NeuroStar TMS Wins Expanded Regulatory Approval in Japan

Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has approved multiple proprietary innovations for Neuronetics Inc.’s NeuroStar TMS (transcranial magnetic stimulation) Therapy System in treating major depressive disorder (MDD). The features covered in this approval include the NeuroStar 3.7 platform, MT Cap, D-Tect MT Accessory, and the Dash treatment protocol.
 
The Dash treatment protocol reduces the daily TMS treatment time from 38 minutes to under 19 minutes. MT Cap and D-Tect optimize efficiency for providers and patients by shortening the time and simplifying the steps to determine a patient’s motor threshold,  which is a critical step to establishing the patient’s prescription prior to starting treatment. The NeuroStar 3.7 platform continues Neuronetics’ strategy to standardize the NeuroStar hardware globally and includes advancements designed to streamline a clinician’s workflow, including 60% more computing power and a touchscreen display with a biometric fingerprint reader.
 
“Depression has emerged as a serious concern for the people of Japan. Since NeuroStar was approved through Japan’s rigorous Shonin pathway in 2017, we have remained committed to supporting patients and clinicians in Japan who are looking for treatments beyond medication,” Neuronetics President/CEO Keith J. Sullivan said. “We appreciate the engagement with PMDA on this approval and are looking forward to enhancing patient care and treatment efficiencies with our technology.”
 
As many as 2.4 million adults live with depression in Japan, with approximately 655,000 under a doctor’s treatment. Of those receiving treatment, 475,000 patients have failed to achieve remission from depression through antidepressant medications, experts estimate. NeuroStar TMS Therapy aims to fill this unmet need through its exclusive distribution partnership with Teijin Pharma Limited.
 
NeuroStar is advancing its global strategy and strengthening its global presence with recent regulatory approval in South Korea, as well as EU-MDR and MDSAP certifications. 
 
Neuronetics Inc. is redefining patient and physician expectations with its NeuroStar Advanced Therapy for Mental Health. NeuroStar is a non-drug, noninvasive treatment that can improve the quality of life for people suffering from neurohealth conditions when traditional medication has not helped. In the United States, NeuroStar is cleared by the U.S. Food and Drug Administration for adults with major depressive disorder (MDD), as an adjunct for adults with obsessive-compulsive disorder (OCD), and to decrease anxiety symptoms in adult patients with MDD that may exhibit comorbid anxiety symptoms (anxious depression). NeuroStar Advanced Therapy is a transcranial magnetic stimulation (TMS) treatment for MDD in adults, with more than 5.9 million treatments delivered. NeuroStar is backed by the largest clinical data set of any TMS system for depression, including the world’s largest depression Outcomes Registry.