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
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