Michael Barbella, Managing Editor09.21.23
Neuronetics Inc. has received authorization from South Korea's Ministry of Food and Drug Safety (MFDS) for multiple features of NeuroStar TMS (transcranial magnetic stimulation), including an expansion of the indication to now involve 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,” Neuronetics President/CEO Keith J. Sullivan said. “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.”
South Korean patients with depression struggle with the side effect burden of systemic medications that are used as second, third, and fourth line therapy. The lifetime prevalence of MDD in the country is 6.7%, representing nearly 3.5 million adults struggling with depression among the country's 51 million residents.1 South Korea also reportedly has 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.
As a global leader in neuroscience, Neuronetics is redefining patient and physician expectations with its NeuroStar Advanced Therapy for Mental Health. NeuroStar is a non-drug, noninvasive treatment designed to improve the quality of life for people suffering from neurohealth conditions when traditional medication hasn’t helped. NeuroStar is U.S. Food and Drug Administration-cleared 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 over 5.4 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.
References
1 Shin C, et al. (2017) Assessment of Depression in General Population of Korea. J Korean Med Sci 32: 1861-1869. doi: 10.3346/jkms.2017.32.11.1861
2 Jang, H, et al. (2022) Suicide rate and social environment characteristics in South Korea: the roles of socioeconomic, demographic, urbanicity, general health behaviors, and other environmental factors on suicide rate. BMC Public Health 22, 410. https://doi.org/10.1186/s12889-022-12843-4
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,” Neuronetics President/CEO Keith J. Sullivan said. “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.”
South Korean patients with depression struggle with the side effect burden of systemic medications that are used as second, third, and fourth line therapy. The lifetime prevalence of MDD in the country is 6.7%, representing nearly 3.5 million adults struggling with depression among the country's 51 million residents.1 South Korea also reportedly has 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.
As a global leader in neuroscience, Neuronetics is redefining patient and physician expectations with its NeuroStar Advanced Therapy for Mental Health. NeuroStar is a non-drug, noninvasive treatment designed to improve the quality of life for people suffering from neurohealth conditions when traditional medication hasn’t helped. NeuroStar is U.S. Food and Drug Administration-cleared 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 over 5.4 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.
References
1 Shin C, et al. (2017) Assessment of Depression in General Population of Korea. J Korean Med Sci 32: 1861-1869. doi: 10.3346/jkms.2017.32.11.1861
2 Jang, H, et al. (2022) Suicide rate and social environment characteristics in South Korea: the roles of socioeconomic, demographic, urbanicity, general health behaviors, and other environmental factors on suicide rate. BMC Public Health 22, 410. https://doi.org/10.1186/s12889-022-12843-4