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CARDIUM HIGHLIGHTS/FINANCIAL RESULTS AND 2009 OUTLOOK.


Cardium Therapeutics (NYSE NYSE

See: New York Stock Exchange
 Amex: CXM CXM Canmex Minerals Corporation (stock symbol) ), San Diego, has reported highlights and financial results for its fourth quarter and fiscal year ended December 31, 2008, and other important recent developments and outlook for 2009.

Recent Developments and 2009 Outlook

Cardium's business is focused on the acquisition and strategic development of product opportunities or businesses having the potential to address significant unmet medical needs, and definable pathways to commercialization, partnering or other monetization. As our product opportunities and businesses are advanced and corresponding valuations established, we intend to consider various corporate development transactions designed to place our product candidates into larger organizations or with partners having existing commercialization, sales and marketing resources, and a need for innovative products. Such transactions could involve the sale, partnering or other monetization of particular product opportunities or businesses. In November 2008, Cardium reported that it was focusing principal near-term efforts on its InnerCool Therapies and Tissue Repair subsidiaries - both of which we believe are nearing completion of their strategic development programs initiated in 2006.

InnerCool Therapies completed its high-performance endovascular-based cooling system, RapidBlue(TM), and the system was cleared by the FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
 in late 2008. InnerCool also developed a new class of targeted organ-specific cooling applications, including its UroCool(TM) pelvic cooling catheter system, which is designed to induce localized cooling during surgery for prostate cancer prostate cancer, cancer originating in the prostate gland. Prostate cancer is the leading malignancy in men in the United States and is second only to lung cancer as a cause of cancer death in men. . An application for FDA 510(k) clearance of the UroCool(TM) system was submitted in the first quarter of 2009. Tissue Repair Company successfully advanced its MATRIX Phase 2b clinical study, which is principally designed to evaluate the ability of Excellarate(TM) to promote rapid closure of previously 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, and to gather additional information regarding safety and clinical use. Enrollment in the MATRIX clinical study is expected to be completed and select top line data announced shortly. In keeping with Cardium's business model, we expect to consider strategic partnering or other transactions designed to further advance these products to commercialization.

InnerCool Therapies

InnerCool was acquired by Cardium in 2006. As a result of Cardium's efforts, InnerCool is now uniquely positioned with a portfolio of temperature modulation therapy products and products under development that include endovascular and surface-based systems (for cooling and warming) that are easy to use and address a wide range of care environments, such as emergency vehicles, emergency rooms and intensive care units, and in operating room operating room
n. Abbr. OR
A room equipped for performing surgical operations.
 settings such as in neurology, cardiac and urology surgeries. In addition, through Cardium's investment, InnerCool's product portfolio and pipeline of new and innovative future products are supported by a fully-integrated 29,000 square foot cGMP facility with R&D and manufacturing capabilities. InnerCool is also positioned to benefit from participation in cutting-edge research efforts with the potential to broaden the applicability of patient temperature modulation for advanced therapies.

Consistent with Cardium's business strategy, the Company believes that InnerCool has reached a significant valuation inflection point Inflection Point

An event that changes the way we think and act.
-Andy Grove, Founder of Intel.

Notes:
For example, the fall of the Berlin Wall was an inflection point in global politics and the commercialization of the Internet was an inflection point in technology.
 within Cardium's investment portfolio, and with the appropriate strategic positioning, best-in-class products and a pipeline of innovative product opportunities, Cardium intends to advance InnerCool's therapeutic cooling and warming products into corresponding markets through the strategic sale of the business to a large and diversified medical device company or through various vertical partnering opportunities with established companies having existing sales and marketing organizations but with a continuing need for innovative, high-value content products. The Company believes this strategy is more cost-effective than building InnerCool into a fully integrated manufacturing, sales and marketing organization. Recent highlights and ongoing product development and clinical research activities at InnerCool include the following:

U.S. Food and Drug Administration (FDA) 510(k) clearance to market the RapidBlue(TM) System, an endovascular temperature modulation device. The new RapidBlue System is believed to be the most powerful easy to use endovascular-based system available. InnerCool has obtained CE mark approval and Underwriters Laboratories, Inc. (UL) certification for the new RapidBlue system. The CE mark allows InnerCool to market the Rapid Blue system in Europe and many other countries that recognize the certification. InnerCool's establishment of commercialization agreements with leading distributors of medical products for exclusive marketing, sales and distribution rights in Austria, Germany, Italy, Switzerland, Australia and New Zealand New Zealand (zē`lənd), island country (2005 est. pop. 4,035,000), 104,454 sq mi (270,534 sq km), in the S Pacific Ocean, over 1,000 mi (1,600 km) SE of Australia. The capital is Wellington; the largest city and leading port is Auckland.  for InnerCool's RapidBlue(TM) endovascular system and CoolBlue(TM) surface temperature modulation system. During the year, InnerCool was also awarded a new supplier contract with Novation The substitution of a new contract for an old one. The new agreement extinguishes the rights and obligations that were in effect under the old agreement.

A novation ordinarily arises when a new individual assumes an obligation to pay that was incurred by the original party
, LLC (Logical Link Control) See "LANs" under data link protocol.

LLC - Logical Link Control
, a leading health care contracting company.

InnerCool's development of a new class of targeted organ-specific cooling applications, including UroCool(TM), a pelvic cooling catheter system designed to induce localized cooling during surgery for prostate cancer. Researchers at the University of California The University of California has a combined student body of more than 191,000 students, over 1,340,000 living alumni, and a combined systemwide and campus endowment of just over $7.3 billion (8th largest in the United States). , Irvine believe that therapeutic cooling during prostate surgery (which includes both traditional open surgical approaches and newer robotic-assisted techniques) can reduce tissue damage and inflammation and thereby provide a faster return of bladder control (continence continence /con·ti·nence/ (kon´tin-ens) the ability to control natural impulses.con´tinent

con·ti·nence
n.
1. Self-restraint; moderation.

2.
) and possibly erectile function (potency). The specialized UroCool pelvic cooling catheter is being integrated with InnerCool's current Celsius Control console which has been marketed and sold since 2003 and a regulatory application for FDA 510(k) clearance of the UroCool catheter was submitted in the first quarter of 2009.

Positive clinical findings demonstrating faster recovery of urinary continence using localized manual cooling techniques during robotic-assisted radical prostatectomy Radical prostatectomy
Surgical removal of the entire prostate, a common method of treating prostate cancer.

Mentioned in: Prostate Cancer

radical prostatectomy  
 surgery will be published in the April 2009 issue of Urology and are now available online at http://www.goldjournal.net/article/S0090-4295(08)01953-5/abstract. The Hypothermic Nerve-sparing Radical Prostatectomy: Rationale, Feasibility, and Effect on Early Continence study conducted by Thomas E. Ahlering, M.D., David S. Finley, M.D., and colleagues at the University of California, Irvine, demonstrated that cooling during robotic-assisted radical prostatectomy surgery resulted in a statistically significant improvement in early postoperative continence following surgery. The results reported on 47 patients receiving 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.
 during robotic-assisted laparoscopic Laparoscopic
A minimally-invasive surgical or diagnostic procedure that uses a flexible endoscope (laparoscope) to view and operate on structures in the abdomen.

Mentioned in: Obstetrical Emergencies
 prostatectomy Prostatectomy Definition

Prostatectomy refers to the surgical removal of part of the prostate gland (transurethral resection, a procedure performed to relieve urinary symptoms caused by benign enlargement), or all of the prostate (radical prostatectomy,
 (hRLP) who were compared with a standard robotic-assisted laparoscopic prostatectomy (RLP RLP Rheinland-Pfalz (state in Germany)
RLP Resource Location Protocol (Cisco)
RLP Radio Link Protocol
RLP Remote Line Printer
RLP Revolving Loan Program
RLP Rotatable Log Periodic
) cohort of 666 controls. Pelvic cooling was achieved using cold irrigation irrigation, in agriculture, artificial watering of the land. Although used chiefly in regions with annual rainfall of less than 20 in. (51 cm), it is also used in wetter areas to grow certain crops, e.g., rice.  and an endorectal cooling balloon cycled with 4 degrees Celsius saline. Urinary continence was defined as requiring no urinary pads. The return to continence was faster for the hRLP (hypothermia) group versus the RLP (control) group: median 39 days versus 59 days, respectively (p=0.002).

Sponsorship of a pilot study to evaluate the use of early and rapid cooling in heart attack patients, which is being co-sponsored and conducted by the interventional cardiology center at Lund University Hospital, Sweden. The ongoing clinical study, called RAPID MI-ICE (Rapid Intravascular intravascular /in·tra·vas·cu·lar/ (in?trah-vas´ku-lar) within a vessel.

in·tra·vas·cu·lar
adj.
Within one or more blood vessels.
 Cooling in Myocardial Infarction as Adjunctive to Percutaneous Coronary Intervention Percutaneous coronary intervention (PCI), commonly known as coronary angioplasty or simply angioplasty, is a therapeutic procedure to treat the stenotic (narrowed) coronary arteries of the heart found in coronary heart disease. ), is expected to enroll approximately 20 patients who present within six hours of their heart attack and require angioplasty and stent procedures in order to restore blood flow to the heart. Preclinical and preliminary clinical data suggest that rapid patient cooling using intravenous cold saline in combination with endovascular hypothermia can be initiated without causing delay of reperfusion therapy and may have the potential to enable interventional cardiologists to dramatically reduce heart tissue damage following a heart attack. The Company expects to announce results of the RAPID MI-ICE clinical study in 2009.

Co-sponsorship of the Intravascular Cooling in the Treatment of Stroke - Longer tPA window (ICTuS-L) study, which is a prospective, randomized ran·dom·ize  
tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es
To make random in arrangement, especially in order to control the variables in an experiment.
, controlled, multi-center study, sponsored by the National Institute of Neurological Disorders and Stroke The National Institute of Neurological Disorders and Stroke is a part of the U.S. National Institutes of Health.

The NINDS conducts and supports research on brain and nervous system disorders. Created by the U.S.
 (NINDS NINDS Neurology A multicenter, double blinded, randomized trial–National Institute of Neurological Disorders and Stroke which evaluated the effects of tPA therapy in Pts with stroke. See Thrombolytic therapy, tPA. ). The study is evaluating the safety and feasibility of InnerCool's endovascular temperature modulation therapy as an adjunctive treatment for acute ischemic stroke. The Company expects to announce results of this important safety study in 2009, and is working with investigators to undertake advanced multi-center clinical studies in the U.S. and internationally to evaluate further safety and preliminary efficacy of therapeutic cooling for ischemic stroke patients.

Tissue Repair Company

The Tissue Repair Company (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
) was also acquired by Cardium in 2006. TRC's product candidate, Excellarate(TM), is a DNA-based topical gel designed to be administered once or twice for the potential treatment of non-healing diabetic foot ulcers. This profile would represent a dramatic change from current treatment approaches, which are often not predictably effective and which typically require multiple clinic visits, or in the case of a protein-based treatment, require daily wound cleanings and product applications over an extended period of time. The Company's Phase 2b MATRIX clinical study was initiated in November 2007 and is principally designed to evaluate the ability of Excellarate to promote rapid closure of previously non-healing diabetic foot ulcers and to gather additional information regarding safety and clinical use. Enrollment in the MATRIX clinical study is expected to be completed and select top line data announced shortly.

Consistent with Cardium's business strategy, the Company believes that with the Company's completion of the Phase 2b MATRIX study, the Tissue Repair Company will have reached a key valuation inflection point within Cardium's investment portfolio and in concert with this, Cardium plans to consider potential development and commercialization partnerships for Excellarate with large pharmaceutical companies and companies focused on wound healing. With continued clinical advancement, Excellarate offers the potential to be commercially available in late 2011 or early 2012.

Cardium also plans to explore additional clinical opportunities utilizing TRC's Gene Activated Matrix(TM) (GAM) technology platform. The Company's GAM technology has potential utility in additional indications in which protein therapeutics have had limited success, including the treatment of other dermal dermal /der·mal/ (der´mal) pertaining to the dermis or to the skin.

der·mal or der·mic
adj.
Of or relating to the skin or dermis.
 wounds (e.g., pressure ulcers) and with orthopedic products, including those for repair of damaged hard tissue (e.g., bone) and soft tissue (e.g., ligament, tendon and cartilage). Biologics and Stem Cells for Cardiovascular Disease and Other Indications

Cardium has also developed additional biologics for potential application in cardiovascular disease and other areas of regenerative medicine. Generx(R) (alferminogene tadenovec, Ad5FGF-4) is designed to leverage the body's natural healing processes in response to repeated 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
 stress (insufficient blood flow and myocardial myocardial /myo·car·di·al/ (-kahr´de-al) pertaining to the muscular tissue of the heart.

myocardial

pertaining to the muscular tissue of the heart (the myocardium).
 oxygen supply due to 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).
) - for potential use in treating ischemic conditions such as recurrent angina. Corgentin(TM) (Ad5IGF-1) is designed to enhance myocardial healing in and around the infarct infarct /in·farct/ (in´fahrkt) a localized area of ischemic necrosis produced by occlusion of the arterial supply or the venous drainage of the part.  zone when used as an adjunct to existing vascular-directed pharmacologic and interventional therapies - for potential use in treating acute ischemic injury such as that following a heart attack.

A complementary approach to the development of therapeutics for regenerative medicine involves the use of stem cells that can be incorporated into injured tissue like the heart as a means of preventing further damage and promoting healing of the affected organ. In that regard, filings by Cardium related to Ad5IGF-1 also described the potential use of stem cells, such as mesenchymal stem cells or MSCs transfected with an Ad5IGF-1 vector (such as that used in Corgentin(TM)), for addressing coronary syndromes such as heart disease or heart attack.

With regard to stem cell approaches, recently reported studies conducted by independent researchers at the University of Cincinnati The University of Cincinnati is a coeducational public research university in Cincinnati, Ohio. Ranked as one of America’s top 25 public research universities and in the top 50 of all American research universities,[2]  showed in a preclinical model of heart attack that MSCs that had been transfected with Ad5IGF-1 were particularly effective at promoting 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.
 within the heart and that the zone of heart attack related tissue damage (the infarct zone) was significantly reduced, and cardiac contractile contractile /con·trac·tile/ (kon-trak´til) able to contract in response to a suitable stimulus.

con·trac·tile
adj.
Capable of contracting or causing contraction, as a tissue.
 function significantly improved - further highlighting the potential value of these therapeutic approaches.

Financial Report

For the quarter ended December 31, 2008, the Company reported a net loss of $5 million, or $(0.11) per share, which included research and development costs totaling $2 million and selling, general and administrative expenses of $2.6 million. For the year ended December 31, 2008, Cardium reported net operating losses Net operating losses

Losses that a firm can take advantage of to reduce taxes.
 totaling $24.6 million, or a loss of $(0.55) per share compared to $25.3 million, or $(0.64) per share in 2007. Research and development costs in 2008 were $12.3 million compared to $13.1 million for fiscal year 2007, and selling, general and administrative expenses were $11.6 million in 2008 compared to $12.1 million in 2007. The decrease in research and development costs was primarily due to a reduction in the development costs for InnerCool's RapidBlue system as it has moved from development to production, increased expenses in our efforts to advance our Excellarate product candidate in its Phase 2b clinical trial, offset by reductions in the AWARE Phase 3 clinical trial phase 3 clinical trial Phase 3 study. See Phase study.  costs. Non-cash charges relating to stock-based compensation, depreciation and amortization for the year ended December 31, 2008 totaled $4.0 million compared to $3.5 million in 2007. Total revenue for fourth quarter 2008 was $559,000 compared to $683,000 for fourth quarter 2007. Total revenue for the year ended December 31, 2008 was $2,417,000 compared to $1,587,000 for the previous year, representing a 52% year-over-year increase. The increase in 2008 product revenues was in large part a result of an increase in InnerCool sales resulting from the launch of the CoolBlue surface cooling system in late 2007 and the launch of the RapidBlue in late 2008. Cardium ended the year with cash and cash equivalents totaling $1.1 million compared to $7.7 million the previous year.

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 and related indications. For more informationm, visit http://www.innercool.com.
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Publication:Biotech Financial Reports
Date:May 1, 2009
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