MOUNTAIN VIEW, Calif., Sept. 7, 2011 — Jan Medical (www.janmedical.com) announced today that the first patients have been enrolled in a clinical study at the University of California, San Francisco (UCSF) of the Company’s portable, continuous brain-sensing system for detecting cerebral vasospasm. The study is being led by Wade S. Smith, M.D., Ph.D., Director, UCSF Neuroscience ICU, Professor of Neurology, University of California, San Francisco.
The study is expected to be completed this fall with enrollment of up to 70 patients who have survived a subarachnoid hemorrhage stroke (SAH). The study will validate the Nautilus NeuroWaveTM system’s ability to detect vasospasms in this patient cohort.
Vasospasm refers to a condition in which blood vessels spasm, leading to vasoconstriction and often to ischemia and irreversible brain damage. Cerebral vasospasms usually arise in the context of subarachnoid hemorrhage (SAH) from a ruptured cerebral aneurysm. Vasospasm typically materializes 4 to 10 days after SAH. The essential problem with vasospasm is that it causes an artery to reduce or completely shut down blood flow. Since a brain artery's function is to transport blood to a specific part of the brain, it follows that vasospasm leads to loss of the ability of the artery to carry out its normal function.
“What is needed is a safe, noninvasive, user-independent method to detect cerebral vasospasm before it causes brain injury,” said Dr. Smith. “The technology needs to be simple, and portable, to be most effective in the Neuro Critical Care setting. Such a tool will likely improve patient outcomes by more immediately detecting vasospasm so we can aggressively prevent stroke with cerebral angioplasty and/or vasospressor therapy. Such a technology holds the promise to directly help patients and shorten the length of stay within the Neuro ICU.”
“Our Nautilus NeuroWaveTM system can rapidly provide critical information on a patient presenting with stroke symptoms, and it can also be used as a continuous monitor of changes to the cerebral vasculature. It is this latter ability, continuous monitoring, that provides a unique capability in detecting the onset of vasospasms,” added Paul Lovoi, Ph.D., CEO of Jan Medical. “We are hopeful that this study will confirm our portable and continuous brain-sensing system’s ability to detect vasospasms quickly and noninvasively”.”
Cerebral vasospasm detection is the second clinical application studied for the Jan Medical Nautilus NeuroWave system. The initial application studied was the rapid determination of ischemic stroke, and was disclosed earlier this year during the annual scientific meeting of the Society of Interventional Radiology (SIR) by Dr. Kieran Murphy, Vice Chair & Deputy Chief of Medical Imaging and Director of Medical Imaging Research at the University of Toronto. Dr. Murphy’s clinical study concluded that “the Jan Medical (portable brain sensing) system represents a new paradigm for detecting, diagnosing and monitoring stroke. The small size, portability and processing speed might, one day, allow for the differential diagnosis of stroke victims in minutes, which in turn could allow for stroke triage outside of a hospital setting, thus further reducing the time to initial treatment and dramatically improving patient outcomes.”
Jan Medical is a privately held, emerging medical technology company that has developed the world’s first and only portable brain sensing system designed to rapidly diagnose and aid assessment of strokes.