LOS ANGELES, Sept. 6, 2011 /PRNewswire/ — NeuroSigma, Inc., a
Los Angeles-based medical device company, today announced it has
received a notice of award for an NIH Small Business Technology
Transfer (STTR) Phase I grant from the National Institute of
Neurological Disorders and Stroke (NINDS). This will support
further development of external trigeminal nerve stimulation
(eTNS™) therapy for the treatment of drug-resistant epilepsy,
for which NeuroSigma is the exclusive worldwide licensee of
intellectual property developed by the University of California,
Los Angeles (UCLA). The STTR program requires that the small
business collaborates with a non-profit research institution, which
must perform at least 30% of the work. UCLA’s role as a
subcontractor in this project is primarily focused on conducting
the human clinical studies.
NeuroSigma’s grant award from NINDS extends over a period of
approximately two years and will provide total funding of
approximately $750,000, with the second year of funding subject to
the availability of funds and satisfactory progress during the
first year. The NINDS STTR program may provide up to an
additional $3 million of follow-on Phase II funding for additional
clinical studies. The major focus of the project is clinical
testing of a new proprietary eTNS™ pulse generator
and animal and human testing of a new generation of
electrodes designed to mitigate minor skin irritation, which was
the primary side-effect reported by subjects in the Phase I and
recently completed Phase II clinical trials.
NeuroSigma’s eTNS™ system utilizes a self-adhesive
conductive pad applied to the forehead to stimulate branches of the
trigeminal nerve, which are located very close to the surface of
the skin of the forehead. The trigeminal nerve is the largest
cranial nerve, offering a high-bandwidth pathway for signals to
enter the brain.
Drs. Christopher
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