NanoHorizons Inc., a leader in the development of nanoscale additives for healthcare, textile and industrial applications, has announced the submission of a Device Master File (MAF) to the U.S. Food and Drug Administration (FDA) for a proprietary formulation of SmartSilver® antimicrobial additives.
NanoHorizons’ nanoscale silver additives leverage silver’s long established antimicrobial properties to produce a highly durable, broad spectrum antimicrobial that is integration-ready for a wide range of medical applications. Developed and manufactured in the U.S., SmartSilver® can be readily integrated into a wide range of polymers, coatings, foams and fibers to control the growth of bacteria, fungus and mold in devices, textiles and touch surfaces.
The NanoHorizons Device Master File provides technical, manufacturing, and biocompatibility information about SmartSilver®, facilitating the FDA review of antimicrobial-treated medical devices and combination product candidates that reference the use of this antimicrobial additive. SmartSilver® additives can be integrated into virtually all surfaces and fabrics and, as such, can be used, pending regulatory approval, in a wide variety of medical-related equipment, wound care products, and infrastructure components, including instruments, bandages, scrubs and room textiles, footwear, wall and floor coverings, and bed frames and mattress tickings, to name a few.
“As more antimicrobial products treated with SmartSilver® move into the FDA approval pipeline, our MAF will help in expediting our customers’ product reviews and approval by the agency,” explains David Woodle, CEO of NanoHorizons. “And from our business perspective, it more quickly opens a market that has a high interest in and need for our advanced antimicrobial solutions.”
SmartSilver® nanoscale additives do not impact the mechanical properties of coatings or polymers due to their minute particle size. And, in contrast to ion exchange based antimicrobials, NanoHorizons’ metallic nanoscale silver exhibits highly stable and controlled silver ion release in the presence of physiological fluids and electrolytes. SmartSilver® is also stable against UV light and high temperatures. Third party review of independent toxicology laboratory data from NanoHorizons additives has been certified as being free of harmful substances according to the Oeko-Tex® 100 standard