The Telemedicine and Advanced Technology Research Center (TATRC) has funded PhysioSonics a $2.5 million grant which will enable the latter to optimize its cerebral blood-flow monitor to detect vasospasm, characterized by a condition where blood vessels shudder, leading to vasoconstriction or shrinkage of vessels, resulting in reduced blood flow in the brain.
The blood-flow monitor which has been introduced already in the civilian healthcare segment will undergo tests at the military facilities that treat army personnel with traumatic brain injuries (TBI), a condition that occurs in battlefields.
PhysioSonics CEO Brad Harlow said the company has developed a simplified portable monitor to automatically identify the mid-cerebral artery and provide blood flow and peak velocity reading.
"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," Harlow said.
The company has completed a clinical trial of its blood flow monitor which is investigational and not approved in the United States, showing parity with transcranial Doppler ultrasound, and plans to submit a 510k application with the US Food and Drug Administration (FDA).
Once commercialized, the device and disposables will be sold to hospitals with neurosurgery and cardiac surgery suites in the US and later file a pre-market approval application to the FDA to add a non-invasive intracranial pressure monitoring indication to the blood-flow monitor.