Nervive, Inc. has been awareded a $3.1 million grant from the National Institutes of Health to advance clinical testing of its medical device, the VitalFlow™ stimulator, as an emergency treatment for stroke. The three-year grant has been awarded through the CREATE Devices program that provides a collaborative partnership with the National Institute of Neurological Disorders and Stroke (NINDS).
“The CREATE Devices program is designed to help researches translate innovative therapeutic devices for treating neurological disorders through preclinical and early clinical studies in pursuit of future FDA market approval,” said Nick Langhals, Ph.D., Program Director of NINDS. “We are glad to see this project advance development and evaluation of a treatment for patients with ischemic stroke.”
Globally, stroke is the most common cause of disability and the second most common cause of death. More than 16 million people suffer a stroke each year, costing approximately $37 billion in healthcare expenditures. The number and burden of stroke cases is expected to increase into the foreseeable future.
The Vitalflow™ is a novel platform technology that stimulates the facial nerve using non-invasive pulsed magnetic energy, resulting in increased blood flow to the brain. The VitalFlow™ is expected to improve the effectiveness of existing emergency stroke treatments, increasing the delivery of tPA and other clot-busting drugs to the site of arterial obstruction and facilitating the navigation of clot-retrieval catheters through the dilated arteries of the brain. Additionally, the VitalFlow™ is expected to function as a stand-alone treatment for the large number of stroke patients who cannot receive existing emergency stroke treatments. Prior to stroke treatment, a version of the VitalFlow™ is being prepared for market entry in 2018 as a treatment for cerebral artery vasospasm (a stroke-like condition) that occurs in intensive care units. Subsequent versions of the VitalFlow™ will be used to treat stroke in the emergency department and ambulance.
The proposed CREATIVE Devices project is an Early Feasibility Clinical Study in ischemic stroke patients that will provide initial clinical data on the safety, tolerability, and effectiveness of the VitalFlow™ as an emergency treatment for ischemic stroke. The data from this study will justify larger, definitive clinical studies of the VitalFlow™, leading toward regulatory approval as an emergence treatment for stroke.