SAN DIEGO, Jan. 27 /PRNewswire-FirstCall/ -- Cardium Therapeutics and its operating unit InnerCool Therapies today announced the launch of InnerCool's newly redesigned website at www.innercool.com. The updated and expanded website highlights InnerCool's new RapidBlue(TM) high-performance endovascular temperature modulation system, its CoolBlue(TM) surface system, and CoolConnect Adapters to allow CoolBlue surface pads to be used with other hypothermia consoles.
"The new website provides enhanced visual content and a more comprehensive overview of InnerCool's new products. InnerCool is believed to be the only Company in the U.S. and internationally focused on the development of a diverse portfolio of best-in-class temperature modulation therapy products for multiple vertical market opportunities. We have endovascular and surface-based systems, and advanced low-profile, flexible catheters with fully integrated temperature sensors, all of which have FDA 510(k) clearances and CE marks. In addition, in November 2008, we announced the UroCool System, an investigational targeted tissue cooling system that has initially been developed for robotic-assisted and traditional prostate surgeries. This pelvic cooling technology platform has the opportunity to be further expanded into other clinical applications. At the same time, we are working on our CoolFuse System for use in the hospital setting and by emergency medical services (EMS)," stated Christopher J. Reinhard, Chairman and Chief Executive Officer of Cardium Therapeutics and InnerCool Therapies.
RapidBlue(TM) Endovascular Temperature Modulation System
The RapidBlue System includes a programmable console with an enhanced user-friendly interface and touch panel screen and powers the low profile flexible Accutrol(R) catheter to quickly modulate patient temperature at cooling rates of 4-5 degrees Celsius per hour or warming rates of 2-3 degrees Celsius per hour. The Accutrol catheter, which has a flexible metallic temperature control element (TCE(R)) and a built-in temperature feedback sensor to provide fast and precise patient temperature control, can accurately measure core body temperature within 0.1 degree Celsius. Its novel software control algorithm provides automated and precise body temperature control, eliminating the use of peripheral temperature probes which are generally slow in responding to core temperature changes.
The RapidBlue console and Accutrol catheter can quickly and accurately modulate whole body temperature without introducing or exchanging any fluid within the body. The system functions by programmably circulating cold or warm saline in a closed circuit within the catheter to either cool or warm its outer metallic surface, which effectively conducts heat out of or into the surrounding bloodstream. The unique design of InnerCool's TCE(R), which is both thermally conductive and includes alternating surface helices to promote mixing around the TCE, further enhances heat transfer and enables rapid patient temperature modulation, even in obese patients. The catheter and TCE have a covalently-bonded heparin coating for hemo-compatibility and the catheter can be readily inserted intravenously while the patient is in an operating room or intensive care setting without the need for continuous fluoroscopy. The integrated temperature sensor allows for automated temperature management, and also eliminates the need to place bladder or other patient temperature probes which can be slow to react to changes in core body temperature, and may be uncomfortable to the patient and time-consuming to place.
Other currently-marketed endovascular systems rely on plastic-based balloon catheters that are inflated after placement in the bloodstream. Although expansion of the balloons increases their overall surface area for heat transfer, it also tends to make the catheters fairly large and rigid. In addition, they do not contain integrated temperature feedback sensors and heat transfer is limited by the very poor conductive nature of plastic. In terms of performance, a medium-sized balloon-based catheter which inflates to about 8 mm (24 French) has been reported to cool intubated, paralyzed patients at a rate of around 1 degree Celsius per hour. Patients who are intubated and paralyzed or under general anesthesia are the least difficult to cool as they cannot respond to physiological changes in body temperature through shivering. In comparison, InnerCool's RapidBlue System combines an ultra-thin flexible metallic catheter of only 3.5 mm (10.7 French) or 4.6 mm (14 French) with the potential to achieve cooling rates that are approximately 4-fold faster, i.e. about 1 degree Celsius per 15 minutes in similar patients. Rapid cooling is considered to be particularly important for preserving tissue and organ function under conditions of acute ischemia, which result from reduced blood flow to critical tissues and organs.
The RapidBlue System can be used in inducing, maintaining and reversing mild hypothermia in neurosurgical patients, both in surgery and in recovery or intensive care. The system can also be used for cardiac patients in order to achieve or maintain normal body temperatures during surgery and in recovery / intensive care, and as an adjunctive treatment for fever control in patients with cerebral infarction and intracerebral hemorrhage. Potential additional applications of the technology include endovascular cooling for cardiac arrest (resuscitation), acute ischemic stroke, myocardial infarction (heart attack) and trauma.
CoolBlue(TM) Surface Temperature Modulation System
InnerCool's CoolBlue surface temperature modulation system, which includes a console and a disposable CoolBlue vest with upper thigh pads, is designed to provide a complementary tool for use in less acute patients or in clinical settings best suited to prolonged temperature management. InnerCool's CoolBlue vest and thigh pads wrap the body without requiring any adhesives to stick to the skin and produce cooling rates of around 1 degree Celsius per hour, i.e. similar to those of currently-marketed surface cooling systems and endovascular systems using inflatable balloon-based catheters. InnerCool's CoolBlue external or surface-based temperature modulation system is designed to cool or warm patients from outside of their bodies and is intended for use in less acute settings such as in-hospital fever management. InnerCool's nurse-friendly and cost-effective CoolBlue surface temperature modulation system, launched in the U.S. in fourth quarter 2007, is also now available for sale in Europe and Australia through recently-completed distributorship agreements.
UroCool(TM) Pelvic Catheter System
InnerCool's UroCool(TM), a pelvic catheter system designed to induce localized cooling during robotic-assisted prostatectomy surgery, is currently under development and being utilized by Thomas E. Ahlering, M.D., Professor and Vice Chair of the Department of Urology and his colleague Dr. David S. Finley M.D. in studies being conducted at the University of California, Irvine. Previous findings by the researchers using localized manual cooling techniques during robotic-assisted radical prostatectomy surgery indicated that cooling resulted in a significantly faster recovery of urinary continence following surgery. A regulatory application for FDA 510(k) clearance of InnerCool's UroCool catheter is expected to be submitted in the first quarter of 2009. The UroCool(TM) catheter is designed to be placed within the rectal cavity adjacent to the prostate during surgery and is used in conjunction with InnerCool's Celsius Control Console which circulates cold saline in a closed loop within InnerCool's UroCool catheter to allow for localized cooling. It is believed that therapeutic cooling of the prostate gland and surrounding areas during prostate surgery (which includes both traditional open surgical approaches and the newer robotic-assisted technique) offers the potential to reduce tissue damage and inflammation and thereby provide a faster return of bladder control (continence) and possibly erectile function (potency) following surgery.
CoolFuse(TM) Infusion System
InnerCool's new CoolFuse(TM), also in development, is a pressurized infusion system for cooling and warming patients en route to the hospital in an emergency vehicle, as well as in the hospital setting to start the induction of hypothermia prior to implementation of endovascular or surface cooling. CoolFuse will be marketed to EMS agencies and hospitals, which are increasingly implementing cooling protocols for post cardiac arrest patients in accordance with guidelines of the American Heart Association and other agencies involved in resuscitation. Researchers have found that cold saline infusions (3 degrees Celsius) can lower core body temperature in transport.
Cardium Therapeutics, Inc. and its subsidiaries, InnerCool Therapies, Inc. and the Tissue Repair Company, are medical technology companies primarily focused on the development, manufacture and sale of innovative therapeutic products and devices for cardiovascular, ischemic and related indications.
Cardium's InnerCool Therapies subsidiary is a San Diego-based medical technology company in the emerging field of temperature modulation therapy to rapidly and controllably cool the body in order to reduce cell death and damage following acute ischemic events such as cardiac arrest or stroke, and to potentially lessen or prevent associated injuries such as adverse neurological outcomes. For more information about Cardium's InnerCool subsidiary and patient temperature modulation, including InnerCool's new RapidBlue(TM) System, which just received FDA clearance, and its CoolBlue(TM) System, please visit www.innercool.com.
Cardium also has two biologic candidates in clinical development. Cardium's Tissue Repair Company subsidiary (TRC) is focused on the development of growth factor therapeutics for the treatment of severe chronic diabetic wounds. TRC's lead product candidate, Excellarate(TM), is a DNA-activated collagen gel for topical treatment formulated with an adenovector delivery carrier encoding human platelet-derived growth factor-BB (PDGF-BB). Excellarate(TM) is initially being developed to be administered once or twice for the potential treatment of non-healing diabetic foot ulcers. Other potential applications for TRC's Gene Activated Matrix(TM) (GAM) technology include therapeutic angiogenesis (cardiovascular ischemia, peripheral arterial disease) and orthopedic products, including hard tissue (bone) and soft tissue (ligament, tendon, cartilage) repair. For more information about Cardium's Tissue Repair Company subsidiary, please visit www.t-r-co.com.
Cardium's Generx product candidate (alferminogene tadenovec, Ad5FGF-4) is a DNA-based growth factor therapeutic being developed for potential use by interventional cardiologists as a one-time treatment to promote and stimulate the growth of collateral circulation in the hearts of patients with ischemic conditions such as recurrent angina. For more information about Cardium Therapeutics and its businesses, products and therapeutic candidates, please visit www.cardiumthx.com or view its last Annual Report at http://www.cardiumthx.com/flash/pdf/CardiumAR07_Book_FINAL.pdf.
Except for statements of historical fact, the matters discussed in this press release are forward looking and reflect numerous assumptions and involve a variety of risks and uncertainties, many of which are beyond our control and may cause actual results to differ materially from stated expectations. For example, there can be no assurance that temperature modulation therapies will gain increasing acceptance and use, that alternatives to InnerCool's products will not be perceived as better, safer or less expensive, that results or trends observed in one clinical study will be reproduced in subsequent studies, that necessary regulatory approvals will be obtained, or that our own actual or proposed products and treatments will prove to be sufficiently safe and effective and will gain market acceptance. Actual results may also differ substantially from those described in or contemplated by this press release due to risks and uncertainties that exist in our operations and business environment, including, without limitation, our limited experience in the development, testing and marketing of therapeutic hypothermia devices and whether our efforts to launch new devices and systems will be successful or completed within the time frames contemplated, risks and uncertainties that are inherent in the conduct of human clinical trials, including the timing, costs and outcomes of such trials, our dependence upon proprietary technology, our history of operating losses and accumulated deficits, our reliance on collaborative relationships and critical personnel, and current and future competition, as well as other risks described from time to time in filings we make with the Securities and Exchange Commission. We undertake no obligation to release publicly the results of any revisions to these forward-looking statements to reflect events or circumstances arising after the date hereof.
Copyright 2009 Cardium Therapeutics, Inc. All rights reserved.
Cardium Therapeutics(TM) and Generx(TM) are trademarks of Cardium Therapeutics, Inc.
Tissue Repair(TM), Gene Activated Matrix(TM), GAM(TM) and Excellarate(TM) are trademarks of Tissue Repair Company.
InnerCool Therapies(R), InnerCool(R), Celsius Control System(R), RapidBlue(TM), CoolBlue(TM). Accutrol(R), Temperature Control Element(R) and TCE(R) and UroCool(TM) are trademarks of InnerCool Therapies, Inc.
(other trademarks belong to their respective owners)
CONTACT: Bonnie Ortega, Director, Investor/Public Relations of Cardium
Therapeutics, Inc., +1-858-436-1018, InvestorRelations@cardiumthx.com
Web site: http://www.innercool.com/