FDA grants breakthrough designation for device to treat MDD in adults

The FDA has granted breakthrough device designation to Magnus Medical for its neuromodulation treatment of major depressive disorder in adults who failed to achieve improvement from previously prescribed antidepressants.

“Today’s FDA’s clearance for the SAINT Neuromodulation System is a major milestone in our long-term journey to restore and sustain mental health,” Brett Wingeier, PhD, co-founder and CEO of Magnus, said in a press release from Magnus Medical. “We look forward to seeing this work make a positive impact for the millions of people affected by neuropsychiatric disease.”

According to the release, the SAINT Neuromodulation System is intended to help patients receive timely access to breakthrough technologies with the potential to provide more effective treatment for life-threatening or debilitating conditions than previous therapies. SAINT utilizes structural and functional magnetic resonance imaging to inform a proprietary algorithm that identifies the optimal anatomic target for focused neurostimulation in people with MDD. The treatment is delivered on an accelerated timeline and is precisely tailored to each person’s brain connectivity.

The American Journal of Psychiatry published results from a double-blind, randomized controlled trial evaluating SAINT, which showed 79% of participants in the active treatment arm entered remission from their depression, compared to 13% in the sham treatment arm, per the release.

“This clearance expands the way we can use TMS to treat depression,” Mark S. George, MD, director of the Brain Stimulation Division at the Medical University of South Carolina, said in the release. “The older approaches often took 6 weeks for depression to respond, while this approach observed remission from depression in just 5 days. That opens up many new possibilities to use SAINT in hospitalized patients, for patients who present to the emergency room, and with different schedules in clinics.’'

Wingeier said that Magnus expects the commercial launch of SAINT to commence in the latter stages of 2023.