Cardium Reports on First Quarter 2007 Highlights and Financial Results.SAN DIEGO San Diego (săn dēā`gō), city (1990 pop. 1,110,549), seat of San Diego co., S Calif., on San Diego Bay; inc. 1850. San Diego includes the unincorporated communities of La Jolla and Spring Valley. Coronado is across the bay. -- Cardium Therapeutics (OTCBB OTCBB See OTC Bulletin Board (OTCBB). :CDTP CDTP Cold Differential Test Pressure CDTP Computer Technology Documentation Project ) today reported recent highlights and developments, as well as financial results for its first quarter ended March 31, 2007. Highlights and Recent Developments * Qualification of 35 clinical investigator A clinical investigator involved in a clinical trial is responsible for ensuring that an investigation is conducted according to the signed investigator statement, the investigational plan, and applicable regulations; for protecting the rights, safety, and welfare of subjects under sites for the Generx[TM] AWARE trial. The Phase 3 AWARE trial (Angiogenesis angiogenesis /an·gio·gen·e·sis/ (-jen´e-sis) vasculogenesis; development of blood vessels either in the embryo or in the form of neovascularization or revascularization. an·gi·o·gen·e·sis n. in Women with Angina pectoris who are not candidates for Revascularization) will seek to enroll approximately 300 women at up to 50 U.S. sites. Generx[TM] (Ad5FGF-4) is a potential treatment for myocardial ischemia myocardial ischemia, n a loss of oxygen to the heart muscle caused by blockage of the coronary arteries or their branches. myocardial ischemia (insufficient blood flow within the heart muscle) which gives rise to angina associated with coronary heart disease coronary heart disease: see coronary artery disease. coronary heart disease or ischemic heart disease Progressive reduction of blood supply to the heart muscle due to narrowing or blocking of a coronary artery (see atherosclerosis). . * Completion of the Excellarate[TM] MATRIX clinical investigators meeting and presentation of the results of the Excellarate Phase 1/2 clinical trial, and the design of a Phase 2b trial, at the Symposium of Advanced Wound Care. The Company reported that 30 wound care centers attended the investigators meeting and that at least 27 of the centers are expected to be qualified to participate in the MATRIX Phase 2b study. The MATRIX study (GAM501 for the Treatment of Diabetic Ulcers in the Lower Extremities) will seek to enroll approximately 210 patients and is expected to commence in the third quarter 2007. Excellarate[TM] is a DNA-based collagen gel being developed as a potential topical treatment for non-healing diabetic foot diabetic foot A foot with a constellation of pathologic changes affecting the lower extremity in diabetics, often leading to amputation and/or death due to complications; the common initial lesion leading to amputation is a nonhealing skin ulcer, induced by ulcers. * Advancement of InnerCool's new Endovascular and Surface Temperature Modulation Systems, both of which are planned to be launched within the next two quarters. The next-generation Endovascular Cooling System cooling system: see air conditioning; internal-combustion engine; refrigeration. cooling system Apparatus used to keep the temperature of a structure or device from exceeding limits imposed by needs of safety and efficiency. includes an enhanced console and disposable catheter and will replace InnerCool's Celsius Control System, which is now being used in 25 medical centers in the U.S. InnerCool's new Surface Cooling System will include a console and disposable vest and upper thigh pads. * Agreement with Caesarea Medical Electronics Ltd. for the manufacture of an automated infusion system to be used in Cardium's Phase 3 AWARE study to standardize the cardiac catheter-based administration of its Generx[TM] product candidate. The new automated system provides a simpler and more uniform method of administration for clinical investigators and is one of several improvements Cardium has introduced in an effort to optimize the study. Financial Report For the quarter ended March 31, 2007, the Company reported a net loss of $5.8 million, or $0.17 per share, which included research and development costs totaling $3.2 million and selling, general and administrative expenses of $2.5 million. Non-cash charges relating to relating to relate prep → concernant relating to relate prep → bezüglich +gen, mit Bezug auf +acc stock-based compensation, depreciation and amortization for the first quarter of fiscal 2007 totaled $908,000. Total revenue for the first quarter of 2007 was $309,000 and cash and cash equivalents as of March 31, 2007 were $19.8 million. About Cardium 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 Ischemic An inadequate supply of blood to a part of the body, caused by partial or total blockage of an artery. Mentioned in: Antiangiogenic Therapy, Subarachnoid Hemorrhage, Ventricular Fibrillation ischemic and related indications. Cardium's lead product candidate, Generx (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 collateral circulation n. Circulation maintained in small anastomosing vessels when the main artery is obstructed. collateral circulation in the hearts of patients with ischemic conditions such as recurrent angina recurrent angina Cardiology Sharp precordial pain directly related to cardiac ischemia, seen in 3-5% of Pts with CABG, due either to progressive stenosis or occlusion of a CABG or progressive stenosis in an ungrafted artery. See Angina, CABG, Triple-bypass surgery. . For more information about Cardium Therapeutics and its businesses, products and therapeutic candidates, please visit www.cardiumthx.com or view its recent 2006 Annual Report at www.cardiumthx.com/flash/pdf/2006CardiumAnnualReport.pdf. 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 cardiac arrest n. Abbr. CA A sudden cessation of cardiac function, resulting in loss of effective circulation. Cardiac arrest A condition in which the heart stops functioning. 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 hypothermia Abnormally low body temperature, with slowing of physiological activity. It is artificially induced (usually with ice baths) for certain surgical procedures and cancer treatments. , including InnerCool's Celsius Control System[TM], which has received regulatory clearance in the U.S., Europe and Australia, please visit www.innercool.com. Cardium's Tissue Repair Company subsidiary (TRC TRC Noun (in South Africa) Truth and Reconciliation Commission: a commission which encourages people who committed human rights abuses or acts of terror during the apartheid era to reveal the truth about their crimes in return for immunity from prosecution ) 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[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 Therapeutic angiogenesis is an experimental area of treatment of ischemia, the condition which associated with decrease in blood supply to certain body organs, tissue or part. This usually caused by constriction or obstruction of the blood vessels. (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. Forward-Looking Statements 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, risks and uncertainties that are inherent in the development of complex biologics and the conduct of human clinical trials, including the timing, costs and outcomes of such trials, and our ability to obtain necessary regulatory approvals and expected qualifications, our limited experience in the development, testing and marketing of therapeutic hypothermia devices and whether our efforts to accelerate the commercialization of such devices and launch new devices will be successful or completed within the timeframes contemplated, 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. For Terms of Use Terms of Use are rules set up by the owner of an intellectual property or service to govern how they may be legally used. In many cases, terms of service are used as a contractual agreement between a company and users of a service they provide. Privacy Policy, please visit www.cardiumthx.com. 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 Therapies[R], InnerCool[R] and Celsius Control System[TM] are trademarks of InnerCool Therapies, Inc. |
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