FDA Grants NeuroSigma Humanitarian Use Device (HUD) Designation

Treatment of Lennox-Gastaut with External Trigeminal Nerve Stimulation

Jan 06, 2015, 07:00 ET from NeuroSigma

LOS ANGELES, Jan. 6, 2015 /PRNewswire/ -- NeuroSigma®, Inc. (NeuroSigma) today announced that it has received a Humanitarian Use Device (HUD) designation from the Food and Drug Administration (FDA) for its eTNS neuromodulation therapy for the adjunctive treatment of the symptoms of Lennox-Gastaut Syndrome (LGS). The HUD designation is the first step in obtaining a Humanitarian Device Exemption (HDE) for the eTNS system. An approved HDE would allow NeuroSigma to market the eTNS system in the United States as an adjunctive treatment for the symptoms of LGS in children.

NeuroSigma estimates that up to 2085 children experience the onset of LGS each year in the U.S. and believes that these children could benefit from eTNS treatment.  LGS is a rare and catastrophic, progressive encephalopathic brain disorder with childhood onset, clinically marked by impaired intellectual functioning, developmental delay, behavioral disturbances, and the presence of multiple types of seizures, including "drop attacks."  It is recognized as a rare disease by the FDA's Office of Orphan Product Development (OOPD).

"Our eTNS system may become an attractive adjunctive treatment for many children with Lennox-Gastaut Syndrome.  It is a non-invasive neuromodulation system that these children and their families can use in the home if an HDE is approved.  Many patients still suffer from the symptoms of this devastating condition despite best current medical practice.  We have already begun collecting the human clinical data necessary to apply for the HDE," said Ian Cook, M.D., NeuroSigma's Chief Medical Officer.

"We are delighted by this development as it is a major step towards our first regulatory approval in the United States," said David Hayes, Chief Administrative Officer and General Counsel of NeuroSigma.

NeuroSigma is a California-based life sciences company focused on commercialization of its non-invasive eTNS technology for the treatment of neurological and neuropsychiatric disorders. NeuroSigma's Monarch eTNS system is currently approved in the European Union for the adjunctive treatment of major depressive disorder and in Canada for treatment of major depressive disorder, in each case for adults and children nine years and older. In the United States, the Monarch eTNS system is an investigational device and is limited by Federal law to investigational use.

The Monarch eTNS system is composed of a cell-phone sized pulse generator and a single-use patch that is applied to the forehead.  Signals are transmitted through lead wires to the patch in order to stimulate the trigeminal nerve in the skin of the forehead; triggering these nerve fibers sends signals to targeted brain regions and changes the activity there.  Patients may conveniently self-administer the Monarch eTNS system at home and typically use the device while sleeping.

Background – TNS

The trigeminal nerve is the largest cranial nerve, offering a high-bandwidth pathway for signals to enter the brain, bilaterally and at high frequency. The trigeminal nerve projects directly or indirectly to specific areas of the brain, such as the locus coeruleus, nucleus tractus solitarius, thalamus, and the cerebral cortex, which are involved in epilepsy, depression, post-traumatic stress disorder (PTSD), attention-deficit hyperactivity disorder (ADHD), traumatic brain injury (TBI), and other disorders.

Trigeminal Nerve Stimulation (TNS) is the electrical stimulation of branches of the trigeminal nerve, including those located near the surface of the forehead. Functional neuroimaging data suggests the mechanism of action of TNS is related to its ability to modulate activity in targeted brain regions.

CAUTION: In the United States, the eTNS and sTNS systems are investigational devices and are limited by Federal law to investigational use.  The U.S. Food and Drug Administration (FDA) has given NeuroSigma approval to proceed with a pivotal Phase III clinical trial of external TNS (eTNS) in drug-resistant epilepsy. Completion of that Phase III trial is necessary before the FDA will consider permitting the marketing and sale of eTNS in the United States.

eTNS, sTNS, Monarch, and Monarch eTNS are trademarks of NeuroSigma, Inc.

About NeuroSigma, Inc.

NeuroSigma is a California-based life sciences company established to develop bioelectronic technologies with the potential to transform medical practice and patients' lives.  NeuroSigma is focused on TNS neuromodulation therapies based on intellectual property licensed on an exclusive basis from the University of California, Los Angeles (UCLA), including TNS therapies for epilepsy, depression, PTSD, ADHD, and TBI. For more information about NeuroSigma, please visit www.neurosigma.com.

Forward-Looking Safe Harbor Statement

This press release contains forward-looking statements, including but not limited to, research and development outcomes, efficacy, adverse reactions, market and product potential, product availability and other statements regarding our eTNS system.  These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the Company's expectations and projections. Risks and uncertainties include, among other things, general industry and medical device market conditions; technological advances and patents attained by competitors; challenges inherent in the research and development and regulatory processes; challenges related to new product marketing, such as the unpredictability of market acceptance for new medical device products; inconsistency of treatment results among patients; potential difficulties in manufacturing a new product; general economic conditions; and governmental laws and regulations affecting domestic and foreign operations.


SOURCE NeuroSigma