Ascend files first FDA 510(k) submission based on ActeevTM technology
Data from independent labs find Acteev deactivates bacteria, fungi and viruses, including SARS-CoV-2
HOUSTON – June 30, 2020 – Ascend Performance Materials announced today it submitted its first FDA 510(k) for clearance to market its patent-pending ActeevTM technology in the United States in a medical device, a surgical mask under a new brand called 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.
“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 Vikram Gopal, Ph.D., Ascend’s chief technology officer.
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, Dr. Gopal said. The testing was conducted following the protocols of ISO, ASTM or other international standards organizations.
Acteev technology, covered by more than 15 patent families, embeds active zinc ions into the matrix of a specialty polymer.
“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,” Dr. Gopal said. “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.”
Acteev technology has been tested in multiple end forms, including knit and woven fabrics; engineered plastics; and nanofiber, meltblown and spunbond nonwoven materials.
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, Dr. Gopal said.“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.
Earlier this month, 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
• Tests show >99% antiviral, antibacterial, antifungal efficacy
• EPA-registered zinc ions embedded in the polymer
• Hygroscopic nylon 6,6 fabric attracts moisture, which actives the zinc ions
• Not a topical treatment or coating
• Not dependent on silver, copper
• Proven efficacy in many end forms:
o Knit and woven fabrics for consumer textiles, upholstery, uniforms, face masks
o Nanofiber, meltblown and spunbond nonwovens for filtration
o Fibers for carpets
o Engineered plastics for high-touch surfaces
DISCLAIMER: Acteev™ technology has been shown in laboratory tests to destroy 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. All data presented on this page comes from testing performed by independent third-party laboratories following the protocols of ISO, ASTM or other international standards organizations. Not all claims are permitted in all jurisdictions, including in the United States. Some device designs currently under review with the U.S. Food and Drug Administration — submission number K201714. Ascend has more than 15 patent families pending on Acteev technology.
About Ascend Performance Materials
Ascend Performance Materials is a global premium provider of high-quality plastics, fibers and chemicals and is the world’s largest integrated producer of PA66 resin. Headquartered in Houston, Texas, Ascend has nine global locations, including five fully-integrated manufacturing facilities located in the southeastern United States and an engineering plastics compounding facility in Europe, all dedicated to the innovation and safe production. With three of the world’s largest chemical processing facilities, Ascend’s materials form the building blocks for products used in everyday applications from apparel to airbags, cable ties to circuit boards and carpets to car parts. Ascend’s 2,600-person global workforce is committed to making a difference in the communities we serve and leading the development of material solutions that inspire everyone, everywhere, every day.
Together, we’re making a difference.
Together, we’re inspiring everyday.
More information about Ascend can be found at www.ascendmaterials.com