BrainsWay Ltd. announced 12-month durability data for its SWIFT Deep Transcranial Magnetic StMS protocol, demonstrating sustained clinical benefits for patients with Major Depressive Disorder. The findings, presented at the 14th Annual Clinical TMS Society Meeting, show that over 80% of patients treated with the SWIFT protocol remained in remission through the 12-month follow-up period. The data highlights the protocol's ability to reduce clinic visits by 70% during the acute phase while maintaining long-term efficacy.

The study, the first multisite, randomized, controlled trial to evaluate long-term outcomes of the SWIFT protocol, revealed significant improvements in functional impairment. Among patients receiving the SWIFT protocol, severe functional impairment decreased from 85% at baseline to 0% at 12 months. Less than 25% of patients required changes to their prescribed medication or additional TMS courses within the year.

Colleen Hanlon, PhD, Vice President of Medical Affairs at BrainsWay, emphasized the importance of durability in treatment. "This study demonstrates that the benefits of the SWIFT Deep TMS protocol extend well beyond the acute treatment phase," she said. The trial followed 65 patients from the original FDA pivotal study, evaluating them at 3, 6, 9, and 12 months using clinician-rated and patient-reported measures.

The SWIFT protocol, which received FDA clearance in September 2025, involves 5 sessions per day for 6 half days, followed by 4 weekly visits. This compares to the standard protocol of 1 daily session over 4 weeks, followed by 2 sessions per week for 2 weeks. The study found that both accelerated and standard protocols showed durable remission and response rates.

Hadar Levy, Chief Executive Officer of BrainsWay, noted the milestone for the field. "Demonstrating sustained remission and functional recovery over a full year represents an important milestone," Levy said. The data reinforces the clinical evidence for Deep TMS and supports the value of accelerated treatment protocols for depression.

Key Study Findings

The study builds on BrainsWay's existing clinical evidence, which includes three FDA-cleared indications for Deep TMS. The company continues to advance trials in psychiatric, neurological, and addiction disorders.