Magnus Medical, Inc., a medical device company and developer of brain stimulation technology for treatment of neuropsychiatric disorders, today announced it received 510(k) clearance from the U.S. Food & Drug Administration (FDA) for the SAINTTM Neuromodulation System for the treatment of major depressive disorder (MDD) in adults who’ve failed to attain satisfactory improvement from prior antidepressant medications in the present episode.
“Magnus’ SAINT technology is groundbreaking and will help many patients with major depressive disorder (MDD) who haven’t 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 within the double-blinded, randomized controlled trial that was published within the American Journal of Psychiatry were dramatic, rapid, and incessantly sustained through the study follow-up period. The technology could lead to a fundamental change within the treatment approach to patients with refractory MDD and has the potential to cut back each the morbidity and mortality related to the disorder.”
This FDA clearance of the SAINT Neuromodulation System for depression is de facto exciting news. That is greater than just clearance of one other device. This clearance expands the way in which we are able to use TMS to treat depression. The older approaches often took six weeks for depression to reply, while this approach observed remission from depression in only five days. That opens up many latest possibilities to make use of SAINT in hospitalized patients, for patients who present to the emergency room, and with different schedules in clinics.”
Mark S. George, M.D., distinguished professor of Psychiatry, Radiology and Neuroscience, and director of the Brain Stimulation Division, Psychiatry on the Medical University of South Carolina
The American Journal of Psychiatry published results from a double-blinded randomized controlled trial (RCT) evaluating SAINT that shows 79% of individuals within the energetic treatment arm entered remission from their depression in comparison with 13% within the sham treatment arm.
The SAINT Neuromodulation System, which received Breakthrough Device Designation from the FDA, a program intended to assist patients receive more timely access to breakthrough technologies with the potential to offer more practical treatment for life-threatening or debilitating conditions than previous therapies, is a novel innovation that’s significantly impacting the treatment of severe depression. For the primary time, advanced imaging technologies combined with personalized targeting and novel stimulation patterns have yielded a latest type of individualized neurostimulation for individuals with treatment-resistant depression.
“We are actually on the forefront of an unlimited improvement within the care of treatment-resistant depression, because of 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 significant milestone in our long-term journey to revive and sustain mental health,” said Brett Wingeier, Ph.D., co-founder and CEO of Magnus. “More broadly, we look ahead to seeing this work make a positive impact for the tens of millions of individuals affected by neuropsychiatric disease. Our clinical research program will proceed to yield more insights into how personalized neuromodulation can restore healthy neural activity across a wide selection of mental health conditions.
“We expect the business launch of our SAINT Neuromodulation System to start later in 2023 on a limited basis, for which we’re constructing a waitlist and interesting with an amazing variety of teaching institutions, hospitals, clinics, interested clinicians, and medical professionals,” continued Dr. Wingeier.
The SAINT Neuromodulation System uses structural and functional magnetic resonance imaging (MRI) to tell a proprietary algorithm that identifies the optimal anatomic goal for focused neurostimulation in individuals with MDD. This latest approach is delivered on an accelerated timeline and is precisely tailored to everybody’s brain connectivity.