MALVERN, Pa., May 10, 2022 (GLOBE NEWSWIRE) — Neuronetics, Inc. (STIM), a commercial-stage medical technology company focused on designing, developing and commercializing products that improve the quality of life for patients with neurohealth disorders, announced US Food and Drug Administration (FDA) clearance for its transcranial magnetic stimulation system as an adjunct to the treatment of adult patients with obsessive-compulsive disorder (OCD).
“This is proof of our commitment and strategic initiative to accelerate new clinical indications for NeuroStar,” said Cory Anderson, Vice President R&D and Clinical. “This new indication means that NeuroStar can help even more people with mental health conditions that can be disabling in their daily lives.”
NeuroStar pioneered the TMS category as the first FDA cleared system for Major Depressive Disorder (MDD). NeuroStar now takes advantage of the system’s versatile coil design, which allows providers to process both CT and TOC without the need for additional hardware upgrades or purchases. NeuroStar’s proprietary cloud-based software, TrakStar, can remotely activate the new treatment protocol for providers once they are trained. Practice Development Managers and Clinical Education Managers will be available to provide training in NeuroStar practices during the third quarter. This new indication will significantly enrich NeuroStar’s extensive outcome registry, which is the world’s largest depression outcome registry.
“Despite the severe functional impairment that OCD can cause, unfortunately only one-third of people with OCD seek treatment,” said Scott West, MD, chief medical officer of Nashville NeuroCare Therapy. “NeuroStar receiving FDA clearance for OCD is important to my practice because more patients will have access to effective and safe TMS treatment for MDD and OCD without the need to purchase new equipment.”
For more information on NeuroStar Advanced Therapy for Mental Health, please visit neurostar.com
OCD is a mental health disorder characterized by uncontrollable thoughts and fears (obsessions), which can lead to repetitive behaviors (compulsions). An estimated 4 million adults in the United States have had OCD in the past year, and about half (50.6%) had severe impairment. OCD can seriously affect daily life and routines and cause distress or even functional impairment. Some patients with OCD have limited results from pharmaceutical and psychological interventions and need another treatment option. The NeuroStar Advanced Therapy System is intended for use as an adjunct in the treatment of adult patients with Obsessive Compulsive Disorder (OCD).
Neuronetics, Inc. believes that mental health is as important as physical health. As the world leader in neuroscience and the industry’s largest TMS company, Neuronetics is redefining patient and physician expectations by designing and developing products that improve the quality of life for people with psychiatric disorders. A non-invasive, non-drug, FDA-approved treatment for people with depression and OCD, Neuronetics’ NeuroStar® Advanced Therapy System is today’s leading transcranial magnetic stimulation (TMS) treatment for major depressive disorder with more than 4.3 million treatments administered. NeuroStar is extensively researched and backed by the largest clinical data set of any TMS system for depression, including the world’s largest registry of depression outcomes. Neuronetics is committed to transforming lives by delivering exceptional treatment that produces extraordinary results. For safety information and directions for use, visit NeuroStar.com.