Cardium's InnerCool Announces Launch of New Enhanced Website
27 Januar 2009 - 6:59PM
PR Newswire (US)
SAN DIEGO, Jan. 27 /PRNewswire-FirstCall/ -- Cardium Therapeutics
(NYSE Alternext US: CXM) and its operating unit InnerCool Therapies
today announced the launch of InnerCool's newly redesigned website
at http://www.innercool.com/. The updated and expanded website
highlights InnerCool's new RapidBlue(TM) high-performance
endovascular temperature modulation system, its CoolBlue(TM)
surface system, and CoolConnect Adapters to allow CoolBlue surface
pads to be used with other hypothermia consoles. (Logo:
http://www.newscom.com/cgi-bin/prnh/20051018/CARDIUMLOGO) "The new
website provides enhanced visual content and a more comprehensive
overview of InnerCool's new products. InnerCool is believed to be
the only Company in the U.S. and internationally focused on the
development of a diverse portfolio of best-in-class temperature
modulation therapy products for multiple vertical market
opportunities. We have endovascular and surface-based systems, and
advanced low-profile, flexible catheters with fully integrated
temperature sensors, all of which have FDA 510(k) clearances and CE
marks. In addition, in November 2008, we announced the UroCool
System, an investigational targeted tissue cooling system that has
initially been developed for robotic-assisted and traditional
prostate surgeries. This pelvic cooling technology platform has the
opportunity to be further expanded into other clinical
applications. At the same time, we are working on our CoolFuse
System for use in the hospital setting and by emergency medical
services (EMS)," stated Christopher J. Reinhard, Chairman and Chief
Executive Officer of Cardium Therapeutics and InnerCool Therapies.
RapidBlue(TM) Endovascular Temperature Modulation System The
RapidBlue System 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 intubated, paralyzed patients at a rate of
around 1 degree Celsius per hour. Patients who are intubated and
paralyzed or under general anesthesia are the least difficult to
cool as they cannot respond to physiological changes in body
temperature through shivering. 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 in similar patients. 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 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 degree 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 nurse-friendly and cost-effective CoolBlue
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(TM), also in development, is a pressurized
infusion system for cooling and warming patients en route to the
hospital in an emergency vehicle, as well as in the hospital
setting to start the induction of hypothermia prior to
implementation of endovascular or surface cooling. CoolFuse will be
marketed to EMS agencies and hospitals, which are increasingly
implementing cooling protocols for post cardiac arrest patients in
accordance with guidelines of the American Heart Association and
other agencies involved in resuscitation. 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 last 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)
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.innercool.com/
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