Updated: May 19, 2021
To Support Targeted Commercialization and Global Partnering of FDA-Approved Non-Drug Treatment for Pediatric ADHD
LOS ANGELES, Sept. 21, 2020 (GLOBE NEWSWIRE) -- NeuroSigma, Inc. (“NeuroSigma”), a Los Angeles-based bioelectronics company, is pleased to announce the receipt of bridge equity financing from Checkmate Capital Group (“Checkmate Capital”) of Pasadena, California.
The financing supports NeuroSigma’s transition from a clinical-stage to a commercial-stage company, focused on (i) a targeted commercial launch in the US of its patented Monarch® eTNS® System to treat pediatric ADHD and (ii) partnering with established pharmaceutical and medical device companies outside the US for ADHD and other indications. The prescription-only Monarch® eTNS® System (Monarch) is indicated in the US as a monotherapy treatment of pediatric ADHD for patients ages 7 through 12 years old who are not currently taking prescription ADHD medications. The Monarch is intended to be used in the home under the supervision of a caregiver during periods of sleep. In the European Union, the device has CE mark approval as adjunctive therapy for drug resistant epilepsy and major depressive disorder, as well as monotherapy for ADHD, all in patients 7 years and older.
Checkmate Capital’s investment represents the first institutional equity investment in NeuroSigma and supplements tens of millions of dollars NeuroSigma has received previously from accredited investors and US National Institutes of Health (NIH) grants, which have funded the company through its clinical stage. The new bridge financing will assist NeuroSigma’s transition to the commercial stage of its development. In addition to investing in NeuroSigma, Checkmate Capital has agreed to provide certain commercial and transactional services to NeuroSigma with regard to international licensing, partnerships and other commercial initiatives.
“We are delighted by Checkmate Capital’s investment and appreciate the collaborative working relationship we have developed with the Checkmate Capital team,” said NeuroSigma’s CEO, Leon Ekchian, Ph.D. “The funding comes as NeuroSigma has been gaining momentum, both financially and commercially. Last year, the Monarch became the first non-drug treatment approved by the FDA for pediatric ADHD. In October of 2019, NeuroSigma announced its exclusive partnership with Teijin Pharma with respect to eTNS for ADHD in the Japanese market. Now, as physicians have been gravitating toward home-based, contactless treatment because of COVID, there has been ever-increasing interest in digital therapeutics and in-home health care solutions. In this environment, our eTNS technology has received significant attention,” added Ekchian.
Checkmate Capital’s CEO, Tom Paschall, commented that, “We are excited about NeuroSigma’s near-term opportunities as the company optimizes and commercializes its valuable eTNS platform on multiple fronts. As experienced life sciences investors, it is rare for us to be the first institutional equity capital in such a late-stage, commercialization-ready company with a de-risked, FDA-approved product for a major market like ADHD and with a mature pipeline for other neuropsychiatric and neurological indications, including epilepsy, PTSD, depression, and traumatic brain injury. We have also been impressed with NeuroSigma’s substantial US and international patent protection. We agree with industry experts who have recently commented in an article upon the exceptional nature of NeuroSigma’s patent portfolio and de novo 510(k) clearance, highlighting the significant protections NeuroSigma has secured for its long-term commercialization plans. We look forward to working with NeuroSigma as it commercializes its ADHD product and further develops its pipeline.”
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) involves 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.