TV News Coverage Reports on InnerCool's CoolBlue System Treatment of Cardiac Shock Patient Following Childbirth at Rush Hospital
February 12 2009 - 9:00AM
PR Newswire (US)
SAN DIEGO, Feb. 12 /PRNewswire-FirstCall/ -- Cardium Therapeutics
(NYSE Alternext US: CXM) and its operating unit InnerCool Therapies
today reported that InnerCool's CoolBlue surface temperature
modulation system was highlighted in a television segment that
aired on Chicago's NBC 5 News. The story can be viewed at
nbcchicago.com/health/tips_info/This_is_Your_Brain_on_Ice_Chicago.html.
The segment features a maternity patient who suffered cardiac shock
while delivering her baby at Rush University Medical Center in
Chicago. The baby was saved as a result of physicians performing an
emergency Caesarean section surgery - however the mother was
clinging to life in a coma and was considered likely to be "brain
dead." Over 40 minutes and a series of electric shocks the mother
was resuscitated while she was simultaneously cooled with
InnerCool's CoolBlue surface cooling system. Months later, she
appears fully recovered and with normal neurological function. The
attending physicians, Drs. Richard E. Temes and Omar Lateef,
expressed their belief that hypothermia can improve brain recovery
in post-cardiac patients and should be widely used. Dr. Temes noted
that "hypothermia is perhaps the most powerful neuroprotecting
agent out there." Dr. Richard Bernstein who heads Northwestern's
Therapeutic Cooling Program stated, "80 percent of hospitals that
should be doing this are not. It takes a champion and some pressure
from patient advocacy groups to make it happen." (Logo:
http://www.newscom.com/cgi-bin/prnh/20051018/CARDIUMLOGO) "There
has been increasing interest in patient temperature modulation
therapy as a result of the growing number of hospitals and EMS
providers adopting cooling protocols for out-of-hospital and
in-hospital cardiac arrest patients. This recent news story is yet
another example of how a patient recovered neurological function
following an in-hospital cardiac arrest who was provided an
opportunity to potentially benefit from our cooling technology,"
stated Christopher J. Reinhard, Chairman and Chief Executive
Officer of Cardium Therapeutics and InnerCool Therapies. "We
believe InnerCool is the only company positioned to offer a
comprehensive portfolio of best-in-class endovascular and surface
cooling solutions to the growing number of hospitals and healthcare
providers in this rapidly expanding therapeutic area." 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 1C 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 is also now available for
sale in Europe and Australia through recently-completed
distributorship agreements. 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 degree
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
degree 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. 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(R) 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)
http://www.newscom.com/cgi-bin/prnh/20051018/CARDIUMLOGO
http://photoarchive.ap.org/ DATASOURCE: Cardium Therapeutics
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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