First Responders Leading the Charge of Cooling Therapy for Cardiac
Patients SAN DIEGO, Jan. 29 /PRNewswire-FirstCall/ -- Cardium
Therapeutics (NYSE Alternext US: CXM) and its operating unit
InnerCool Therapies today reported on the growing trend of the
country's first responders leading the charge and adopting
therapeutic hypothermia protocols for cardiac arrest patients.
Newly emerging protocols recommend that cardiac arrest patients be
quickly cooled, beginning even before they reach the hospital, and
that they be transported to hospitals with therapeutic cooling
systems in place. Emergency Medical Services (EMS) providers have
implemented therapeutic cooling protocols in a number of major U.S.
cities including Seattle, WA, Boston, MA, Raleigh, NC, Houston, TX,
Phoenix, AZ and New York, NY. As recently reported by the New York
Times, effective January 1, 2009, New York City ambulances are
required to take post-cardiac arrest patients to hospitals that
have adopted therapeutic hypothermia protocols. These changes in
the standard of care follow a growing number of reports regarding
the importance of cooling in the treatment of cardiac patients.
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American Heart Association On December 2, 2008, the American Heart
Association (AHA) reported further on this emerging trend in a
scientific consensus statement entitled "Post Arrest Syndrome.
Epidemiology, Pathophysiology, Treatment, and Prognostication." in
the journal of Circulation. As noted, "Preclinical and clinical
evidence strongly supports mild therapeutic hypothermia as an
effective therapy for the post-cardiac arrest syndrome. Unconscious
adult patients with spontaneous circulation after out-of-hospital
VF cardiac arrest should be cooled to 32 degrees Celsius to 34
degrees Celsius for at least 12 to 24 hours. Most experts currently
recommend cooling for at least 24 hours. Although data support
cooling to 32 degrees Celsius to 34 degrees Celsius, the optimal
temperature has not been determined. Induced hypothermia might also
benefit unconscious adult patients with spontaneous circulation
after out-of-hospital cardiac arrest from a nonshockable rhythm or
in-hospital cardiac arrest. Although the optimal timing of
initiation has not been defined clinically, current consensus is to
initiate cooling as soon as possible." Temperature modulation
therapy to safely and effectively cool patients represents an
important new tool that is beginning to be utilized for protecting
the brain from ischemia, especially in post-cardiac arrest patients
who are at higher risk of brain tissue damage due to the prolonged
lack of blood flow. With the increase in survival of cardiac arrest
victims resulting from the advent of automated external
defibrillators, cooling patients is the next logical therapeutic
approach especially in light of the large body of supporting
scientific literature, and guidelines issued by the AHA and the
International Liaison Committee on Resuscitation recommending that
cardiac arrest victims be treated with induced hypothermia.
Cardiology News and Other Reports Therapeutic hypothermia has been
increasingly in the news and is now beginning to become a standard
of care in a growing number of hospitals and emergency medical
centers. In an article entitled "Cooling for Cardiac Arrest Catches
On" in Cardiology News, Mary Ann Peberdy, Professor of Medicine and
Emergency Medicine at Virginia Commonwealth University in Richmond
summarized these trends, noting that "there has been a major shift
in the use of therapeutic hypothermia. We've seen a substantial
increase in interest so that at the start of 2009 there is
generally at least one large center routinely using therapeutic
hypothermia for cardiac arrest patients in virtually every major
U.S. metropolitan area." In a November 4, 2008 article entitled
"Raising the Dead: Prehospital hypothermia for cardiac arrest
victims may improve neurological outcome and survival to
discharge", authors Mike Clumpner and Jim Mobley, early adopters of
pre-hospital hypothermia therapy for cardiac arrest patients,
commenting on Regional One Air Medical Service in South Carolina's
therapeutic hypothermia protocol implemented in 2005, noted that
"therapeutic hypothermia offers many proven benefits for the
post-cardiac arrest patient if hypothermia is induced within the
first 15 minutes following resuscitation and therapeutic
temperature is achieved within two hours." The authors also noted,
"Because therapeutic hypothermia was researched thoroughly and
fully endorsed by the AHA without specific reference to in-hospital
versus out-of-hospital initiation, we felt it would be beneficial
to adopt the complete resuscitation algorithm at our service. Like
many others, we felt it would be unethical to withhold a proven
treatment from our patients." "We are pleased to see EMS agencies
and others encouraging the paradigm shift in the healthcare system
as they increasingly incorporate therapeutic cooling into their
current standard practices," stated Christopher J. Reinhard,
Chairman and Chief Executive Officer of Cardium Therapeutics and
InnerCool Therapies. "There is a tremendous opportunity in this
market considering that only an estimated 100 out of 24,000 EMS
agencies in the United States have instituted cooling protocols for
post cardiac arrest patients. With InnerCool's new RapidBlue
in-hospital cooling system, and CoolFuse, a pressurized infusion
system being developed for cooling in emergency vehicles and
emergency rooms, InnerCool will be well positioned to provide EMS
agencies around the country with the system they need to initiate
cooling of cardiac arrest patients en route to the hospital, and to
effectively complete and maintain cooling once patients reach the
hospital." RapidBlue(TM) Endovascular Temperature Modulation System
InnerCool's RapidBlue system for high-performance endovascular
temperature modulation includes a programmable console with an
enhanced user-friendly interface and touch panel screen and powers
the low profile flexible Accutrol(R) catheter to quickly modulate
patient temperature at cooling rates of 4-5 degrees Celsius per
hour or warming rates of 2-3 degrees Celsius per hour. The Accutrol
catheter, which has a flexible metallic temperature control element
(TCE(R)) and a built-in temperature feedback sensor to provide fast
and precise patient temperature control, can accurately measure
core body temperature within 0.1 degree Celsius. Its novel software
control algorithm provides automated and precise body temperature
control, eliminating the use of peripheral temperature probes which
are generally slow in responding to core temperature changes. The
RapidBlue console and Accutrol catheter can quickly and accurately
modulate whole body temperature without introducing or exchanging
any fluid within the body. The system functions by programmably
circulating cold or warm saline in a closed circuit within the
catheter to either cool or warm its outer metallic surface, which
effectively conducts heat out of or into the surrounding
bloodstream. The unique design of InnerCool's TCE(R), which is both
thermally conductive and includes alternating surface helices to
promote mixing around the TCE, further enhances heat transfer and
enables rapid patient temperature modulation, even in obese
patients. The catheter and TCE have a covalently-bonded heparin
coating for hemo-compatibility and the catheter can be readily
inserted intravenously while the patient is in an operating room or
intensive care setting without the need for continuous fluoroscopy.
The integrated temperature sensor allows for automated temperature
management, and also eliminates the need to place bladder or other
patient temperature probes which can be slow to react to changes in
core body temperature, and may be uncomfortable to the patient and
time-consuming to place. Other currently-marketed endovascular
systems rely on plastic-based balloon catheters that are inflated
after placement in the bloodstream. Although expansion of the
balloons increases their overall surface area for heat transfer, it
also tends to make the catheters fairly large and rigid. In
addition, they do not contain integrated temperature feedback
sensors and heat transfer is limited by the very poor conductive
nature of plastic. In terms of performance, a medium-sized
balloon-based catheter which inflates to about 8 mm (24 French) has
been reported to cool anesthetized intubated (i.e. surgical)
patients at a rate of around 1 degrees Celsius per hour. In
comparison, InnerCool's RapidBlue System combines an ultra-thin
flexible metallic catheter of only 3.5 mm (10.7 French) or 4.6 mm
(14 French) with the potential to achieve cooling rates that are
approximately 4-fold faster, i.e. about 1 degrees Celsius per 15
minutes. Rapid cooling is considered to be particularly important
for preserving tissue and organ function under conditions of acute
ischemia, which result from reduced blood flow to critical tissues
and organs. The RapidBlue System can be used in inducing,
maintaining and reversing mild hypothermia in neurosurgical
patients, both in surgery and in recovery or intensive care. The
system can also be used for 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 additional applications of the technology may include
endovascular cooling for cardiac arrest (resuscitation), acute
ischemic stroke, myocardial infarction (heart attack) and trauma.
CoolBlue(TM) Surface Temperature Modulation System InnerCool's
CoolBlue surface temperature modulation system, which includes a
console and a disposable CoolBlue vest with upper thigh pads, is
designed to provide a complementary tool for use in less acute
patients or in clinical settings best suited to prolonged
temperature management. InnerCool's CoolBlue vest and thigh pads
wrap the body without requiring any adhesives to stick to the skin
and produce cooling rates of around 1 degrees Celsius per hour,
i.e. similar to those of currently-marketed surface cooling systems
and endovascular systems using inflatable balloon-based catheters.
InnerCool's CoolBlue external or surface-based temperature
modulation system is designed to cool or warm patients from outside
of their bodies and is intended for use in less acute settings such
as in-hospital fever management. InnerCool's CoolBlue
nurse-friendly and cost-effective surface temperature modulation
system, launched in the U.S. in fourth quarter 2007, is also now
available for sale in Europe and Australia through
recently-completed distributorship agreements. UroCool(TM) Pelvic
Catheter System InnerCool's UroCool(TM), a pelvic catheter system
designed to induce localized cooling during robotic-assisted
prostatectomy surgery, is currently under development and being
utilized by Thomas E. Ahlering, M.D., Professor and Vice Chair of
the Department of Urology and his colleague Dr. David S. Finley
M.D. in studies being conducted at the University of California,
Irvine. Previous findings by the researchers using localized manual
cooling techniques during robotic-assisted radical prostatectomy
surgery indicated that cooling resulted in a significantly faster
recovery of urinary continence following surgery. A regulatory
application for FDA 510(k) clearance of InnerCool's UroCool
catheter is expected to be submitted in the first quarter of 2009.
The UroCool(TM) catheter is designed to be placed within the rectal
cavity adjacent to the prostate during surgery and is used in
conjunction with InnerCool's Celsius Control Console which
circulates cold saline in a closed loop within InnerCool's UroCool
catheter to allow for localized cooling. It is believed that
therapeutic cooling of the prostate gland and surrounding areas
during prostate surgery (which includes both traditional open
surgical approaches and the newer robotic-assisted technique)
offers the potential to reduce tissue damage and inflammation and
thereby provide a faster return of bladder control (continence) and
possibly erectile function (potency) following surgery.
CoolFuse(TM) Infusion System InnerCool's new CoolFuse, also in
development, is a pressurized infusion system for cooling and
warming patients en-route to the hospital and in the emergency
room. The CoolFuse will be provided to EMS agencies and hospitals
to rapidly cool post cardiac arrest patients. Researchers have
found that cold saline infusions (3 degrees Celsius) can lower core
body temperature in transport. 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. 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 or stroke, and to
potentially lessen or prevent associated injuries such as adverse
neurological outcomes. For more information about Cardium's
InnerCool subsidiary and patient temperature modulation, including
InnerCool's new RapidBlue(TM) System, which just received FDA
clearance, and its CoolBlue(TM) System, please visit
http://www.innercool.com/. Cardium also has two biologic candidates
in clinical development. Cardium's Tissue Repair Company subsidiary
(TRC) is 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
(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
http://www.t-r-co.com/. Cardium's Generx product candidate
(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 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 http://www.cardiumthx.com/ or
view its most recent Annual Report at
http://www.cardiumthx.com/flash/pdf/CardiumAR07_Book_FINAL.pdf.
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. For example, there can be no assurance that
temperature modulation therapies will gain increasing acceptance
and use, that alternatives to InnerCool's products will not be
perceived as better, safer or less expensive, that results or
trends observed in one clinical study will be reproduced in
subsequent studies, that necessary regulatory approvals will be
obtained, or that our own actual or proposed products and
treatments will prove to be sufficiently safe and effective and
will gain market acceptance. 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 and whether our efforts to launch
new devices and systems will be successful or completed within the
time frames contemplated, risks and uncertainties that are inherent
in the conduct of human clinical trials, including the timing,
costs and outcomes 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 2009 Cardium Therapeutics,
Inc. All rights reserved. For Terms of Use Privacy Policy, please
visit http://www.cardiumthx.com/. Cardium Therapeutics(TM) and
Generx(TM) are trademarks of Cardium Therapeutics, Inc. Tissue
Repair(TM), Gene Activated Matrix(TM), GAM(TM) and Excellarate(TM)
are trademarks of Tissue Repair Company. InnerCool Therapies(R),
InnerCool(R), Celsius Control System(R), RapidBlue(TM),
CoolBlue(TM). Accutrol(R), Temperature Control Element(R) and
TCE(R) and UroCool(TM) are trademarks of InnerCool Therapies, Inc.
(other trademarks belong to their respective owners)
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http://photoarchive.ap.org/ DATASOURCE: Cardium Therapeutics
CONTACT: Press | Investor Contact, Bonnie Ortega, Director,
Investor|Public Relations of Cardium Therapeutics, Inc.,
+1-858-436-1018, Web Site: http://www.cardiumthx.com/
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