Ascend Performance Materials Submits Its First 510(k) to FDA
Ascend Performance Materials has applied for U.S. Food and Drug Administration approval to market its Acteev technology in a pair of high-efficacy surgical masks to protect against SARS-CoV-2, the coronavirus strain that causes COVID-19.
The Houston-based company also recently 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 a longer period of time. Acteev Protect, now available in the United States and select other jurisdictions, can be used to make personal protection equipment like face coverings, filtration devices and textiles for apparel, such as activewear, and upholstery.
Acteev Protect combines zinc ion technology with polyamide-based woven, nonwoven and knit fabrics. The active zinc ions are embedded into the polymer matrix, providing a long-lasting solution that does not wash away.
“Bacteria, mildew and other microbes growing on fabrics and filters cause the item to break down, discolor and give off unpleasant smells,” Dr. Lu Zhang, Ascend’s vice president leading the Acteev launch, said. “Acteev Protect guards against that microbial growth, keeping the articles clean.”
The Acteev masks come in a nanofiber and a microfiber nonwoven version, each branded under the Acteev Biodefend line for medical devices, deliver both antiviral properties and top-level barrier protection against microbes, harmful airborne particles and fluid splatter.
Acteev technology has been shown in laboratory tests to deactivate SARS-CoV-2, the coronavirus that causes COVID-19, and other pathogens including H1N1, betacoronavirus OC43, human coronavirus 229E and Gram-positive and Gram-negative bacteria such as staphylococcus and E. coli, according to Dr. Vikram Gopal, Ascend’s chief technology officer. The testing was conducted following the protocols of ISO, ASTM or other international standards organizations.
The proposed masks also meet the requirements to qualify as Level III under ASTM F2100-19 standards, as tested by independent laboratories as well as Ascend scientists. Level III is the highest tier for physical barrier and safety properties, according to the common international testing standard.
Gopal said the combination of superior physical properties and antiviral protection is a breakthrough in medical device technology, as many masks succeed either at antiviral protection or at filtration and barrier effectiveness but not at both.
“Previous technologies rely on the materials within a mask to retain an electrical charge to achieve filtration efficiency,” he said. “But when antimicrobial agents are added, those materials lose their charge and begin to fail as barriers.”
Acteev masks, however, achieve antiviral effectiveness through active zinc ions embedded within the polymer structure of polyamide 66, a hygroscopic nylon material whose equilibrium moisture keeps the zinc ions active.
“With Acteev, we have cracked the code of balancing top physical performance with antiviral protection,” Gopal added.
The technology, covered by more than 15 patent families, has been tested in multiple end forms, including knit and woven fabrics, engineered plastics, and nanofiber meltblown, microfiber meltblown and spunbond nonwoven materials.
Ascend Performance Materials is a global premium provider of high-quality plastics, fibers and chemicals. Headquartered in Houston, 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 innovation and safe production.