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NEWS RELEASE

June 5, 2003

Media Contact:
   -- UCSD School of Medicine: Sue Pondrom, 619-543-6163

   -- UCSD Jacobs School of Engineering: Denine Hagen, 858-534-2920, dhagen@ucsd.edu

   -- California Institute for Telecommunications and Information Technology: Stephanie Sides, 858-534-5131, ssides@ucsd.edu

UCSD STROKE CENTER RECEIVES MAJOR GRANT TO USE NEW TECHNOLOGIES TO ENHANCE BRAIN-SAVING DIAGNOSIS & TREATMENT

Engineers and Medical Doctors Team to Apply Integrated Wireless and Video Technologies to Provide Long-Distance Consultations

Dr. Brett Meyer, co-director of the UCSD Stroke Center, announces the $5 million, 5-year award and talks about the scope of the SPOTRIAS project. 5:05

Pioneering new techniques that could potentially extend brain-saving stroke treatment to more patients will begin at the University of California, San Diego (UCSD) Stroke Center with a $5 million, 5-year grant from the National Institute of Neurological Diseases and Stroke (NINDS).

Through a collaboration with the UCSD Jacobs School of Engineering and California Institute for Telecommunications and Information Technology [Cal-(IT)²], UCSD Stroke Center physicians will provide remote consultations via wireless and Internet video technology, in an effort to increase the number of stroke patients receiving more timely treatment. The grant, called the Specialized Program of Translational Research in Acute Stroke (SPOTRIAS), will also support the use of a new ultrasound screening tool and clinical trials using hypothermia – cooling of the brain – as a method to extend the window of treatment effectiveness from three to six hours following stroke onset. This technology is being developed by INNERCOOL Therapies, a company co-founded in 1988 by Juan Lasheras, chair of Mechanical and Aerospace Engineering at the Jacobs School and John Dobak, M.D., the company’s president and CEO and an alumnus of the UCSD School of Medicine.

UCSD Stroke Center director Dr. Patrick Lyden and San Diego Emergency Medical Services director Dr. James Dunford comment on the cutting-edge technologies. 1:36

Patrick Lyden, director of the UCSD Stroke Center and principal investigator of SPOTRIAS, notes that time is critical in stroke treatment. Chances of recovery are significantly improved if treatment begins within three hours of stroke onset, but too many strokes result in death or severe disability due to delays in diagnosis and treatment.

Only 30 percent of stroke victims arrive at the hospital in time to be considered as candidates for an effective type of clot-busting therapy called thrombolysis. Of these patients, about 20 percent actually receive the therapy, often because physicians are unsure if the patient is an appropriate candidate for the treatment.

The most effective thrombolytic drug, tissue plasminogen activator (tPA) is used for the treatment of ischemic stroke, which occurs in about 70 to 80 percent of strokes when a blood clot interrupts blood supply to the brain. However, tPA is effective only if given within three hours of stroke onset. And, it is essential to diagnose the precise type of stroke. For example, tPA should not be given if the patient has evidence of bleeding problems, or a hemorrhagic stroke, where bleeding occurs in the brain.

Long-distance consultation
One barrier to timely treatment of stroke patients is a lack of stroke specialists available for immediate diagnosis at many community hospitals.

Dr. Meyer and Ramesh Rao, UCSD Division Director of Cal-(IT)², demonstrate wireless Internet video technology that will permit long-distance, real-time exams of possible stroke victims. 5:22

Internet video technology that allows real-time consultation over long-distances is under development through the collaborative efforts of the UCSD Stroke Center, the UCSD Jacobs School, and Cal-(IT)².

Several community hospitals are expected to participate in a UCSD clinical trial that utilizes this enhanced, broadband wireless Internet technology. When a suspected stroke patient arrives in the emergency room, the local physician will send live video of the patient to a wireless, laptop computer operated by the on-call member of the UCSD stroke team. The UCSD stroke specialist participates in the physical exam as it takes place, consults with the community physician, and advises in administration of appropriate drugs.

This Multi-Media Telemedical Diagnostic System, as this capability is known, brings together expertise and advanced technologies in three distinct areas – video processing, real-time cellular packet-data transport, and medicine – to create a platform for remote diagnosis and treatment of acute medical conditions.The system provides an emergency room or clinic with access to medical specialists by means of a common-place personal laptop computer connected to the Internet via conditioned last-mile access loops and through next-generation QUALCOMM cdma2000 EV-DO cellular data transport technologies.The system combines advanced video compression and synchronization technologies from Path 1 Network Technologies Inc. (OTCBB: PNWK), new technologies to guarantee the quality of service (QoS) for real-time video and medical telemetry over IP networks, and new mobile wireless data communications technologies. The technical goals of this project include improvement of the wireless QoS mechanisms to help ensure the quality of the video feed to the physician.

INNERCOOL Therapies director of marketing Brad Klos demontrates brain-cooling intravascular catheter technology to be used in the trials. 1:30

"We are delighted that this project provided an opportunity to not only piece together state of the art technologies from Cal-(IT)² industry partners, but also to enhance them in a unique way to provide a solution that satisfied the needs of this project,” said Ramesh Rao, UCSD Division Director of Cal-(IT)² and professor of electrical and computer engineering at the Jacobs School. “We are convinced that what we have learned from this experience is more broadly applicable.

Ultrasound diagnosis
To aid in timely stroke diagnosis, UCSD will also investigate the use of contrast-enhanced ultrasound (CE-US) in a 288-patient clinical trial. This non-invasive test is administered at the bedside to measure obstruction in blood vessels. The investigators believe that CE-US will provide physicians with immediate feedback to determine if the patient is an appropriate candidate for thrombolytic therapy.

Brain Cooling
“While these projects will aid early identification of stroke patients, we would also like to extend the window for therapeutic intervention after acute ischemic stroke beyond the current three-hour limit,” Lyden said. “We may be able to obtain the extra time with hypothermia. Cooling the brain could preserve brain cells longer, allowing us to administer thrombolytic therapy up to six hours after stroke onset.”

Noting that surface cooling techniques such as ice water baths and air-cooled blankets cause complications and fail to adequately cool patients, Lyden is utilizing INNERCOOL Therapies’ catheter technology that allows intravascular cooling methods. The catheters reside in the inferior vena cava and exchange heat with the patient’s blood, while pharmacological agents and surface warming blankets lower the patient’s thermoregulatory responses to prevent shivering.

“The projects at UCSD will go a long way to take acute stroke treatment out to more patients. Dr. Patrick Lyden and his UCSD colleagues will find ways to widen the window of opportunity for therapy, extend a helping hand to community hospitals, and improve emergency diagnostic procedures,” said Mary Ellen Michel, Ph.D., NINDS program director for the project.

The UCSD Stroke Center
The projects planned under the SPOTRIAS grant represent the continuing efforts of UCSD Stroke Center physicians and researchers who have played a leading role in the development of new therapies for stroke.

For example, basic research by UCSD neuroscientist Justin Zivin, M.D., Ph.D. pioneered the development of tPA, and continuing investigations by UCSD researchers seek new therapies.

Following the development of tPA in the 1990s, Lyden co-led the National Institutes of Health sponsored clinical trials of the drug. As part of the trial in San Diego, the UCSD Stroke Center brought together other community neurologists to set up the San Diego Stroke Council, which educates both patients and physicians about the warning signs of stroke and the need for urgent evaluation and treatment. Also established was a Stroke Center Network to facilitate transport of acute stroke patients to hospitals with a stroke treatment team that sees the patient within a few minutes of arrival and evaluates the individual for use of tPA.

Last year, the UCSD Stroke Center was recognized by the University HealthSystem Consortium (UHC) as one of the nation’s top academic medical centers providing stroke treatment. In a nationwide survey of 33 academic medical centers and 1,227 patients, the UCSD Stroke Center ranked second overall, measured against a variety of clinical benchmarks, including complication and death rates, length of hospitalization, diagnostic tests, and health counseling prior to discharge.

Recently, the UCSD Stroke Center was selected by NINDS as the site for production of a national DVD to train medical professionals to in the use of the NIH Stroke Scale. Lyden was named lead medical advisor for the NINDS DVD project, which included two weeks of filming in February at UCSD Medical Center in Hillcrest and on the UCSD campus in La Jolla.

In addition to its strong research and clinical components, the UCSD Stroke Center trains the next generation of stroke specialists in a Stroke and Vascular Neurology program that offers two physician fellowships each year.

# # #

Additional information:

NINDS, a division of the National Institutes of Health, at the Department of Health and Human Services, launched the SPOTRIAS program in an effort to develop and offer more rapid diagnosis and clinical treatments to acute stroke patients. UCSD is the third SPOTRIAS program to be funded, joining the University of Texas Medical School at Houston and the University of Cincinnati. NINDS plans to fund a total of 10 SPOTRIAS grants over the next three years.

INNERCOOL
INNERCOOL was co-founded in 1998 by John Dobak, M.D., the company’s president and CEO and an alumnus of the UCSD School of Medicine, and Juan Lasheras, chair of Mechanical and Aerospace Engineering at the UCSD Jacobs School.

The Celsius Control System™ consists of an endovascular catheter, console and proprietary disposables. The distal portion of the catheter incorporates a flexible Temperature Control Element (TCE) that is cooled or warmed with saline solution circulated in a closed-loop manner from the console. When placed in the inferior vena cava, the TCE exchanges thermal energy directly with the blood, resulting in cooling or warming of the downstream organs and body. The Celsius Control System does not infuse fluid into the patient, nor is blood circulated outside of the body.

INNERCOOL received FDA clearance in January 2003 for the Celsius Control System to induce, maintain and reverse mild hypothermia in neurosurgical patients in surgery and recovery/intensive care.

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