Healthcare Industry News: hypothermia
News Release - April 29, 2008
Cardium Reports on Science Channel Series Featuring InnerCool's Endovascular Cooling During Brain Surgery at Stanford UniversitySAN DIEGO, April 29 (HSMN NewsFeed) -- Cardium Therapeutics (Amex: CXM ) and its operating unit InnerCool Therapies announced today that InnerCool's endovascular Celsius Control System was featured on Science Channel's "Cool Stuff: How It Works." The segment (episode 5) aired April 25, 2008, and is scheduled to be rebroadcast at 8:30 p.m. and 11:30 p.m. (ET/PT) on May 9, 2008. Please visit http://science.discovery.com/tv-schedules/series.html for broadcast dates and times in your area.
The episode featured InnerCool's Celsius Control(TM) endovascular system during a 6-hour brain surgery at Stanford University School of Medicine in Palo Alto, California, during which Dr. Gary K. Steinberg and his surgical team cooled a patient with InnerCool's endovascular temperature modulation system.
"InnerCool's endovascular systems are well designed to meet the high performance needs of the operating room. We are pleased that our Celsius Control System was profiled on Science Channel's 'Cool Stuff' series highlighting the importance of our endovascular temperature modulation system in neurologic surgeries. We believe our low-profile, high-performance endovascular cooling system has the capacity to rapidly achieve and maintain cooling of patients undergoing these critical brain surgeries, such as the one performed in the segment," stated Christopher J. Reinhard, Chairman and Chief Executive Officer of Cardium Therapeutics and InnerCool Therapies.
"Although the precise mechanism of mild cooling's protective effect on the brain is unclear, it appears to blunt the detrimental cascade of events at the cellular level that occurs during the minutes, hours, and sometimes even days after an adverse neurologic event," stated Dr. Steinberg, Lacroute-Hearst Professor and Chairman of the Department of Neurosurgery at Stanford. "hypothermia therapy is increasingly being used for neuroprotection during neurovascular surgery to improve neurologic function and decrease disability." Dr. Steinberg has been using therapeutic hypothermia in the clinic since 1991 and since that time has used it in more than 2,500 patients with cerebrovascular problems intended to minimize the high risk of stroke and ischemic brain damage.
Patient temperature modulation is a rapidly-advancing field focused on preserving ischemic tissue and improving patient outcomes following major medical events such as stroke, cardiac arrest and heart attack, as well as in the management of patients experiencing trauma or fever. Temperature modulation is intended to cool patients in order to reduce cell death and damage caused by 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.
InnerCool's Patient Temperature Modulation Systems
InnerCool's endovascular approach to patient temperature modulation is based on a single-use flexible metallic catheter and a fully-integrated cooling system, which allows for rapid and controlled cooling and re-warming. InnerCool's endovascular system integrates a number of desirable features including a slim catheter profile, a highly efficient flexible metallic thermal transfer element, a built-in temperature monitoring sensor, and a programmable console capable of rapidly and controllably inducing, maintaining and reversing therapeutic cooling. The Celsius Control System powers InnerCool's Accutrol(TM) catheter, which has a flexible metallic temperature control element and a built-in temperature feedback sensor to provide fast and precise patient temperature control. The Celsius Control System has received FDA 510(k) clearance for use in inducing, maintaining and reversing mild hypothermia in neurosurgical patients, both in surgery and in recovery or intensive care. The system has also received FDA clearance for use in 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, acute ischemic stroke and myocardial infarction (heart attack).
InnerCool's next-generation RapidBlue(TM) system for high-performance endovascular temperature modulation is expected to receive FDA clearance in the second quarter 2008, and to initially have the same clearance as the Celsius Control System. The RapidBlue system includes a programmable console with an enhanced user interface and a catheter designed to quickly modulate patient temperature in association with surgery or other medical procedures. The RapidBlue system powers InnerCool's Accutrol(TM) catheter, which has a flexible metallic temperature control element and a built-in temperature feedback sensor to provide fast and precise patient temperature control.
InnerCool's CoolBlue surface temperature modulation system, which includes a console and a disposable CoolBlue(TM) 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.
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 lead product candidate, Generx(TM) (alferminogene tadenovec, Ad5FGF4), 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 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.
Cardium's InnerCool Therapies subsidiary is a San Diego-based medical technology company in the emerging field of patient 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 Celsius Control System(TM), which has received regulatory clearance in the U.S., Europe and Australia, please visit http://www.innercool.com.
Cardium's Tissue Repair Company subsidiary (TRC) is a San Diego-based biopharmaceutical company 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 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(TM)) 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.
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 commercialization efforts will effectively accelerate InnerCool's patient temperature modulation business, that product modifications or launches will be successful or that the resulting products will be favorably received in the marketplace, that our products or proposed products will prove to be sufficiently safe and effective, that our products or product candidates will not be unfavorably compared to competitive products that may be regarded as safer, more effective, easier to use or less expensive, that results or trends observed in one clinical study or procedure will be reproduced in subsequent studies or procedures, that third parties on whom we depend will behave as anticipated, or that necessary regulatory approvals will be obtained. 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.
Cardium Therapeutics(TM) and Generx(TM) are trademarks of Cardium Therapeutics, Inc.
Gene Activated Matrix(TM), GAM(TM) and Excellarate(TM) are trademarks of Tissue Repair Company.
InnerCool TherapiesŪ, InnerCoolŪ, Celsius Control System(TM), RapidBlue(TM), CoolBlue(TM) and Accutrol(TM) are trademarks of InnerCool Therapies, Inc.
Source: Cardium Therapeutics
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