NeuroStar TMS Receives Expanded Regulatory Approval in Japan

Rhea-AI Summary

Neuronetics, Inc. (NASDAQ: STIM) has received approval from the PMDA in Japan for multiple proprietary innovations that significantly advance the patient treatment experience with the NeuroStar TMS Therapy System for the treatment of major depressive disorder (MDD). The features covered in this approval include the NeuroStar 3.7 platform, MT Cap, D-Tect™ MT Accessory, and the Dash treatment protocol. The Dash treatment protocol reduces the daily TMS treatment time from 38 minutes to under 19 minutes. Neuronetics is committed to supporting patients and clinicians in Japan who are looking for treatments beyond medication, with an exclusive distribution partnership with Teijin Pharma Limited. The company aims to fill the unmet need for patients who have failed to achieve remission from depression through antidepressant medications. NeuroStar is also advancing its global strategy and strengthening its global presence with recent announcements of regulatory approval in South Korea, as well as EU-MDR and MDSAP certifications.

Positive

• Approval from PMDA in Japan for multiple proprietary innovations
• Reduction of daily TMS treatment time from 38 minutes to under 19 minutes with the Dash treatment protocol
• Exclusive distribution partnership with Teijin Pharma Limited to support patients beyond medication
• Advancing global strategy with regulatory approvals in South Korea and EU-MDR and MDSAP certifications

Negative

• None.

Technological advances reduce time and increase efficiency for MDD treatment

MALVERN, Pa., Dec. 04, 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 Pharmaceuticals and Medical Devices Agency (PMDA) in Japan has approved multiple proprietary innovations, which significantly advance the patient treatment experience with the NeuroStar TMS (transcranial magnetic stimulation) Therapy System for the treatment of major depressive disorder (MDD) in Japan. The features covered in this approval include the NeuroStar 3.7 platform, MT Cap, D-Tect™ MT Accessory, and the Dash treatment protocol.

The Dash treatment protocol reduces the daily TMS treatment time from 38 minutes to under 19 minutes. MT Cap and D-Tect optimize efficiency for providers and patients by shortening the time and simplifying the steps to determine 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 continues Neuronetics’ strategy to standardize the NeuroStar hardware globally and includes advancements designed to streamline a clinician’s workflow, including 60% more computing power and a touchscreen display with a biometric fingerprint reader.

“Depression has emerged as a serious concern for the people of Japan. Since NeuroStar was approved through Japan’s rigorous Shonin pathway in 2017, we have remained committed to supporting patients and clinicians in Japan who are looking for treatments beyond medication,” stated Keith J. Sullivan, President, and CEO of Neuronetics Inc. “We appreciate the engagement with PMDA on this approval and are looking forward to enhancing patient care and treatment efficiencies with our cutting-edge technology.”

As many as 2.4 million adults live with depression in Japan, with approximately 655,000 of them being treated by a doctor. It is estimated that of those receiving treatment, 475,000 patients have failed to achieve remission from depression through antidepressant medications. NeuroStar TMS Therapy aims to fill this unmet need through its exclusive distribution partnership with Teijin Pharma Limited.

NeuroStar is advancing its global strategy and strengthening its global presence with recent announcements of regulatory approval in South Korea, as well as EU-MDR and MDSAP certifications. NeuroStar will continue 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 becomes available.

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. In the United States, 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 5.9 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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FAQ

What is the ticker symbol for Neuronetics, Inc.?

The ticker symbol for Neuronetics, Inc. is STIM on the NASDAQ stock exchange.

What are the proprietary innovations approved by the PMDA in Japan for Neuronetics, Inc.?

The PMDA in Japan has approved multiple proprietary innovations for Neuronetics, Inc., including the NeuroStar 3.7 platform, MT Cap, D-Tect™ MT Accessory, and the Dash treatment protocol.

How many adults live with depression in Japan?

As many as 2.4 million adults live with depression in Japan, with approximately 655,000 of them being treated by a doctor.

What is the aim of NeuroStar TMS Therapy?

NeuroStar TMS Therapy aims to fill the unmet need for patients who have failed to achieve remission from depression through antidepressant medications.

What recent regulatory approvals has Neuronetics, Inc. received?

Neuronetics, Inc. has received recent regulatory approval in South Korea, as well as EU-MDR and MDSAP certifications to advance its global strategy and strengthen its global presence.