FDA clears Quick-Med's Stay Fresh medical textile product

FDA granted 510k clearance for the Stay Fresh antibacterial skinfold management textile, which provides durable protection against bacterial contamination for skinfold management in bariatric patients.

"We are very pleased to have received this clearance for both prescription (Rx) and Over-The-Counter (OTC) use," said Bernd Liesenfeld, Quick-Med's President. "This clearance represents a very powerful validation of our Stay Fresh technology, since the FDA review process is extremely meticulous and comprehensive; 510k clearance requires strong evidence of both effectiveness and of safety for users and care providers.

"Together with the existing EPA registration for Stay Fresh this provides strong regulatory support for our products already in development with partners, and for further products in our pipeline, both on the consumer and on the medical sides."

"Areas of skin-to-skin contact such as under breast folds or abdominal skin folds frequently develop redness, odor, and rashes due to increased moisture and friction that create an environment that promotes bacterial growth in the skin folds," said Professor Gregory Schultz, Director of the Institute for Wound Research and Professor of Obstetrics and Gynecology at the University of Florida. "The Stay Fresh antibacterial textile approved by the FDA provides an effective skin fold management system that will help manage moisture and bacterial pathogen growth for up to 5 days."

About Stay Fresh

Stay Fresh is Quick-Med's newest technology platform. This technology is based on hydrogen peroxide -- a well known consumer antimicrobial product that is commonly used in households for disinfecting cuts, scrapes, toothbrushes and more. Hydrogen peroxide is also produced by human cells to combat invasive bacteria, and is a naturally occurring preservative component of milk and honey.

EPA has registered Stay Fresh to be utilized to protect a broad selection of treated goods for consumer use, including textiles, decorative fabrics, and functional fabrics such as filters and carpets. FDA has granted clearance to market an antibacterial medical textile based on Stay Fresh Technology.

The Stay Fresh technology offerings provided by Quick-Med are expanding continuously, with development of additional applications including antimicrobial surface treatments, and superabsorbent antimicrobial powders to complement the range of products that are already cleared for consumer use under EPA or FDA jurisdiction.

About Quick-Med Technologies, Inc.

Quick-Med Technologies, Inc. is a life sciences company that is developing and commercializing proprietary, broad-based technologies for the consumer and healthcare markets. The Company's NIMBUS technology is the first FDA-cleared, non-leaching antimicrobial technology available in a wound dressing.

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