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Cardium's InnerCool Reports on Expanding Use of Therapeutic Hypothermia

First Responders Leading the Charge of Cooling Therapy for Cardiac Patients

SAN DIEGO, Jan. 29 /PRNewswire-FirstCall/ -- Cardium Therapeutics (NYSE Alternext US: CXM) and its operating unit InnerCool Therapies today reported on the growing trend of the country's first responders leading the charge and adopting therapeutic hypothermia protocols for cardiac arrest patients. Newly emerging protocols recommend that cardiac arrest patients be quickly cooled, beginning even before they reach the hospital, and that they be transported to hospitals with therapeutic cooling systems in place. Emergency Medical Services (EMS) providers have implemented therapeutic cooling protocols in a number of major U.S. cities including Seattle, WA, Boston, MA, Raleigh, NC, Houston, TX, Phoenix, AZ and New York, NY. As recently reported by the New York Times, effective January 1, 2009, New York City ambulances are required to take post-cardiac arrest patients to hospitals that have adopted therapeutic hypothermia protocols. These changes in the standard of care follow a growing number of reports regarding the importance of cooling in the treatment of cardiac patients.


American Heart Association

On December 2, 2008, the American Heart Association (AHA) reported further on this emerging trend in a scientific consensus statement entitled "Post Arrest Syndrome. Epidemiology, Pathophysiology, Treatment, and Prognostication." in the journal of Circulation. As noted, "Preclinical and clinical evidence strongly supports mild therapeutic hypothermia as an effective therapy for the post-cardiac arrest syndrome. Unconscious adult patients with spontaneous circulation after out-of-hospital VF cardiac arrest should be cooled to 32 degrees Celsius to 34 degrees Celsius for at least 12 to 24 hours. Most experts currently recommend cooling for at least 24 hours. Although data support cooling to 32 degrees Celsius to 34 degrees Celsius, the optimal temperature has not been determined. Induced hypothermia might also benefit unconscious adult patients with spontaneous circulation after out-of-hospital cardiac arrest from a nonshockable rhythm or in-hospital cardiac arrest. Although the optimal timing of initiation has not been defined clinically, current consensus is to initiate cooling as soon as possible."

Temperature modulation therapy to safely and effectively cool patients represents an important new tool that is beginning to be utilized for protecting the brain from ischemia, especially in post-cardiac arrest patients who are at higher risk of brain tissue damage due to the prolonged lack of blood flow. With the increase in survival of cardiac arrest victims resulting from the advent of automated external defibrillators, cooling patients is the next logical therapeutic approach especially in light of the large body of supporting scientific literature, and guidelines issued by the AHA and the International Liaison Committee on Resuscitation recommending that cardiac arrest victims be treated with induced hypothermia.

Cardiology News and Other Reports

Therapeutic hypothermia has been increasingly in the news and is now beginning to become a standard of care in a growing number of hospitals and emergency medical centers. In an article entitled "Cooling for Cardiac Arrest Catches On" in Cardiology News, Mary Ann Peberdy, Professor of Medicine and Emergency Medicine at Virginia Commonwealth University in Richmond summarized these trends, noting that "there has been a major shift in the use of therapeutic hypothermia. We've seen a substantial increase in interest so that at the start of 2009 there is generally at least one large center routinely using therapeutic hypothermia for cardiac arrest patients in virtually every major U.S. metropolitan area."

In a November 4, 2008 article entitled "Raising the Dead: Prehospital hypothermia for cardiac arrest victims may improve neurological outcome and survival to discharge", authors Mike Clumpner and Jim Mobley, early adopters of pre-hospital hypothermia therapy for cardiac arrest patients, commenting on Regional One Air Medical Service in South Carolina's therapeutic hypothermia protocol implemented in 2005, noted that "therapeutic hypothermia offers many proven benefits for the post-cardiac arrest patient if hypothermia is induced within the first 15 minutes following resuscitation and therapeutic temperature is achieved within two hours." The authors also noted, "Because therapeutic hypothermia was researched thoroughly and fully endorsed by the AHA without specific reference to in-hospital versus out-of-hospital initiation, we felt it would be beneficial to adopt the complete resuscitation algorithm at our service. Like many others, we felt it would be unethical to withhold a proven treatment from our patients."

"We are pleased to see EMS agencies and others encouraging the paradigm shift in the healthcare system as they increasingly incorporate therapeutic cooling into their current standard practices," stated Christopher J. Reinhard, Chairman and Chief Executive Officer of Cardium Therapeutics and InnerCool Therapies. "There is a tremendous opportunity in this market considering that only an estimated 100 out of 24,000 EMS agencies in the United States have instituted cooling protocols for post cardiac arrest patients. With InnerCool's new RapidBlue in-hospital cooling system, and CoolFuse, a pressurized infusion system being developed for cooling in emergency vehicles and emergency rooms, InnerCool will be well positioned to provide EMS agencies around the country with the system they need to initiate cooling of cardiac arrest patients en route to the hospital, and to effectively complete and maintain cooling once patients reach the hospital."

RapidBlue(TM) Endovascular Temperature Modulation System

InnerCool's RapidBlue system for high-performance endovascular temperature modulation 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 anesthetized intubated (i.e. surgical) patients at a rate of around 1 degrees Celsius per hour. 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 degrees Celsius per 15 minutes. 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 may 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 degrees 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 CoolBlue nurse-friendly and cost-effective 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, also in development, is a pressurized infusion system for cooling and warming patients en-route to the hospital and in the emergency room. The CoolFuse will be provided to EMS agencies and hospitals to rapidly cool post cardiac arrest patients. Researchers have found that cold saline infusions (3 degrees Celsius) can lower core body temperature in transport.

About Cardium

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

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

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 or view its most recent Annual Report at

Forward-Looking Statements

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.

For Terms of Use Privacy Policy, please visit

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)

SOURCE Cardium Therapeutics
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