April 27, 2021 – “Adding our 3-minute treatment protocol to the list of growing solutions available to our provider partners expands the platform nature of this life-changing technology,” Hadar Levy, Senior Vice President and General Manager of BrainsWay, said to the press. “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.”1

In their application to the FDA, BrainsWay submitted safety and efficacy data from a study that enrolled 146 participants with MDD who received either standard deep TMS protocol or 3-minute theta burst protocol. Of the 146 patients, 80 received the 20-minute protocol and 66 received the theta burst 3-minute protocol. Both groups demonstrated statistically significant reductions in depression scores. The results met the equivalence criteria needed for the shorter treatment’s clearance.

The therapy uses BrainsWay’s H-1 coil helmet to excite or inhibit neurons in the prefront cortex using direct magnetic pulses. It is typically delivered 5 days a week for 4 weeks, and then adjusted based on patient response. Both treatments call for the same frequency and number of treatments, but the frequency of the pulses and inter-pulse breaks differ.



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