SAN DIEGO, July 14 Cardium Therapeutics(Amex: CXM) and its operating unit InnerCool Therapies, Inc., announced todaythat InnerCool's RapidBlue(TM) endovascular temperature modulation systemconforms to the European Union CE Mark requirements for use in inducing,maintaining and reversing mild hypothermia in a variety of clinicalindications including cardiac arrest, neurosurgery, fever, cardiovascularre-warming, trauma re-warming, and potential additional applications includingacute ischemic stroke and myocardial infarction (heart attack). The CE Markwill allow the Company to begin marketing the RapidBlue system in Europe andmany other countries that recognize the certification. The Company expects tobegin selling the RapidBlue System through its established distributionnetwork next quarter. As previously reported, InnerCool's RapidBlue System iscurrently under review for FDA 510(k) clearance.
"We believe our RapidBlue System is truly the most dynamic andbest-in-class temperature modulation system on the market and receiving CEMark and UL certification demonstrates that the Company has established andoperates a world class quality system. Based on our three year developmenteffort, InnerCool's RapidBlue System establishes new performance standards bywhich all other endovascular and surface systems on a worldwide basis will nowbe judged," stated Christopher J. Reinhard, Chairman and Chief ExecutiveOfficer of Cardium Therapeutics and InnerCool Therapies. "This is the firstUL global certification for an endovascular thermal regulating system andfurther confirms the technology leadership position that InnerCool isestablishing with the RapidBlue System. With commercialization agreements inplace with leading distributors in the European Union, we look forward toexpanding our distribution activities to include our RapidBlue System."
InnerCool's RapidBlue System is a thermal regulating system designed tomanage and control patient body temperature. The system automatically coolsor warms patients, as necessary, to maintain desired body temperature.RapidBlue provides rapid or gradual temperature control for all patient sizesand its closed loop catheter based system modulates whole body temperaturewithout fluid introduction or exchange by circulating cool or warm salinewithin the interior of the catheter. Unlike various other systems, RapidBlueis powerful enough to quickly cool awake patients and can eliminate the needto use paralytic agents. The system includes a programmable console with anenhanced user-friendly interface and touch-panel screen.
The RapidBlue System powers InnerCool's low-profile flexible Accutrol(R)catheter which can quickly modulate patient temperature at cooling rates of4-5 degrees Celsius per hour. The Accutrol catheter contains an integratedtemperature sensor capable of accurately measuring core body temperature towithin 0.1 degree Celsius of pulmonary artery temperature. Its novel softwarecontrol algorithm provides automated and precise body temperature control,eliminating the use of peripheral temperature probes which are generally slowto respond to changes in core body temperature.
The Company also announced that Underwriters Laboratories, Inc. (UL)completed a national and international conformity assessment for the RapidBlueSystem and concluded that it meets all of the applicable requirements of theU.S. (UL 60601-1), Canadian (CSA C22.2 No. 601.1-M90), and European Union(EN60601-1) medical electrical safety standards. In addition, the RapidBlueconsole passed the stringent UL 471 Standard for commercial refrigerators andfreezers.
InnerCool's RapidBlue(TM) and CoolBlue(TM) Temperature Modulation Systems
InnerCool's RapidBlue system for high-performance end