NeuroStar Achieves Milestone Regulatory Clearance in South Korea
17 Julho 2023 - 9:46AM
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 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 more information about NeuroStar, please
visit NeuroStar.com.
About NeuroneticsNeuronetics,
Inc. believes that mental health is as important as physical
health. 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 that
can improve the quality of life for people suffering from
neurohealth conditions when traditional medication hasn’t helped.
NeuroStar is FDA-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 the leading 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. Neuronetics is
committed to transforming lives by offering an exceptional
treatment that produces extraordinary results. For safety and
prescribing
information, www.neurostar.com.
Media
Contact:EvolveMKD646.517.4220NeuroStar@evolvemkd.com
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.2017.32.11.18612 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
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