As reported in Globes.co.il: The approval is also an important breakthrough for the company, and opens an important US market.
Brainsway Ltd. announced that it has obtained US Food and Drug Administration (FDA) clearance for use of its Deep TMS (transcranial magnetic stimulation) device for the treatment of depression in patients who fail to respond to therapeutics during a depression episode. The company adds that the FDA approval for this indication is generally broader than the definition given by the company’s TMS device rival.
Brainsway said that the FDA certification of the Deep TMS device for use in the US for such a broad indication is further demonstration of the device’s efficacy and safety in treating depression, and could be an important milestone in changing the treatment for depression. The approval is also an important breakthrough for the company, and opens an important US market, which the company estimates at tens of billions of dollars a year.
Brainsway said that it was considering how to market and distribute the Deep TMS device in the US and other countries, including collaborations with experienced companies in the business.
Brainsway’s share price rose 35% by midday, after trading in the share was resumed, to NIS 44.79, giving a market cap of over NIS 500 million.