Healthcare Industry News: patient temperature modulation
News Release - December 15, 2008
Cardium's InnerCool Awarded U.S. Supplier Agreement With Novation LLCSAN DIEGO, Dec. 15 (Healthcare Sales & Marketing Network) -- Cardium Therapeutics (NYSE Alternext US: CXM) announced that its operating unit InnerCool Therapies, Inc. was awarded a new supplier contract with Novation LLC to introduce InnerCool's RapidBlue endovascular patient temperature modulation system into Novation's extensive network of member health care systems, which includes thousands of hospitals throughout the United States. The agreement, effective January 1, 2009, has a three-year initial term and includes an option to extend for two additional years.
InnerCool's RapidBlue System is a thermal regulating system designed to manage and control patient body temperature. This system automatically cools or warms patients, as necessary, to quickly and controllably achieve and then maintain a desired body temperature. RapidBlue provides rapid or gradual temperature control for all patient sizes. Its closed loop catheter-based system modulates whole body temperature, without fluid introduction or exchange, by circulating cool or warm saline within the interior of the catheter. Unlike various other systems, RapidBlue is powerful enough to quickly cool awake patients of any size and can eliminate the need to use paralytic agents. The system combines a high-performance programmable console with an enhanced user-friendly interface.
"Novation has built a reputation of supplying its alliance members with exceptional quality and value. With 2,500 members of VHA, Inc. and the University HealthSystem Consortium, and nearly 13,000 members of Provista, LLC, Novation provides the most extensive range of advanced contracting services in the industry," stated Cathy Denning, Senior Director - Surgical Contracting of Novation LLC. "We look forward to working with InnerCool Therapies so that its leading-edge RapidBlue endovascular temperature modulation system is more widely accessible to patients."
"We are pleased to partner with Novation, the nation's leading group purchasing organization. The award of this key supplier contract marks another important milestone in the growing market acceptance of our patient temperature modulation solutions," stated Christopher J. Reinhard, Chairman and Chief Executive Officer of Cardium Therapeutics and InnerCool Therapies.
About InnerCool's RapidBlue(TM) Temperature Modulation System
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®, 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.
About Novation LLC
Founded in 1998, Novation is the leading health care contracting services company for more than 2,500 members of VHA Inc. and the University HealthSystem Consortium (UHC), two national health care alliances and nearly 13,000 members of Provista, LLC. Novation offers its customers contract development and management, supply chain data and measurement, and industry knowledge and advocacy. Based in Irving, Texas, Novation develops and manages competitive contracts with more than 500 suppliers. VHA, UHC and Provista members used Novation contracts to purchase more than $33.1 billion in 2007. For more information on Novation, visit www.novationco.com.
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 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 the contract supplier agreement will effectively accelerate InnerCool's patient temperature modulation business or market, 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®, InnerCool®, Celsius Control System®, RapidBlue(TM), CoolBlue(TM). Accutrol®, Temperature Control Element® and TCE® and UroCool(TM) are trademarks of InnerCool Therapies, Inc. (other trademarks belong to their respective owners)
Source: Cardium Therapeutics
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