Jan Medical announced that the first patients have been enrolled in a clinical study at the University of California, San Francisco, USA, of the company’s portable, Nautilus NeuroWave continuous brain-sensing system for detecting cerebral vasospasm.
The study is being led by Wade S Smith, professor of Neurology and director Neuroscience Intensive Care Unit, University of California. It is expected to be completed this autumn with enrolment of up to 70 patients who have survived a subarachnoid haemorrhage stroke.
“What is needed is a safe, noninvasive, user-independent method to detect cerebral vasospasm before it causes brain injury,” said 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 Intensive Care Unit.”
“Our Nautilus NeuroWave 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, 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 ischaemic stroke, and was disclosed earlier this year during the annual scientific meeting of the Society of Interventional Radiology (SIR) by Kieran Murphy, vice chair and deputy chief of Medical Imaging and director of Medical Imaging Research at the University of Toronto. 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.”
The Nautilus NeuroWave system is an investigational device in the USA.