Business
NeuroStar Achieves Milestone Regulatory Clearance in South Korea
First International Approval for Expanded Indication and Certification for MT Cap and D-Tect™ Technologies MALVERN, Pa., July 17, 2023 (GLOBE NEWSWIRE) --
About this update from Neuronetics, Inc.
[{"type":"text","content":"First International Approval for Expanded Indication and Certification for MT Cap and D-Tect™ Technologies\nMALVERN, Pa., July 17, 2023 (GLOBE NEWSWIRE) -- Neuronetics, Inc. (NASDAQ: STIM), a medical technology company focused on designing, developing, and marketing products that improve the quality of life for patients who suffer from neurohealth disorders, announced that the Ministry of Food and Drug Safety (MFDS) in South Korea has authorized multiple features of NeuroStar TMS (transcranial magnetic stimulation) for sale and distribution in the country – including an expansion of the indication to now include patients with major depressive disorder (MDD) that exhibit comorbid anxiety symptoms, the NeuroStar 3.7 platform, MT Cap, and D-Tect™ MT Accessory. This marks the first international market where NeuroStar has obtained marketing authorization for the expanded indication and cutting-edge technologies. MT Cap and D-Tect optimize efficiency for providers and patients by shortening the time and reducing the number of steps involved in determining a patient’s motor threshold (MT), which is a critical step to establishing the patient’s prescription prior to starting treatment. The NeuroStar 3.7 platform standardizes the NeuroStar hardware globally and includes advancements designed to streamline a clinician’s workflow, such as a touchscreen display with a biometric fingerprint reader. “The regulatory milestone, which came several months ahead of schedule, is a notable achievement for NeuroStar,” stated Keith J. Sullivan, President, and CEO of Neuronetics Inc. “It affirms our commitment and strategy toward providing groundbreaking medical technologies to healthcare professionals worldwide. The approval in South Korea, along with our recent EU-MDR and MDSAP certifications, solidifies our position as a leader in the international medical device industry and underscores our mission to enhance patient care globally.” Patients in South Korea with depression, just like in the United States, struggle with the side effect burden of systemic medications that are used as 2nd, 3rd, and 4th line therapy. The lifetime prevalence of MDD in the country is 6.7%, representing nearly 3.5M adults struggling with depression among the population of 51M1. South Korea was also reported to have the greatest suicide rate among nations of the Organizati...