SAN DIEGO, Dec. 5 /PRNewswire-FirstCall/ -- Cardium Therapeutics
(NYSE Alternext: CXM) and its operating unit InnerCool Therapies today
reported on New York City's adoption of procedures designed to promote
temperature modulation therapy for cardiac arrest patients, as featured in an
article in The
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 American Heart Association (AHA) and the International Liaison Committee on Resuscitation recommending that cardiac arrest victims be treated with induced hypothermia.
"With the AHA guidelines in effect and increasing national media coverage on temperature modulation therapy, we are finally beginning to see a paradigm shift by physicians and healthcare systems as they increasingly incorporate therapeutic cooling into the standard practice of medicine. As a result, new local community standards of care for cooling cardiac patients are being established across the nation by which hospitals will be judged and held accountable by patients, their families, and others if they do not establish cooling programs or fail to apply cooling therapy in accordance with the AHA guidelines," stated Christopher J. Reinhard, Chairman and Chief Executive Officer of Cardium Therapeutics and InnerCool Therapies.
Reinhard added, "InnerCool is continuing to develop new and innovative best-of-class medical devices based on our important technology position and expertise in the growing field of temperature modulation therapy. With our RapidBlue and CoolBlue systems now completed and FDA-cleared, and the new CoolFuse and UroCool systems in development, this should facilitate the expansion of use of InnerCool systems for current indications and facilitate ongoing research regarding the potential uses of temperature modulation in a number of different patient populations that could benefit from these new therapies."
About Patient Temperature Modulation
Patient temperature modulation is a rapidly-advancing field focused on preserving ischemic tissue and improving patient outcomes following major medical events such as cardiac arrest, heart attack and stroke, as well as in the management of patients experiencing trauma or fever. Internal or endovascular temperature modulation is intended to rapidly cool patients from within their bodies in order to reduce cell death and damage caused by acute ischemic events in which blood flow to critical organs such as the heart or brain is restricted, and to prevent or reduce associated injuries such as adverse neurologic outcomes.
Numerous scientific and medical articles have described the usefulness of temperature modulation, such as induced hypothermia (cooling), which is designed to protect endangered cells, prevent tissue death and preserve organ function following acute events associated with severe oxygen deprivation such as stroke or cardiac arrest. Therapeutic hypothermia is believed to work by protecting critical tissues and organs (such as the brain, heart and kidneys) following ischemic or inflammatory events, by lowering metabolism and preserving cellular energy stores, thereby potentially stabilizing cellular structure and preventing or reducing injuries at the cellular, tissue and organ level. Two international clinical trials on hypothermia after cardiac arrest published in The New England Journal of Medicine demonstrated that induced hypothermia reduced mortality and improved long-term neurological function. Based on these and other results, the American Heart Association (AHA) and the International Liaison Committee on Resuscitation (ILCOR) have issued guidelines recommending that cardiac arrest victims be treated with induced hypothermia.
Ischemic diseases constitute the largest segment of the medical market in the United States and in almost all developed countries worldwide. For example, in the U.S. and other developed countries, an estimated 1.4 million people experience cardiac arrest each year, of which an increasing number (currently about 350,000) survive to receive advanced care. The AHA guidelines now recommend the use of therapeutic cooling as part of the critical care procedures for patients with an out-of-hospital cardiac arrest following ventricular fibrillation. With respect to heart attacks, an estimated 325,000 people in the U.S., and approximately 375,000 people outside the U.S., receive emergency angioplasty or anti-clotting treatment as first-line care.
InnerCool's RapidBlue(TM) and CoolBlue(TM) Temperature Modulation Systems
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 degree 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 degree 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 include endovascular cooling for cardiac arrest (resuscitation), acute ischemic stroke, myocardial infarction (heart attack) and trauma.
InnerCool's CoolBlue(TM) 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 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.
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 http://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 http://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 http://www.cardiumthx.com or view its 2007 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 2008 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)
|SOURCE Cardium Therapeutics|
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