Neuronetics Receives 510(k) Clearance for OCD MT Cap for NeuroStar Advanced Therapy

MALVERN, Pa., June 12, 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 today that they have received 510(k) clearance for their obsessive-compulsive disorder (OCD) Motor Threshold (MT) Cap technology for NeuroStar^® Advanced Therapy for Mental Health.

“This FDA clearance underscores our commitment to delivering the latest technology that will streamline the treatment process for our customers,” shared Cory Anderson, SVP of R&D and Clinical at Neuronetics. “The unique design and functionality of the OCD MT Cap will enable clinicians to optimize treatment efficiency while upholding the highest standard of care for their patients. This innovation also prepares NeuroStar for even further technological advancements expected later this year and next.”

Determining a patient’s Motor Threshold (MT) is a critical step to establish the patient’s prescription prior to starting treatment. NeuroStar stands out as the only TMS system with FDA clearance for MT Caps designed for both OCD and major depressive disorder (MDD). The MT Cap simplifies the initial NeuroStar coil placement by providing a consistent starting location and a step-by-step process to map a patient’s motor cortex, effectively shortening the time and reducing the number of steps involved. The OCD MT Cap shares the same advantages as the current MDD MT Cap. This includes its compatibility with Fast MT™, providing up to a 40% time savings for clinicians and patients during the initial visit.

“The current MT Cap for depression became an immediate staple in my practice, and I have witnessed its numerous benefits firsthand. I am thrilled with the addition of the FDA-cleared MT Cap for OCD,” said Dr. Kenneth Pages, Medical Director at TMS of South Tampa. “This new technology is an important development, as it will further empower my practice to provide effective and personalized care for individuals struggling with OCD.”

Nearly 300 patients with OCD have received treatment with NeuroStar TMS, with over 6,000 treatments delivered. The OCD MT Cap will be available at select sites starting this month, with nationwide availability expected in Q4. For more information about NeuroStar, please visit NeuroStar.com. 

About Neuronetics
Neuronetics, 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.

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