NeuroStar TMS Receives Expanded Regulatory Approval in Japan
04 Dezembro 2023 - 10:56AM
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 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.
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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Contact:EvolveMKD646.517.4220NeuroStar@evolvemkd.com
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