NeuroSigma, Inc., a California-based medical device company, today announced it received a Notice of Award, for a Fast Track Small Business Innovation Research (SBIR) grant, from the National Institute of Neurological Disorders and Stroke (NINDS) of the National Institutes of Health (NIH). Phase I of the project is budgeted in the amount of $600,000, with $3 Million budgeted for Phase II, subject to the availability of funds and satisfactory progress by NeuroSigma.
The funding supports further development of NeuroSigma's implantable subcutaneous trigeminal nerve stimulation (sTNSTM) System, culminating in a pilot human trial of sTNS in patients with drug resistant epilepsy (DRE). The project builds on the positive results from the randomized controlled trial of NeuroSigma's non-invasive, external TNS (eTNSTM) System, as reported online in the January 30, 2013 issue of Neurology®. The eTNS System is composed of an external pulse generator and electric patches placed on the forehead, primarily while the patient is asleep.
Together, eTNS and sTNS offer a complementary platform. Some patients may choose to remain on eTNS whereas others may opt to transition to sTNS. eTNS may serve as a means to screen for sTNS candidates prior to committing to sTNS surgery.
Once both sTNS and eTNS are approved by regulatory agencies the following integrated therapy path would be available. First, patients could commence with the eTNS treatment. Responders to the eTNS therapy could be identified with the relatively low cost and minimal risk afforded by eTNS. Then, those that respond to eTNS, and wish to transition to an implantable version, could be implanted with the more permanent, minimally-invasive, extra-cranial (under the skin but outside the skull) sTNS System. The sTNS electrodes would be implanted under the skin of the forehead while the pulse generator would be implanted pectorally.
In addition to this SBIR grant, NeuroSigma is currently performing under a separate Small Business Technology Transfer (STTR) grant from NINDS focused on optimization of its eTNS external electric patches.
Christopher M. DeGiorgio , M.D., Vice President of Neurology at NeuroSigma and Professor of Neurology at the University of California, Los Angeles (UCLA), will serve as the Principal Investigator (PI). Colin Kealey , M.D., Manager of Product Development at NeuroSigma, will serve as co-PI. "We are extremely pleased by the recognition and continuing support of the NINDS, knowing that its highly regarded peer review process includes a rigorous review by leading medical experts," said Dr. DeGiorgio. "We look forward to working closely with the NINDS Project Scientists in this Cooperative Program in Translational Research," added Dr. Kealey.
"This is our third NIH grant. As a small business we applaud the support of the NIH in transitioning promising technologies from the laboratory to the clinic," said Leon Ekchian, Ph.D., President & CEO of NeuroSigma.