Neuronetics has secured breakthrough device designation from the US Food and Drug Administration (FDA) for its NeuroStar Advanced Therapy System to treat bipolar depression.
The system aims to treat Bipolar I or Bipolar II disorders in patients who failed to receive improvement from prior pharmacological therapies.
FDA designation should speed up the pathway for prioritised FDA review of the NeuroStar clinical trial programme. The company submitted initial clinical plans to the agency for discussion.
Neuronetics’ NeuroStar system is a non-invasive form of neuromodulation. It stimulates areas of the brain underactive in depression magnetic pulses, widely used by doctors for patients with Major Depressive Disorder (MDD).
Neuronetics commercial access vice-president Yelena Tropsha said: “We are delighted that the FDA has accepted our application for Breakthrough Device Designation and look forward to working closely with them to provide a potential solution for people with bipolar depression.
“This potential new treatment indication for NeuroStar means that millions of people with bipolar disorder who do not respond to medications may have a proven, non-drug treatment available to them.
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“The Breakthrough Device Designation is an important milestone that further supports our mission of renewing lives by transforming neurohealth.”
Bipolar I and II disorders cause recurrent, dramatic shifts in mood, energy, and activity levels in patients. Bipolar disorder affects around 6.5 to seven million US adults every year.
In 2008, NeuroStar Advanced Therapy obtained FDA clearance for adults with MDD, also used in other parts of the world. In Japan, it is under national health insurance.