FDA Clears Quick-Med Technologies' Stay-Fresh® Medical Textile Product
Published: May 29, 2013
FDA Clears Stay-Fresh(R) Medical Textile Product
GAINESVILLE, FL--(Marketwired - May 29, 2013) - Quick-Med Technologies, Inc. (QMDT), a life sciences company that is developing innovative technologies for the healthcare and consumer markets, announced today that the U.S. Food and Drug Administration (FDA) has issued clearance for distribution and marketing of a 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. Its Stay Fresh® technology provides highly durable antimicrobial protection for apparel and other textile applications, with consumer applications of Stay Fresh Technology having EPA registration for the treated articles, as well as an FDA clearance for an antibacterial medical textile product. Quick-Med develops antimicrobial technologies to promote public health, safety and comfort. For more information, see: www.quickmedtech.com.
© 2013 Quick-Med Technologies, Inc. All rights reserved. NIMBUS®, and Stay Fresh® are registered trademarks of Quick-Med Technologies, Inc.
Forward-looking statements (statements which are not historical facts) in this release are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. For this purpose, any statements contained in this release that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, words such as "may", "will", "to", "expect", "plan", "believe", "anticipate", "intend", "could", "would", "estimate", and/or "continue" or the negative or other variations thereof or comparable terminology are intended to identify forward-looking statements involve risks and uncertainties, including those risks that are discussed in the Company's filings with the Securities and Exchange Commission ("SEC"), which may be accessed at the SEC's Edgar System at www.sec.gov.
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