Benzinga | Apr 26, 2021 10:25AM EDT

BrainsWay Stock Is Trading Higher After FDA OK's Three-Minute Theta Burst Treatment Protocol For Major Depressive Disorder

* The FDA has granted 501(k) clearance for BrainsWay Ltd's (NASDAQ: BWAY) Theta Burst three-minute protocol utilizing its Deep Transcranial Magnetic Stimulation (Deep TMS) system for major depressive disorder (MDD).

* "Many patients and providers can benefit from significantly shorter treatment sessions, and our Theta Burst protocol can provide these patients with another option to manage their treatment-resistant depression," said Hadar Levy, Senior Vice President and General Manager.

* BrainsWay submitted safety and efficacy data from 146 subjects who had received either the standard Deep TMS protocol or the three-minute Deep TMS protocol.

* Subjects in both groups demonstrated a statistically and clinically meaningful reduction in depression scores, and the results met the equivalence criteria needed for clearance of the shorter treatment.

* The Theta Burst protocol will be immediately available on all BrainsWay systems already installed.

* Price Action: BWAY shares are trading 10.3% higher at $9.13 in the market hours on the last check Monday.