Magnus Medical’s SAINT Neuromodulation System Gains FDA Nod for Depression

Magnus Medical has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its SAINT neuromodulation system to treat major depressive disorder (MDD) in adults who haven’t improved with prior antidepressant medications.
 
“Magnus’ SAINT technology is groundbreaking and could help many patients with major depressive disorder (MDD) who have not responded to treatment with antidepressants,” said Alan F. Schatzberg, M.D., the Kenneth T. Norris, Jr. Professor of Psychiatry and Behavioral Sciences at Stanford University, and a Past President of the American Psychiatric Association. ”The treatment effects observed with SAINT treatment in the double-blinded, randomized controlled trial that was published in the American Journal of Psychiatry were dramatic, rapid, and frequently sustained through the study follow-up period. The technology could result in a fundamental change in the treatment approach to patients with refractory MDD and has the potential to reduce both the morbidity and mortality associated with the disorder.”
 
“This FDA clearance of the SAINT Neuromodulation System for depression is really exciting news,” said Mark S. George, M.D., distinguished professor of Psychiatry, Radiology and Neuroscience, and director of the Brain Stimulation Division, Psychiatry at the Medical University of South Carolina. “This is more than just clearance of another device. This clearance expands the way we can use TMS to treat depression. The older approaches often took six weeks for depression to respond, while this approach observed remission from depression in just five 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.”
 
The study showed 79% of people in the active treatment study arm entered remission from depression compared to 13% in the sham arm.
 
SAINT combines advanced imaging, personalized targeting, and novel stimulation patterns to create a new form of individualized neurostimulation for treatment-resistant depression. Structural magnetic resonance imaging (MRI) informs a proprietary algorithm to identify the best anatomic target for focused neurostim.
 
The technology was awarded FDA breakthrough device status last October.
 
“We are now at the forefront of an enormous improvement in the care of treatment-resistant depression, thanks to the work of the Magnus team and all those whose efforts have led to the SAINT technology. 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,” said Brett Wingeier, Ph.D., co-founder and CEO of Magnus. “More broadly, we look forward to seeing this work make a positive impact for the millions of people affected by neuropsychiatric disease. Our clinical research program will continue to yield more insights into how personalized neuromodulation can restore healthy neural activity across a wide variety of mental health conditions.
 
“We expect the commercial launch of our SAINT Neuromodulation System to begin later in 2023 on a limited basis, for which we are building a waitlist and engaging with an overwhelming number of teaching institutions, hospitals, clinics, interested clinicians, and medical professionals,” continued Dr. Wingeier.