U.S. Department of Defense Transfers 510(k) for RSDL to E-Z-EM.
LAKE SUCCESS, N.Y. -- E-Z-EM Inc. (Nasdaq:EZEM) today announced that it has received transfer of 510(k) application title for the Company's RSDL(TM)skin decontaminant from the U.S. Department of Defense (DoD). The transfer is the first of its kind, and represents a major enhancement of the company's ability to pursue expanded indications for the use of RSDL. The Company is the manufacturer and licensee of RSDL for use against chemical warfare agents, and now is the product's exclusive worldwide marketer for military and first responder organizations.
Commenting on the announcement, Anthony A. Lombardo, President and CEO of E-Z-EM, said, "The transfer of the 510(k) for RSDL to E-Z-EM's name is a major development in the commercialization of this product. The most immediate effect will be to significantly simplify the process of marketing RSDL to the First Receiver/First Responder marketplace. Over the long-term, possession of the 510(k) title will allow us to explore expanded indications for the product and other enhancements to our Healthcare Decontamination portfolio. We are very pleased to have worked with the DoD to affect this transfer, and will continue to work with them closely to provide products that make the battlefield a safer place for our warfighters."
The formal transfer occurred at a ceremony hosted by E-Z-EM at its main manufacturing facility. The event was attended by guests representing the entire 30-year development history of RSDL, including officials from the Office of the Under Secretary of Defense - US, the Joint Program Executive Office for Chemical and Biological Defense of the US DoD, Chemical & Biological Medical Systems, Defense Research and Development Canada (DRDC), Canadian Forces Health Services, the Canadian Parliament and others representing the U.S. and Canadian governments.
The DoD sponsored the original 510(k) application to the U.S. Food and Drug Administration (FDA) as a means of expediting regulatory review of the product. The FDA issued the 510(k) clearance for RSDL in March of 2003. The U.S. DoD began final configuration testing on the product in November of 2003 and authorized the sale of RSDL to first responder organizations in September of 2004. In September 2006, RSDL was awarded Safety Act certification by the U.S. Department of Homeland Security (DHS), which extends certain liability protections to the Company and its suppliers and customers (whether public or private) in the event RSDL is used in response to a terrorist incident.
RSDL is a patented, broad spectrum skin decontamination product intended to remove or neutralize chemical warfare agents or T2 toxins from the skin. RSDL was originally developed and patented by DRDC, an agency within the Canadian Department of National Defense, for use by the Canadian Forces. In addition to the U.S. DoD, RSDL has since been adopted by several military services around the world, including Canada, The Netherlands, Belgium, Ireland, Sweden, Slovenia, New Zealand, and Australia. RSDL is produced by E-Z-EM under a license with DRDC.
About E-Z-EM, Inc.
E-Z-EM, a publicly traded healthcare company founded in 1962, is one of the most recognized brands in diagnostic imaging of the GI tract. From the first barium contrast systems introduced over 40 years ago, to today's advanced products for CT imaging and virtual colonoscopy, E-Z-EM has continually developed innovative imaging and diagnostic solutions for physicians treating GI diseases. As a respected contract manufacturer of specialized liquid products, E-Z-EM has been the exclusive global manufacturer of RSDL since 1996. In April of 2005, E-Z-EM completed the acquisition of all assets associated with RSDL.
The statements made in this document contain certain forward-looking statements. Words such as "expects," "intends," "anticipates," "plans," "believes," "seeks," "estimates" or variations of such words and similar expressions, are intended to identify such forward-looking statements. The forward-looking statements contained in this release may involve numerous risks and uncertainties, known and unknown, beyond the Company's control. Such risks and uncertainties include: the ability of the Company to develop its products, the impact and future sales to the first receiver and first responder markets resulting from the transfer of the 510(k) title for RSDL to E-Z-EM from the U.S. DoD, future indications for RSDL and other enhancements to the Company's Healthcare Decontamination portfolio, if any, the impact on future sales of SAFETY Act designation and certification for RSDL, future orders of RSDL by first responder organizations, general military and first-responder market acceptance and sales of RSDL, future actions by the FDA or other regulatory agencies, overall economic conditions, general market conditions, price increases of raw materials and components, foreign currency exchange rate fluctuations as well as the risk factors listed from time to time in the SEC filings of E-Z-EM, Inc., including but not limited to its Annual Report on its Form 10-K for the fiscal year ended June 2, 2007. Consequently, actual future results may differ materially from the anticipated results expressed in the forward-looking statements, and investors are cautioned not to place undue reliance on the forward-looking statements included in this release.