Magnus Medical announced today that it received FDA 510(k) clearance for its Saint neuromodulation system.
Burlingame, California-based Magnus designed Saint for the treatment of major depressive disorder (MDD). It treats adults who fail to achieve satisfactory improvement from prior antidepressant medications in the current episode.
The individualized, rapid-acting, non-invasive neurostimulation platform demonstrated the potential to be a reproducible, rapid and highly effective treatment for severe, refractory depression in a broader clinical setting. It received FDA breakthrough device designation in October 2021.
Saint combines advanced imaging technologies and personalized targeting and novel stimulation patterns. It uses structural and functional MRI to inform a proprietary algorithm. The algorithm identifies the optimal anatomic target for focused neurostimulation in people with MDD.
Results of a trial published in the American Journal of Psychiatry showed that 79% of people in the active treatment arm entered remission from their depression. That compared to 13% in the sham treatment arm. Magnus said in a news release that the new “individualized” neurostimulation provides a new option for treating depression.
“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, 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.”
Wingeier said the company expects a commercial launch for Saint later in 2023. It will begin on a limited basis, he said.
“Magnus’ Saint technology is groundbreaking and could help many patients with major depressive disorder (MDD) who have not responded to treatment with antidepressants,” said Dr. Alan Schatzberg, 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.”