Neuronetics has discovered a new advanced therapy system ‘NeuroStar’ for the treatment of bipolar depression.
Neurostar Advanced Therapy, a non-invasive form of neuromodulation, is the market leader in Transcranial Magnetic Stimulation (TMS). The therapy uses magnetic pulses to stimulate areas of the brain that are underactive in depression.
With the breakthrough device designation, the therapy could potentially provide more effective treatment with limited safety concerns to individuals with unipolar major depression.
It stimulates areas of the brain underactive in depression magnetic pulses, widely used by doctors for patients with Major Depressive Disorder (MDD).
Patients and healthcare providers would get more timely access to breakthrough technologies. These technologies have the potential to provide simpler treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.
The system aims to treat Bipolar I or Bipolar II disorders in patients who failed to receive improvement from prior pharmacological therapies.
The program creates an expedited pathway for prioritized FDA review of the NeuroStar clinical trial programme. The company has already submitted initial clinical plans to the agency for discussion.
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.