Healthcare Industry News: Diabetic Foot Ulcer
News Release - September 21, 2006
Dr. Michael Morgan Reports on Benefits of InnerCool's Celsius Control System in Inducing Hypothermia During Aneurysm SurgerySAN DIEGO, Sept. 21 (HSMN NewsFeed) -- InnerCool Therapies, a subsidiary of Cardium Therapeutics, Inc. (OTC Bulletin Board: CDTP ), announced today that Michael K. Morgan, M.D. reported on his direct experience and the benefits of the Celsius Control System(TM) in inducing hypothermia in cerebral vascular surgery patients at the Neurosurgical Society of Australasia (NSA) Annual Scientific Meeting in Cairns, Australia. Dr. Morgan is a noted vascular neurosurgeon and Professor and Dean of the School of Advanced Medicine, Macquarie University, Sydney, Honorary Professor of Neurosurgery at the University of Sydney, and Cerebrovascular Neurosurgeon at Dalcross Hospital.
Dr. Morgan outlined the benefits of inducing hypothermia with InnerCool's catheter-based endovascular Celsius Control System in patients undergoing aneurysm surgery. In his retrospective review of over 600 aneurysms over a seven-year period, Dr. Morgan found that patients with aneurysms greater than 12 millimeters are more likely to have over 20 minutes of temporary occlusion times. Temporary occlusion of arteries in the brain during aneurysm repair in such patients exposes the brain to ischemia (localized lack of oxygen), which can have negative consequences in terms of neurologic outcomes. Dr. Morgan discussed the safety, efficient cooling and beneficial outcomes achieved utilizing InnerCool's Celsius Control System in an open-label cohort of 26 patients with 33 aneurysms. In addition to achieving positive outcomes, he found there were no clinically significant catheter-related complications. Dr. Morgan plans to submit his findings for publication in a neurosurgical journal.
"Based on my experience and the clinical data reviewed, aneurysms greater than 12 millimeters frequently require prolonged temporary occlusion times. The ability of InnerCool's Celsius Control System to safely and effectively cool patients with aneurysms provides an important new tool for protecting the brain from ischemic injury, especially in patients such as these who are at higher risk for tissue damage due to the prolonged lack of blood flow," stated Dr. Morgan.
"Dr. Morgan's findings further demonstrate the importance of our therapeutic hypothermia technology, and it is notable that Dr. Morgan's findings are supported by and extend a wealth of clinical data in critical care neurosurgical settings demonstrating that hypothermia can be used to avoid or ameliorate potentially adverse consequences of brain ischemia," stated Christopher J. Reinhard, Cardium's Chairman and Chief Executive Officer.
InnerCool's approach to therapeutic hypothermia is based on a single-use flexible metallic catheter and a fully-integrated endovascular cooling system, which allows for rapid and controlled cooling and re-warming. InnerCool's Celsius Control System integrates a number of desirable features including a slim catheter profile, a highly efficient flexible metallic heat transfer element, a built-in temperature monitoring sensor, and a programmable console capable of rapidly and controllably inducing, maintaining and reversing therapeutic cooling. InnerCool's endovascular catheter-based 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 future applications of the technology include endovascular cooling for cardiac arrest, acute ischemic stroke and myocardial infarction (heart attack).
Numerous articles have been published in scientific and medical journals describing the usefulness of therapeutic cooling, which is designed to protect endangered cells, prevent tissue death and preserve organ function following events associated with severe 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 acute 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. The American Heart Association (AHA) recently revised its treatment guidelines to 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. Studies for additional indications with InnerCool's system are expected to be conducted in collaboration with the AHA and with the National Institutes of Health (NIH).
The Celsius Control System is now being used at a number of innovative and influential U.S. medical centers, including those at Stanford University, Cornell, Columbia, the University of Michigan, Harborview Medical Center, San Francisco General Hospital, the University of California Medical Centers at San Diego and San Francisco, and at medical centers in Australia and Sweden.
Cardium Therapeutics, Inc. is a medical technology company primarily focused on the development, manufacture and sale of innovative therapeutic products for cardiovascular 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(TM), and completed a $30 million financing. Generx (alferminogene tadenovec) 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 www.cardiumthx.com.
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 therapeutic hypothermia, 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(TM), 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, Excellarate, 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 as a single administration for the 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), soft tissue (ligament, tendon) and 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. 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 of DNA-based cardiovascular therapeutics and therapeutic hypothermia devices, 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 2006 Cardium Therapeutics, Inc. All rights reserved.
Cardium Therapeutics(TM) and Generx(TM) are trademarks of Cardium Therapeutics, Inc.
Gene Activated Matrix(TM) and GAM(TM) are trademarks of Tissue Repair Company.
InnerCool TherapiesŪ, InnerCoolŪ and Celsius Control System(TM) are trademarks of InnerCool Therapies, Inc.
Source: Cardium Therapeutics
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