BELLEVUE, Wash.,
Nov. 3, 2011 /PRNewswire/ — PhysioSonics announced today that it received a
$2.5 million grant from the Telemedicine and Advanced Technology
Research Center.
TATRC is an organization within the headquarters of the U.S. Army Medical
Research and Materiel Command, located at Fort
Detric, Maryland.
With this grant, PhysioSonics will optimize its proprietary cerebral blood-flow
monitor to detect vasospasm. Following a successful launch in the civilian
healthcare market, the military will test the blood-flow monitor with the goal
of deploying it at military facilities that care for soldiers with traumatic
brain injuries (TBI).
Blast-induced TBI is a common occurrence on the battlefield,
and can be among the most devastating and difficult to detect. Vasospasm refers
to a condition in which the blood vessels shudder, leading to vasoconstriction,
or shrinkage of the vessels, causing reduced blood flow within the brain. This
can result in brain damage or even death. Vasospasm occurs in nearly half of
blast-induced TBI victims. The ability to monitor soldiers at high risk for
vasospasm can lead to potentially life-saving, preventative treatments. Monitoring
their treatment for vasospasm, once it occurs, can also reduce morbidity and
mortality. Vasospasm is difficult to detect and monitor with currently
available technology.
“PhysioSonics has developed a simple to use, portable
monitor that can automatically identify the mid-cerebral artery and provide a
continuous read of the blood’s flow and peak velocity,” said Brad Harlow,
CEO of PhysioSonics. “This is essential for diagnosing and monitoring
vasospasm. Transcranial Doppler ultrasound – the current technology standard –
relies on highly trained medical personnel and is therefore too awkward and
expensive to be deployed near combat, or even at high volume military
hospitals. We believe that our blood flow monitor, adapted for the rigors of
military use, can help clinicians accurately monitor for vasospasm among
soldiers injured by a blast, from an improvised explosive device, a land mine,
or another traumatic explosion.”
Use of PhysioSonics’ cerebral blood flow device for
detecting vasospasm is investigational and not an approved use in the United States.
The company recently completed a clinical study of its blood flow monitor that
showed parity with transcranial Doppler ultrasound. It intends to file a 510k
application for the blood-flow monitor with the U.S. Food and Drug
Administration.
Upon commercialization, the company intends to sell the
device and disposables to hospitals with neurosurgery and cardiac surgery
suites in the U.S.
It will later submit a pre-market approval application to the FDA to add a
non-invasive intracranial pressure monitoring indication to the device.
About PhysioSonics
PhysioSonics has developed a user-independent, non-invasive, long-term cerebral
blood flow (CBF) and emboli monitor. Utilizing novel ultrasound technology, the
company has developed a new method that enables the device to automatically
locate and hold on the cerebral artery without a trained sonographer. This
auto-locating ultrasound technology thus enables an easy-to-use method for the
continuous monitoring of CBF and emboli.
