Healthcare Industry News: hypothermia
News Release - March 9, 2006
Cardium Acquires InnerCool Therapies, a Leading Provider of FDA-Cleared Therapeutic Hypothermia SystemsSAN DIEGO, March 9 (HSMN NewsFeed) -- Cardium Therapeutics, Inc. (OTC Bulletin Board: CDTP ) today announced the acquisition of InnerCool Therapies, Inc., a San Diego-based medical technology company focused on the emerging field of therapeutic hypothermia. InnerCool develops, manufactures and markets endovascular, catheter-based therapeutic systems designed to rapidly and controllably cool the body. InnerCool's Celsius Control System(TM) is currently being used in surgical and intensive care hospital units.
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. InnerCool has also received a CE mark allowing the Celsius Control System to be marketed in the European Community, and a TGA approval allowing the system to be marketed in Australia.
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).
Under the terms of the transaction, which is structured as an asset purchase, Cardium will issue to InnerCool 2.5 million shares of Cardium common stock (which represents less than 8% of the company's outstanding shares after giving effect to the acquisition) and will assume certain outstanding liabilities (totaling approximately five hundred sixty thousand dollars plus transaction costs and vacation accrual). InnerCool investors would also be entitled to a one-time product success payment of $5 million upon full calendar year revenues from the commercial sale of InnerCool products exceeding $20 million. The contingent payment based on product sales would be payable in cash or Cardium common stock at Cardium's election. Cardium will operate the acquired business through its newly-formed wholly-owned Delaware subsidiary, InnerCool Therapies, Inc.
InnerCool's approach to therapeutic hypothermia is based on a single-use 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 metal-based heat transfer element, a built-in temperature monitoring sensor, and a programmable console capable of rapidly and controllably inducing, maintaining and reversing therapeutic cooling. 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.
InnerCool's hypothermia systems are now being introduced at a number of innovative and influential U.S. medical centers, including those at Stanford University, Cornell, Columbia, the University of Michigan, Seattle's Harborview and Swedish medical centers, San Francisco General Hospital, and the University of California medical centers at San Diego and at San Francisco.
"Furthering Cardium's business strategy of developing important new products for the treatment of cardiovascular disease, our InnerCool acquisition brings a cutting-edge medical device business to complement and leverage our biologics approach to treating heart disease," reported Christopher J. Reinhard, Chairman and Chief Executive Officer of Cardium Therapeutics. "Cardium's focus and depth of experience in developing product candidates for cardiovascular disease, as well as its position as a public company, provide us with a dynamic opportunity to acquire selected products and product candidates and advance them to appropriate value-enhancing or partnering opportunities."
Reinhard added that, "Our initial acquisition of cardiovascular growth factor therapeutics from the Schering AG Group, Germany was completed during the fourth quarter of last year, and our acquisition of InnerCool Therapies now represents an important additional step forward. Over $250 million has been invested to develop the products and technologies that we have acquired and now control, and we expect to leverage those investments through additional collaborative studies such as those involving the AHA and the NIH. We will also continue to seek other cost-effective acquisitions intended to accelerate our growth and development as a means to building long-term stockholder value. As we develop our business, we expect to focus on products having the potential to generate sustained revenue while we simultaneously acquire and develop innovative, high potential pharmacologic and medical device opportunities that address large unmet clinical needs."
In connection with the transaction, which involves the acquisition of substantially all of the assets of privately-held InnerCool Therapies, Inc. (a California corporation), Cardium Therapeutics is expected to file a post- effective amendment to its resale registration statement on Form SB-2 to reflect the acquisition transaction as well as the assets acquired from InnerCool. The selling stockholders named in the resale registration statement may not resell any shares pursuant to that registration statement until the post-effective amendment is declared effective by the Securities and Exchange Commission.
InnerCool Therapies is a medical technology company that develops and manufactures disposable catheter systems based on its endovascular hypothermia technology, which is centered around InnerCool's Celsius Control System(TM). The Celsius Control System provides physicians with an endovascular technology that can rapidly and controllably lower patient body temperature, and precisely maintain a chosen target temperature for a desired period of time before allowing the patient to return to normothermic levels. The Celsius Control System consists of a specialized endovascular cooling catheter, fluid circuit disposables and an operational console. The distal portion of the catheter incorporates a flexible metallic heat-exchange region (called the Temperature Control Element(TM) or TCE(TM)), which can be cooled or warmed with saline solution circulated in a closed-loop manner from the console. When placed in the inferior vena cava, the TCE exchanges thermal energy with the blood, resulting in cooling or warming of the downstream organs and body. The Celsius Control System is particularly advantageous in that it can cool the body rapidly and controllably, yet does not infuse fluid into the patient, nor is blood circulated outside of the body. InnerCool recently launched its new Accutrol Catheter(TM), which integrates a temperature sensing probe directly into the catheter, avoiding the need for placing separate temperature probes which can be slow to respond and cumbersome to use, and may not reflect true core body temperature. Potential future applications of the technology include endovascular cooling for cardiac arrest, acute ischemic stroke and myocardial infarction (heart attack). InnerCool operates an approximately 17,000 square foot, FDA-registered and ISO-certified manufacturing facility located in San Diego, California. For additional information about InnerCool Therapies, please visit http://www.innercool.com.
Cardium Therapeutics, Inc., founded in 2003 and headquartered in San Diego, is a medical technology company primarily focused on the development, manufacture and sale of new and innovative therapeutic products for the interventional cardiology market. In October 2005, Cardium acquired a portfolio of cardiovascular growth factor therapeutics from the Schering AG Group, Germany, including the later-stage product candidate, Generx(TM), and completed a $30 million financing. Generx is a DNA-based, myocardial-derived 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 heart of patients with angina pectoris. As reported in this press release, in March 2006 Cardium acquired 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 severe ischemic events such as cardiac arrest or stroke, and to potentially lessen or prevent downstream injuries such as adverse neurologic outcomes. For more information about Cardium and its product candidates, please visit http://www.cardiumthx.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 therapeutic hypothermia will become accepted as standard medical practice for preventing or reducing injuries associated with ischemic events such as cardiac arrest or stroke, that the AHA, NIH or other clinical study sponsors will perform additional hypothermia studies or perform them successfully, that InnerCool's or its collaborators' efforts to secure or expand the therapeutic usefulness of endovascular-based temperature control systems such as the Celsius Control System will be successful, that revenues from our InnerCool products will meet expectations, that other approaches to therapeutic hypothermia will not prove to be more efficient or better protected, that clinical trials and other efforts to accelerate the development of our Generx(TM) product candidate will be successful, that necessary regulatory approvals will be obtained, that our actual or proposed products and treatments will prove to be safe or effective, that third parties on whom we depend will perform as anticipated, that our products or product candidates will lead to value enhancing or partnering opportunities, or that we will succeed in enhancing long-term shareholder value. 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.
Source: Cardium Therapeutics
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