Magnus Medical secures FDA clearance for its SAINT neuromodulation system to treat major depressive disorder (MDD).
Magnus Medical is a privately held medical device company that is developing a brain stimulation technology designed to treat people suffering from major depressive symptoms who have not responded to existing treatments.
The SAINT neuromodulation system uses structural and functional magnetic resonance imaging (MRI) to inform a proprietary algorithm that identifies the optimal anatomic target for focused neurostimulation in people with MDD.
This new approach is delivered on an accelerated timeline and is precisely tailored to each person’s brain connectivity.
Mark S. George, director of the Brain Stimulation Division, said: “This FDA clearance of the SAINT neuromodulation system for depression is really exciting news. 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 hospitalised patients, for patients who present to the emergency room, and with different schedules in clinics.”
The American Journal of Psychology published results from a double-blinded randomised controlled trial (RCT) evaluating SAINT that shows 79 per cent of people in the active treatment entered remission from their depression compared to 13 per cent in the regular treatment.
Brett Wingeier, co-founder of Magnus, said: “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 personalised 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.”
