MALVERN, PA — Neuronetics, Inc. (NASDAQ: STIM), a medical technology company, 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 Organization of Economic Cooperation and Development (OECD)2.
As a market leader in TMS within the South Korean market, NeuroStar aims to fill this unmet need and has partnered with distributor DK Healthcare to expand access to NeuroStar TMS. Further, NeuroStar continues its strategy to advance mental health care globally in strategically selected international markets by seeking clearance for new technological innovations and new indications as the supporting data become available.
For the latest news on everything happening in Chester County and the surrounding area, be sure to follow MyChesCo on Google News and MSN.