LOS ANGELES, Oct. 8, 2019 /PRNewswire/ -- NeuroSigma, Inc., a Los Angeles-based bioelectronics company focused on developing Trigeminal Nerve Stimulation (TNS) technology for treating neurological and neuropsychiatric disorders today announced a partnership with Quick Care Pharmacy, a California-based specialty pharmacy, for sales and distribution of its Monarch eTNS System® (Monarch) for the treatment of pediatric ADHD in the United States.
"NeuroSigma's Early Access program for the Monarch commenced in August, and we have been very pleased with the results. Our partnership with Quick Care will allow us to expand the Early Access Program to all 50 states and serve a wider physician and patient base," said Leon Ekchian, Ph.D., NeuroSigma's President and CEO.
On April 19, 2019, the Monarch received marketing clearance from FDA via the de novo pathway, which is typically used for clearance of novel medical devices that are deemed low- to moderate- risk. The Monarch is the first-ever medical device to receive FDA clearance for treating ADHD. Results from the double-blind pivotal trial of the Monarch for treating pediatric ADHD were published in the April 2019 issue of the Journal of the American Academy of Child and Adolescent Psychiatry. The trial's primary endpoint was the ADHD-RS-IV scale, a scale for assessing ADHD severity that is commonly used in clinical trials of ADHD therapies. After 4 weeks, children randomized to the treatment group showed significant improvements on the ADHD-RS-IV scale as compared to the control group (p = 0.005). The most common side effects observed with eTNS use are: drowsiness, an increase in appetite, trouble sleeping, teeth clenching, headache and fatigue. No serious adverse events were associated with use of the device.
"The Monarch represents a new treatment paradigm for pediatric ADHD," said Rohit Sheta, President and CEO of Quick Care. "We look forward to working with NeuroSigma on early commercialization of this exciting product. Quick Care's expertise will help NeuroSigma quickly scale to meet demand for the Monarch eTNS System throughout the United States," added Sheta.
For more information about the Monarch eTNS System. Please visit www.monarch-etns.com
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 attention-deficit hyperactivity disorder (ADHD) and other disorders.
Trigeminal Nerve Stimulation (TNS) is mild 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.
eTNS, 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), covering a wide-spectrum of disorders, including ADHD. 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.
Dr. Leon Ekchian, President & CEO
SOURCE NeuroSigma, Inc.