Receipt of the CE Mark certifies that RSDL met the stringent European Union (EU) medical device requirements, has been labeled safe for its intended use, and can now be circulated freely within the 27 EU members.
These milestones enable us to put RSDL into the hands of those who truly need it," said Bill Scott, Senior Director of Sales, RSDecon.
Some military organizations and first responders (fire, police and emergency medical organizations including hospitals) already provide their members with RSDL for use in emergency situations involving a CW agent.
RSDL is a patented, broad spectrum skin decontamination product intended to remove or neutralize chemical warfare (CW) agents or T2 toxins from the skin.
RSDL received Milestone C approval from the Joint Program Executive Office for Chemical Biological Defense (JPEO-CBD).
In April of 2005, E-Z-EM completed the acquisition of all assets associated with RSDL, and now is the product's exclusive worldwide marketer to first-responder organizations and military services.
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.
The FDA issued the 510(k) clearance for RSDL in March of 2003.
Such risks and uncertainties include: the ability of the Company to develop its products, the impact and future sales, if any, resulting from the expansion of manufacturing capacity for RSDL
, 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.
As we also announced recently, the DoD has followed up its initial order of RSDL
with another order for approximately $8 million.
Department of Defense (DoD) since it issued Milestone C approval for the product, and is the largest single order for RSDL the Company has received to date.
Lombardo, President and CEO of E-Z-EM, said, "We are especially pleased with this order as the DoD has exceeded our original estimate for procurement of RSDL in the government's 2007 fiscal year.