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 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.