Ascend Submits First FDA 510(k) for Clearance of Antimicrobial Technology for Surgical Masks

Houston-based Ascend Performance Materials recently submitted its first FDA 510(k) for clearance to market its patent-pending Acteev antimicrobial technology in the United States in a medical device—specifically, a surgical mask under new brand Acteev Biodefend. Independent laboratory testing has found Acteev materials to achieve greater than 99% efficacy at deactivating bacteria, fungi and viruses, including SARS-CoV-2. The 510(k) submission is for a surgical mask with one layer of Acteev Biodefend specialty nylon nonwoven fabric.

Covered by more than 15 patent families, Acteev technology embeds active zinc ions into the matrix of a specialty polymer. The technology  has been tested in multiple end forms, including knit and woven fabrics; engineered plastics; and nanofiber, meltblown and spunbond nonwoven materials. “We’ve partnered with independent labs for comprehensive testing and have reallocated resources to ready ourselves for world-scale production upon receiving regulatory clearance,” said Ascend’s CEO Dr.Vikram Gopal.

Acteev Biodefend technology has been shown in laboratory tests to deactivate SARS-CoV-2, the coronavirus that causes COVID-19, and other pathogens including H1N1, coronavirus 229E and Gram-positive and Gram-negative bacteria such as staphylococcus and E. coli. The testing was conducted following the protocols of ISO, ASTM or other international standards organizations.

“What is unique about Acteev is the marriage between the antimicrobial ingredient like zinc and the specialty polymer that keeps the zinc ions active and bound at all times. Because it isn’t a simple topical finish or coating, the antimicrobial protection can last much longer – it will not flake off or be worn away. And, unlike some other antimicrobials, zinc is environmentally friendly,” said Dr. Gopal. He ventures that Acteev Biodefend could provide an answer to the calls to identify an immediate, positive solution to restart the economy and reopen our schools and universities safely.

“The current global scarcity of pathogen-resistant materials is not going to end unless scientists and engineers look for novel ways to face the challenge, and we are proud to submit Acteev Biodefend as a potential solution,” Dr. Gopal said.

In early June, Ascend launched Acteev Protect, an antimicrobial line of protection specially formulated to guard against the growth of fungi, bacteria and other microbes to keep textiles and nonwoven fabrics fresher for longer. Acteev Protect, available for sale today in the United States and select other jurisdictions, can be used to make face coverings, filtration devices, and textiles for upholstery and apparel such as activewear. The company will soon offer nylon 66 compounds made with Acteev for use in injection molding applications.