March 20, 2007
InnerCool’s Temperature Modulation Therapy Featured in Men’s Health Magazine
Cardium Therapeutics (OTCBB:CDTP) and its subsidiary InnerCool Therapies announced today that its endovascular temperature modulation technology was featured in the March 2007 issue of Men's Health. The article "The Miracle on Ice" highlights the benefits of InnerCool's Celsius Control System during a cranial bypass surgery performed at Stanford University Medical Center. A copy of the article can be accessed at http://www.nxtbook.com/nxtbooks/rms/menh_1-19934755/.
A reporter for Men's Health, Mikel Jollett, follows Gary K. Steinberg, M.D., Ph.D., Chairman of Neurosurgery at Stanford University Medical Center, while he performs an intracranial bypass surgery. The patient is cooled to 33 degrees Celsius, or 91.4 degrees Fahrenheit, with InnerCool's Celsius Control system providing Dr. Steinberg with the valuable time necessary to bypass the blockages in the brain without causing brain-cell death. The patient's underlying condition is Moyamoya disease, a progressive cerebrovascular disorder caused by blocked arteries at the base of the brain. The article states, "Without this decrease in body temperature, the patient's brain would begin suffering a stroke in about 5 minutes. Hypothermia extends the window to 30 to 40 minutes, buying Dr. Steinberg enough time to correct the underlying problem.""The unique ability of our endovascular cooling system to safely and effectively cool patients undergoing neurosurgery provides an important new tool for protecting the brain from ischemia, especially in patients such as these who are at higher risk for tissue damage due to the prolonged lack of blood flow," stated Christopher J. Reinhard, Chairman and Chief Executive Officer of Cardium Therapeutics and InnerCool Therapies.
Patient Temperature Modulation Therapy
Numerous scientific and medical articles have described the usefulness of temperature modulation therapy, 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. Cardium and InnerCool recently announced positive preclinical effects of hypothermia following heart attack and announced a clinical study being conducted by a leading cardiology center in Sweden. Additional clinical studies designed to confirm the benefits of hypothermia in heart attack patients are also being conducted by other groups in the U.S.
In the area of stroke, approximately 700,000 Americans experience a stroke each year, and a comparable number of patients are affected outside the U.S. Although tissue plasminogen activator (tPA) has been shown to lessen damage associated by stroke, particularly if it can be administered within three hours of onset, many stroke patients continue to suffer advanced neurologic damage even though they have received tPA. More importantly, most stroke victims do not arrive at the hospital in time to be candidates for tPA. The American Stroke Association (ASA) has now identified the use of therapeutic hypothermia as a promising area of research for the potential treatment of stroke victims, and it is the subject of ongoing clinical studies being supported by InnerCool Therapies and sponsored by the U.S. National Institutes of Health.
InnerCool's current endovascular, catheter-based temperature modulation system is being used to induce, maintain and reverse hypothermia in neurosurgical patients, both in surgery and in recovery or intensive care; and 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.
Last month InnerCool announced plans to launch two next-generation medical device systems designed to provide innovative and comprehensive solutions for patient temperature modulation. InnerCool's new internal temperature modulation system, which will include an enhanced console and disposable catheter, is designed to also enable rapid re-warming of patients following surgery or other medical procedures, and for the potential warming of trauma and other appropriate patients. InnerCool's new external temperature modulation system, which will include a console and disposable pads, will provide a complementary tool for use in less-acute patients and in clinical settings that do not require very rapid cooling or re-warming, or which are best suited to prolonged temperature management.
For fever control, external cooling devices are becoming one of several important therapies to help manage patients who experience fevers in association with severe neurologic injuries or other medical conditions. The ASA and the American Association of Neurological Surgeons (AANS), as well as other organizations internationally, now recommend proactive fever reduction following neurological injury. The company estimates that more than 450,000 hospital patients in the U.S. experience neurologic or non-neurologic fever conditions that either require or could benefit from proactive therapies to reduce patients' body temperatures. Fever patients typically require treatment for multiple days, sometimes as long as a week.
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. In October 2005, Cardium acquired a portfolio of growth factor therapeutics from the Schering AG Group, Germany, including the later-stage product candidate, Generx™, a DNA-based growth factor therapeutic which is advancing to a Phase 3 clinical study and is 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 brochure at http://www.cardiumthx.com/flash/pdf/CardiumTHX_Brochure.pdf.
In March 2006, Cardium acquired the technologies and products of InnerCool Therapies, Inc., a San Diego-based medical technology company in the emerging field of temperature modulation, which is designed 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 therapeutic hypothermia, including its Celsius Control System™, which has now received regulatory clearance in the U.S., Europe and Australia, please visit www.innercool.com.
In August 2006, Cardium acquired the technologies and products of the Tissue Repair Company (TRC), 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, ExcellarateTM, is a DNA-activated collagen gel for topical treatment formulated with an adenovector delivery carrier encoding human platelet-derived growth factor-B (PDGF-B). 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™ (GAM) technology include therapeutic angiogenesis (cardiovascular ischemia, peripheral arterial disease) and orthopedic products, including hard tissue (bone) and soft tissue (ligament, tendon, cartilage). For more information about Cardium's Tissue Repair Company subsidiary, please visit 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 the results of the surgical procedure described above will be similar to the results achieved in other surgical procedures. 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, risks and uncertainties that are inherent in the conduct of human clinical trials, including the timing and costs 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 2007 Cardium Therapeutics, Inc. All rights reserved.
Cardium Therapeutics™ and Generx™ are trademarks of Cardium Therapeutics, Inc.
Excellarate™, Gene Activated Matrix™ and GAM™ are trademarks of Tissue Repair Company.
InnerCool TherapiesÃ®, InnerCoolÃ® and Celsius Control System™ are trademarks of InnerCool Therapies, Inc.