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Hogan Lovells US LLP represented and assisted NeuroSigma in the review by CMS of NeuroSigma's application.
"We are extremely pleased by the decision of CMS to establish unique codes and want to thank CMS staff for their efforts during the review process to bring it to a timely and successful completion. We would also like to thank Dr. James McGough, lead investigator of the pivotal eTNS ADHD trial conducted at UCLA, for his assistance during the CMS review process," said Leon Ekchian, Ph.D., President & CEO of NeuroSigma.
"NeuroSigma's Monarch eTNS System was the first non-drug treatment for pediatric ADHD cleared by the FDA. Starting April 1st of this year, payers will be able to use these unique new HCPCS codes to establish coverage policies and payment decisions," said Ian Cook, M.D., Chief Medical Officer of NeuroSigma.
"CMS' decision to establish unique Level II HCPCS codes for both the Monarch eTNS System and refills of the disposable single use patches should facilitate access to this important new treatment modality by children with ADHD," said Colin Kealey, M.D., NeuroSigma's Vice President of Medical Affairs. "With the benefit of these new HCPCS codes, we look forward to building a commercial organization in the U.S. to offer children, parents, and physicians a compelling non-drug alternative to current medication treatment options for ADHD," added Kealey.
Background - eTNS
In the United States NeuroSigma's Monarch eTNS Systemis indicated for the treatment of pediatric Attention Deficit Hyperactivity Disorder (ADHD) as a monotherapy in patients ages 7 through 12 years old who are not currently taking prescription ADHD medications. The device is used for patient treatment by prescription only and is intended to be used in the home under the supervision of a caregiver during periods of sleep. 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 have been associated with use of the device.
In the European Union, the Monarch eTNSSystem is approved as adjunctive therapy for drug resistant epilepsy and major depressive disorder, as well as monotherapy for ADHD, all in patients 7 years and older.
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 is the external embodiment of TNS and is patent protected in the United States and other major potential markets. eTNS, Monarch, and Monarch eTNS are trademarks of NeuroSigma, Inc.
For more information on eTNS, please visit the Monarch eTNS website.
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 bioelectronics 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 reimbursement and 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.
Leon Ekchian, Ph.D.
President and CEO
SOURCE NeuroSigma, Inc.
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