BrainsWay (Nasdaq:BWAY) today announced the FDA granted expanded clearance for its Deep Transcranial Magnetic Stimulation system to include an accelerated treatment protocol for major depressive disorder and patients with comorbid anxiety symptoms.
The accelerated protocol allows for an acute phase of six treatment days, compared to the four weeks of daily sessions required under the standard protocol. Each session lasts less than 10 minutes.
“We are excited to announce this important FDA clearance of an accelerated treatment protocol for our Deep TMS system, which we are confident will empower providers to treat more patients,” CEO Hadar Levy said in a news release. “More than just another clearance, this marks a pivotal advancement in the treatment of depression with Deep TMS because it expands the ways in which we can use Deep TMS to treat depression. While previously, treatment involved 4 weeks of daily treatment sessions before follow up visits, this newly cleared accelerated protocol includes an acute phase of just 6 treatment days.”
The company said the clearance was supported by a multicenter, randomized, blinded, controlled study. Results showed the accelerated Deep TMS protocol using intermittent theta burst stimulation produced comparable outcomes to the standard protocol, while requiring fewer clinic visits.
Depression scores measured by HDRS-21 were reduced by 19.02 points in the accelerated group versus 19.79 in the standard group. Response rates were 87.8% in the accelerated group and 87.5% in the standard group, while remission rates were 78.0% and 87.5%, respectively. Median time to remission was 21 days for the accelerated group compared to 28 days for the standard group. No severe adverse events were reported.
Levy said BrainsWay plans to provide training to healthcare providers and will seek reimbursement updates to support adoption of the accelerated protocol. Current reimbursement allows for up to two treatments per day.
The BrainsWay Deep TMS system is indicated for the treatment of depressive episodes and for decreasing anxiety symptoms in adult patients with major depressive disorder who did not respond to antidepressant medication in their current episode. The system also holds FDA clearances for obsessive-compulsive disorder and smoking addiction.
