Clearance allows for more access to non-drug, noninvasive treatment for patients suffering from MDD or OCD
MALVERN, Pa., May 10, 2022 (GLOBE NEWSWIRE) -- Neuronetics, Inc. (NASDAQ: STIM), a commercial stage medical technology company focused on designing, developing, and marketing products that improve the quality of life for patients who suffer from neurohealth disorders, announced clearance from the U.S. Food and Drug Administration (FDA) for its transcranial magnetic stimulation system as an adjunct for treating adult patients suffering from Obsessive-Compulsive Disorder (OCD).
“This is evidence of our commitment and strategic initiative to accelerate new clinical indications for NeuroStar,” stated Cory Anderson, VP of R&D and Clinical. “This new indication means that NeuroStar can help even more people suffering from mental health disorders that can be debilitating in their daily lives.”
NeuroStar pioneered the TMS category as the first system FDA cleared for Major Depressive Disorder (MDD). NeuroStar is now leveraging the system’s versatile coil design, which allows providers to treat both MDD and OCD 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 Training Managers will be available to deliver training to NeuroStar practices in the third quarter. This new indication will significantly add to NeuroStar's extensive Outcomes Registry, which is the largest outcomes registry in the world for depression.
“Despite the severe functional impairment that OCD can cause, unfortunately, only one third of individuals with OCD seek treatment,” said Scott West, MD, Chief Medical Officer at Nashville NeuroCare Therapy. “NeuroStar receiving FDA clearance for OCD is important for my practice because more patients will have access to an effective and safe TMS treatment for both MDD and OCD without needing to buy any new equipment.”
For more information about NeuroStar Advanced Therapy for Mental Health, please visit neurostar.com
OCD is a mental health disorder characterized by uncontrollable thoughts and fears (obsessions), which may lead to repetitive behavior (compulsions). An estimated 4 million adults in the U.S. had OCD in the past year, and approximately one half (50.6%) had serious impairment. OCD can severely 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 therapeutic option. The NeuroStar Advanced Therapy system is intended to be used as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD).
Neuronetics, Inc. believes that mental health is as important as physical health. As a global leader in neuroscience and the largest TMS company in the industry, Neuronetics is redefining patient and physician expectations by designing and developing products that improve the quality of life for people suffering from psychiatric disorders. An FDA-cleared, non-drug, noninvasive 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 over 4.3 million treatments delivered. NeuroStar is widely researched and 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 information and indications for use, visit NeuroStar.com.