Neuronetics' NeuroStar TMS system receives FDA breakthrough designation for bipolar depression

Shares in Neuronetics jumped as much as almost 36% Friday after the company announced that its NeuroStar advanced therapy system was granted an FDA breakthrough device designation to treat bipolar depression in adults with bipolar I or bipolar II disorders who have failed to achieve adequate improvement from prior pharmacological therapy. The company said this makes NeuroStar the first transcranial magnetic stimulation (TMS) device to receive such a designation for this patient population.

Yelena Tropsha, Neuronetics' vice president of commercial access, remarked that "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."

According to Neuronetics, NeuroStar is a "non-invasive form of neuromodulation that uses magnetic pulses to stimulate areas of the brain that are underactive in depression." The company cited findings from an independent randomised study demonstrating that patients treated with TMS using a clinical-trial version of the NeuroStar TMS system were 4.2 times more likely to achieve remission compared to those receiving placebo.

The TMS device is currently cleared in the US and CE-marked in Europe to treat adults with major depressive disorder (MDD) who have failed to achieve satisfactory improvement from prior antidepressant medication. It is available in other parts of the world as well, including Japan, where it is also authorised to treat MDD in adults and listed under the country's national health insurance.

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