FDA’s Breakthrough Device Designation for rapid-acting technology to treat major depression

Non-invasive neurostimulation technology to rapidly treat major depressive disorder (MDD) 

The FDA has awarded Breakthrough Device Designation to Magnus Medical’s non-invasive technology to rapidly treat major depressive disorder (MDD) in adults who have not responded to existing treatments. The Magnus System is based on the SAINT technology (Stanford Accelerated Intelligent Neuromodulation Therapy), a form of transcranial magnetic stimulation which was licensed exclusively to Magnus Medical from Stanford University for commercialization.

An advance online article published in the American Journal of Psychiatry, describe the results from an investigational double-blinded randomized controlled trial (RCT) evaluating SAINT suggest that the novel approach has the potential to be a reproducible, rapid, and highly effective treatment for severe, refractory depression in a broader clinical setting. Fourteen study participants received active treatment, and another 15 received sham (placebo) treatment. The clinical trial results show that 79% of people in the active treatment arm entered remission—that is, experienced near elimination of their depression symptoms based on the Montgomery-Åsberg Depression Rating Scale (MADRS)—compared to people in the sham treatment arm, where only 13% entered remission. In an earlier pilot trial evaluating SAINT, 19 of 21 study participants (90%) entered remission. The restoration of healthy neural activity for the responders was life-changing as indicated by improvement in quality of life measures, and within five days, symptoms (including thoughts of suicide) improved dramatically. Data collected during both studies were evaluated by the FDA as part of the criteria for granting Breakthrough Device designation. 

The SAINT technology is described as having breakthrough algorithms that can identify optimal, personalized targets to affect brain circuitry based on structural and functional neuroimaging. Therefore, utilizing precise patterns of stimulation that can leverage recent advances in neuroscience and restore these neural circuits.

According to Magnus Medical, this system is a novel innovation with the potential to have a significant positive impact on the treatment of severe depression. For the first time, advanced imaging technologies combined with personalized neural targeting and novel stimulation patterns have the potential to yield a new form of individualized, non-invasive neurostimulation for people with treatment-resistant depression. This new approach is designed to be delivered on an accelerated timeline and is precisely tailored to each person’s brain connectivity.

The Magnus System, currently an investigational device, is expected to require 501(k) clearance from the U.S. FDA and is not yet commercially available.

Sources:

Cole EJ, Phillips AL, Bentzley BS, et al. Stanford Neuromodulation Therapy (SNT): A Double-Blind Randomized Controlled Trial. AJP Published Online:29 Oct 2021

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