SAN DIEGO, Sept. 21 /PRNewswire-FirstCall/ -- InnerCool Therapies, a
subsidiary of Cardium Therapeutics, Inc. (OTC Bulletin Board: CDTP),
announced today that Michael K. Morgan, M.D. reported on his direct
experience and the benefits of the Celsius Control System(TM) in inducing
hypothermia in cerebral vascular surgery patients at the Neurosurgical
Society of Australasia (NSA) Annual Scientific Meeting in Cairns,
Australia. Dr. Morgan is a noted vascular neurosurgeon and Professor and
Dean of the School of Advanced Medicine, Macquarie University, Sydney,
Honorary Professor of Neurosurgery at the University of Sydney, and
Cerebrovascular Neurosurgeon at Dalcross Hospital.
(Logo: http://www.newscom.com/cgi-bin/prnh/20051018/CARDIUMLOGO )
Dr. Morgan outlined the benefits of inducing hypothermia with
InnerCool's catheter-based endovascular Celsius Control System in patients
undergoing aneurysm surgery. In his retrospective review of over 600
aneurysms over a seven-year period, Dr. Morgan found that patients with
aneurysms greater than 12 millimeters are more likely to have over 20
minutes of temporary occlusion times. Temporary occlusion of arteries in
the brain during aneurysm repair in such patients exposes the brain to
ischemia (localized lack of oxygen), which can have negative consequences
in terms of neurologic outcomes. Dr. Morgan discussed the safety, efficient
cooling and beneficial outcomes achieved utilizing InnerCool's Celsius
Control System in an open-label cohort of 26 patients with 33 aneurysms. In
addition to achieving positive outcomes, he found there were no clinically
significant catheter-related complications. Dr. Morgan plans to submit his
findings for publication in a neurosurgical journal.
"Based on my experience and the clinical data reviewed, aneurysms
greater than 12 millimeters frequently require prolonged temporary
occlusion times. The ability of InnerCool's Celsius Control System to
safely and effectively cool patients with aneurysms provides an important
new tool for protecting the brain from ischemic injury, especially in
patients such as these who are at higher risk for tissue damage due to the
prolonged lack of blood flow," stated Dr. Morgan.
"Dr. Morgan's findings further demonstrate the importance of our
therapeutic hypothermia technology, and it is notable that Dr. Morgan's
findings are supported by and extend a wealth of clinical data in critical
care neurosurgical settings demonstrating that hypothermia can be used to
avoid or ameliorate potentially adverse consequences of brain ischemia,"
stated Christopher J. Reinhard, Cardium's Chairman and Chief Executive
Officer.
InnerCool's approach to therapeutic hypothermia is based on a
single-use flexible metallic catheter and a fully-integrated endovascular
cooling system, which allows for rapid and controlled cooling and
re-warming. InnerCool's Celsius Control System integrates a number of
desirable features including a slim catheter profile, a highly efficient
flexible metallic heat transfer element, a built-in temperature monitoring
sensor, and a programmable console capable of rapidly and controllably
inducing, maintaining and reversing therapeutic cooling. InnerCool's
endovascular catheter-based Celsius Control System has received FDA 510(k)
clearance for use in inducing, maintaining and reversing mild hypothermia
in neurosurgical patients, both in surgery and in recovery or intensive
care. The system has also received FDA clearance for use in 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 future applications of the technology include
endovascular cooling for cardiac arrest, acute ischemic stroke and
myocardial infarction (heart attack).
Numerous articles have been published in scientific and medical
journals describing the usefulness of therapeutic cooling, which is
designed to protect endangered cells, prevent tissue death and preserve
organ function following events associated with severe deprivation such as
stroke or cardiac arrest. Therapeutic hypothermia is believed to work by
protecting critical tissues and organs such as the brain, heart and kidneys
following acute ischemic or inflammatory events, by lowering metabolism and
preserving cellular energy stores, thereby potentially stabilizing cellular
structure and preventing or reducing injuries at the cellular, tissue and
organ level. The American Heart Association (AHA) recently revised its
treatment guidelines to recommend the use of therapeutic cooling as part of
the critical care procedures for patients with an out-of-hospital cardiac
arrest following ventricular fibrillation. Studies for additional
indications with InnerCool's system are expected to be conducted in
collaboration with the AHA and with the National Institutes of Health
(NIH).
The Celsius Control System is now being used at a number of innovative
and influential U.S. medical centers, including those at Stanford
University, Cornell, Columbia, the University of Michigan, Harborview
Medical Center, San Francisco General Hospital, the University of
California Medical Centers at San Diego and San Francisco, and at medical
centers in Australia and Sweden.
About Cardium
Cardium Therapeutics, Inc. is a medical technology company primarily
focused on the development, manufacture and sale of innovative therapeutic
products for cardiovascular and related indications. In October 2005,
Cardium acquired a portfolio of growth factor therapeutics from the
Schering AG Group, Germany, including the later-stage product candidate,
Generx(TM), and completed a $30 million financing. Generx (alferminogene
tadenovec) 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 and its businesses, products and therapeutic
candidates, please visit http://www.cardiumthx.com.
In March 2006, Cardium acquired the technologies and products of
InnerCool Therapies, Inc., a San Diego-based medical technology company in
the emerging field of therapeutic hypothermia, which is designed 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 therapeutic hypothermia, including its Celsius Control
System(TM), which has now received regulatory clearance in the U.S., Europe
and Australia, please visit http://www.innercool.com.
In August 2006, Cardium acquired the technologies and products of the
Tissue Repair Company (TRC), 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, is a DNA-activated collagen gel for topical treatment
formulated with an adenovector delivery carrier encoding human
platelet-derived growth factor-B (PDGF-B). Excellarate is initially being
developed as a single administration for the 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), soft tissue (ligament, tendon) and
cartilage. For more information about Cardium's Tissue Repair Company
subsidiary, please visit http://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, our limited experience in the development of
DNA-based cardiovascular therapeutics and therapeutic hypothermia devices,
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 2006 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.
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.
SOURCE , Cardium Therapeutics, Inc.
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Related links:
http://www.innercool.com
http://www.t-r-co.com http://www.cardiumthx.com/
Photo Notes:
NewsCom: http://www.newscom.com/cgi-bin/prnh/20051018/CARDIUMLOGO
AP Archive: http://photoarchive.ap.org
PRN Photo Desk, photodesk@prnewswire.com
CONTACT:
Press / Investors, Bonnie Ortega, Director,
Investor/Public Relations, Cardium Therapeutics, Inc.,
+1-858-436-1018, InvestorRelations@cardiumthx.com
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