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Temperature modulation therapy to safely and effectively cool patientsrepresents an important new tool that is beginning to be utilized forprotecting the brain from ischemia, especially in post-cardiac arrest patientswho are at higher risk of brain tissue damage due to the prolonged lack ofblood flow. With the increase in survival of cardiac arrest victims resultingfrom the advent of automated external defibrillators, cooling patients is thenext logical therapeutic approach especially in light of the large body ofsupporting scientific literature, and guidelines issued by the American HeartAssociation (AHA) and the International Liaison Committee on Resuscitationrecommending that cardiac arrest victims be treated with induced hypothermia.
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"With the AHA guidelines in effect and increasing national media coverageon temperature modulation therapy, we are finally beginning to see a paradigmshift by physicians and healthcare systems as they increasingly incorporatetherapeutic cooling into the standard practice of medicine. As a result, newlocal community standards of care for cooling cardiac patients are beingestablished across the nation by which hospitals will be judged and heldaccountable by patients, their families, and others if they do not establishcooling programs or fail to apply cooling therapy in accordance with the AHAguidelines," stated Christopher J. Reinhard, Chairman and Chief ExecutiveOfficer of Cardium Therapeutics and InnerCool Therapies.
Reinhard added, "InnerCool is continuing to develop new and innovativebest-of-class medical devices based on our important technology position andexpertise in the growing field of temperature modulation therapy. With ourRapidBlue and CoolBlue systems now completed and FDA-cleared, and the newCoolFuse and UroCool systems in development, this should facilitate theexpansion of use of InnerCool systems for current indications and facilitateongoing research regarding the potential uses of temperature modulation in anumber of different patient populations that could benefit from these newtherapies."
About Patient Temperature Modulation
Patient temperature modulation is a rapidly-advancing field focused onpreserving ischemic tissue and improving patient outcomes following majormedical events such as cardiac arrest, heart attack and stroke, as well as inthe management of patients experiencing trauma or fever. Internal orendovascular temperature modulation is intended to rapidly cool patients fromwithin their bodies in order to reduce cell death and damage caused by acuteischemic events in which blood flow to critical organs such as the heart orbrain is restricted, and to prevent or reduce associated injuries such asadverse neurologic outcomes.
Numerous scientific and medical articles have described the usefulness oftemperature modulation, such as induced hypothermia (cooling), which isdesigned to protect endangered cells, prevent tissue death and preserve organfunction following acute events associated with severe oxygen deprivation suchas stroke or cardiac arrest. Therapeutic hypothermia is believed to work byprotecting critical tissues and organs (such as the brain, heart and kidneys)following ischemic or inflammatory events, by lowering metabolism andpreserving cellular energy stores, thereby potentially stabilizing cellularstructure and preventing or reducing injuries at the cellular, tissue andorgan level. Two international clinical trials on hypothermia after cardiacarrest published in The New England Journal of Medicine demonstrated thatinduced hypothermia reduced mortality and improved long-term neurologicalfunction. Based on these and other results, the American Heart Association(AHA) and the International Liaison Committee on Resuscitation (ILCOR) haveissued guidelines recommending that cardiac arrest victims be treated withinduced hypothermia.
Ischemic diseases constitute the largest segment of the medical market inthe United States and in almost all developed countries worldwide. Forexample, in the U.S. and other developed countries, an estimated 1.4 millionpeople experience cardiac arrest each year, of which an increasing number(currently about 350,000) survive to receive advanced care. The AHAguidelines now recommend the use of therapeutic cooling as part of thecritical care procedures for patients with an out-of-hospital cardiac arrestfollowing ventricular fibrillation. With respect to heart attacks, anestimated 325,000 people in the U.S., and approximately 375,000 people outsidethe U.S., receive emergency angioplasty or anti-clotting treatment asfirst-line care.
InnerCool's RapidBlue(TM) and CoolBlue(TM) Temperature Modulation Systems
InnerCool's RapidBlue system for high-performance endovascular temperaturemodulation includes a programmable console with an enhanced user-friendlyinterface and touch panel screen and powers the low profile flexibleAccutrol(R) catheter to quickly modulate patient temperature at cooling ratesof 4-5 degrees Celsius per hour or warming rates of 2-3 degrees Celsius perhour. The Accutrol catheter, which has a flexible metallic temperature controlelement (TCE(R)) and a built-in temperature feedback sensor to provide fastand precise patient temperature control, can accurately measure core bodytemperature within 0.1 degree Celsius. Its novel software control algorithmprovides automated and precise body temperature control, eliminating the useof peripheral temperature probes which are generally slow in responding tocore temperature changes.
The RapidBlue console and Accutrol catheter can quickly and accuratelymodulate whole body temperature without introducing or exchanging any fluidwithin the body. The system functions by programmably circulating cold orwarm saline in a closed circuit within the catheter to either cool or warm itsouter metallic surface, which effectively conducts heat out of or into thesurrounding bloodstream. The unique design of InnerCool's TCE(R), which isboth thermally conductive and includes alternating surface helices to promotemixing around the TCE, further enhances heat transfer and enables rapidpatient temperature modulation, even in obese patients. The catheter and TCEhave a covalently-bonded heparin coating for hemo-compatibility and thecatheter can be readily inserted intravenously while the patient is in anoperating room or intensive care setting without the need for continuousfluoroscopy. The integrated temperature sensor allows for automatedtemperature management, and also eliminates the need to place bladder or otherpatient temperature probes which can be slow to react to changes in core bodytemperature, and may be uncomfortable to the patient and time-consuming toplace.
Other currently-marketed endovascular systems rely on plastic-basedballoon catheters that are inflated after placement in the bloodstream.Although expansion of the balloons increases their overall surface area forheat transfer, it also tends to make the catheters fairly large and rigid. Inaddition, they do not contain integrated temperature feedback sensors and heattransfer is limited by the very poor conductive nature of plastic. In termsof performance, a medium-sized balloon-based catheter which inflates to about8 mm (24 French) has been reported to cool anesthetized intubated (i.e.surgical) patients at a rate of around 1 degree Celsius per hour. Incomparison, InnerCool's RapidBlue System combines an ultra-thin flexiblemetallic catheter of only 3.5 mm (10.7 French) or 4.6 mm (14 French) with thepotential to achieve cooling rates that are approximately 4-fold faster, i.e.about 1 degree Celsius per 15 minutes. Rapid cooling is considered to beparticularly important for preserving tissue and organ function underconditions of acute ischemia, which result from reduced blood flow to criticaltissues and organs.
The RapidBlue System can be used in inducing, maintaining and reversingmild hypothermia in neurosurgical patients, both in surgery and in recovery orintensive care. The system can also be used for cardiac patients in order toachieve or maintain normal body temperatures during surgery and in recovery /intensive care, and as an adjunctive treatment for fever control in patientswith cerebral infarction and intracerebral hemorrhage. Potential additionalapplications 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, whichincludes a console and a disposable CoolBlue vest with upper thigh pads, isdesigned to provide a complementary tool for use in less acute patients or inclinical settings best suited to prolonged temperature management.InnerCool's CoolBlue vest and thigh pads wrap the body without requiring anyadhesives to stick to the skin and produce cooling rates of around 1 degreeCelsius per hour, i.e. similar to those of currently-marketed surface coolingsystems and endovascular systems using inflatable balloon-based catheters.InnerCool's CoolBlue external or surface-based temperature modulation systemis designed to cool or warm patients from outside of their bodies and isintended for use in less acute settings such as in-hospital fever management.
InnerCool's CoolBlue nurse-friendly and cost-effective surface temperaturemodulation system, launched in the U.S. in fourth quarter 2007, is also nowavailable for sale in Europe and Australia through recently-completeddistributorship agreements.
About Cardium
Cardium Therapeutics, Inc. and its subsidiaries, InnerCool Therapies, Inc.and the Tissue Repair Company, are medical technology companies primarilyfocused on the development, manufacture and sale of innovative therapeuticproducts and devices for cardiovascular, ischemic and related indications.
Cardium's InnerCool Therapies subsidiary is a San Diego-based medicaltechnology company in the emerging field of temperature modulation therapy torapidly and controllably cool the body in order to reduce cell death anddamage following acute ischemic events such as cardiac arrest or stroke, andto potentially lessen or prevent associated injuries such as adverseneurological outcomes. For more information about Cardium's InnerCoolsubsidiary and patient temperature modulation, including InnerCool's newRapidBlue(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 developmentof growth factor therapeutics for the treatment of severe chronic diabeticwounds. TRC's lead product candidate, Excellarate(TM), is a DNA-activatedcollagen gel for topical treatment formulated with an adenovector deliverycarrier encoding human platelet-derived growth factor-BB (PDGF-BB).Excellarate(TM) is initially being developed to be administered once or twicefor the potential treatment of non-healing diabetic foot ulcers. Otherpotential applications for TRC's Gene Activated Matrix(TM) (GAM) technologyinclude therapeutic angiogenesis (cardiovascular ischemia, peripheral arterialdisease) and orthopedic products, including hard tissue (bone) and soft tissue(ligament, tendon, cartilage) repair. For more information about Cardium'sTissue Repair Company subsidiary, please visit http://www.t-r-co.com.
Cardium's Generx product candidate (alferminogene tadenovec, Ad5FGF-4) isa DNA-based growth factor therapeutic being developed for potential use byinterventional cardiologists as a one-time treatment to promote and stimulatethe growth of collateral circulation in the hearts of patients with ischemicconditions such as recurrent angina. For more information about CardiumTherapeutics and its businesses, products and therapeutic candidates, pleasevisit http://www.cardiumthx.com or view its 2007 Annual Report athttp://www.cardiumthx.com/flash/pdf/CardiumAR07_Book_FINAL.pdf.
Forward-Looking Statements
Except for statements of historical fact, the matters discussed in thispress release are forward looking and reflect numerous assumptions and involvea variety of risks and uncertainties, many of which are beyond our control andmay cause actual results to differ materially from stated expectations. Forexample, there can be no assurance that temperature modulation therapies willgain increasing acceptance and use, that alternatives to InnerCool's productswill not be perceived as better, safer or less expensive, that results ortrends observed in one clinical study will be reproduced in subsequentstudies, that necessary regulatory approvals will be obtained, or that our ownactual or proposed products and treatments will prove to be sufficiently safeand effective and will gain market acceptance. Actual results may also differsubstantially from those described in or contemplated by this press releasedue to risks and uncertainties that exist in our operations and businessenvironment, including, without limitation, our limited experience in thedevelopment, testing and marketing of therapeutic hypothermia devices andwhether our efforts to launch new devices and systems will be successful orcompleted within the time frames contemplated, risks and uncertainties thatare 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 oncollaborative relationships and critical personnel, and current and futurecompetition, as well as other risks described from time to time in filings wemake with the Securities and Exchange Commission. We undertake no obligationto release publicly the results of any revisions to these forward-lookingstatements to reflect events or circumstances arising after the date hereof.
Copyright 2008 Cardium Therapeutics, Inc. All rights reserved.
For Terms of Use Privacy Policy, please visit http://www.cardiumthx.com.
Cardium Therapeutics(TM) and Generx(TM) are trademarks of CardiumTherapeutics, 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) andTCE(R) and UroCool(TM) are trademarks of InnerCool Therapies, Inc.(othertrademarks belong to their respective owners)
SOURCE Cardium Therapeutics
