extraordinary protection to those on the front lines of virus response,” said Steve Polston, President, Nonwovens for Foss Performance Materials.
“In addition, Sciessent leveraged their deep bench of expertise in the medical device market to provide support to FPMs throughout product development and the FDA approval process, which proved key to Nexera receiving approvals.”
According to Sciessent, the Agion Antimicrobial is presently registered by the United States Environmental Protection Agency as a preservative and bacteriostatic agent for use in treated articles under 40 CFR 152.25a. “The information presented herein is not intended to support or endorse public health claims for treated articles. The Agion Antimicrobial is also used in medical devices under the Food and Drug Administration; those medical device claims are based on safety and efficacy testing and are limited to those approved by FDA,” the company concludes.