RADNOR, Pa. -- Sterilox Technologies, Inc. announced today that it has received clearance of its 510(k) from the Food and Drug Administration (FDA) to market its Sterilox Liquid Chemical High Level Disinfectant System. The company plans to launch the product in the United States over the coming months. The Sterilox System has been marketed in Europe since 1999.
The Sterilox Liquid Chemical High Level Disinfectant (HLD) System, developed and patented by Sterilox Technologies, Inc., is a proprietary system that delivers to the end user a highly effective, non-toxic and biodegradable disinfectant from a proprietary, Sterilox designed, generator. The Sterilox HLD is the first new chemistry cleared by the FDA for the High Level Disinfection of heat sensitive instruments since 1999 and will provide a fast, safe, non-toxic alternative to the current users of HLD's. Sterilox's technology is based on the electrochemical activation of dilute brine solutions. The HLD produced is single-use and generated on-site and on demand at the point of use in hospitals, out-patient clinics and doctors' offices; any location in which rapid, high level disinfection of devices such as flexible endoscopes is required.
The Sterilox solution can be used in all standard washer/disinfectors or in manual systems to high level disinfect well-cleaned endoscopes or other heat sensitive systems. The Sterilox experience outside the US has focused on endoscopy suites, where the company's technology has successfully disinfected over 500,000 devices since its launch in 1999.
"The addition of the Sterilox System to the current HLD's available in the endoscopy suite and other appropriate locations will allow the U.S. to take advantage of the technology that has become one of the standards of care in markets outside the U.S., especially in the U.K.," said David W. Anderson, Sterilox Technologies president and CEO. "We are pleased with this action at FDA and look forward to the introduction of our technology to the U.S. market and to supplying the endoscopist with a new tool allowing them to provide safe and effective treatments to their patients."
Sterilox Technologies, Inc. is a leading developer and marketer of sterilization and disinfection generators and their solutions (Sterilox, Aqualox) based on the proprietary electrochemical activation of dilute brine solutions.