Magnus Medical has announced that the US Food and Drug Administration (FDA) has granted the company Breakthrough Device designation for its individualised, rapid-acting, non-invasive neurostimulation technology designed to treat major depressive disorder in people who have not improved sufficiently following antidepressant medication or other treatments.
The company also announced it has raised US$25 million in Series A financing—co-led by JAZZ Venture Partners and Red Tree Venture Capital.
“We are thrilled that the FDA has recognised the novelty and potential of our therapeutic approach for major depression,” said Brett Wingeier, co-founder and CEO of Magnus. “Treatment-resistant depression causes enormous human suffering, and it is imperative to find a truly effective solution. With individualised, accelerated treatment, we will finally be able to offer people with treatment-resistant depression the ability to manage their symptoms acutely and, eventually, stay well for a lifetime.
“Moreover, we are pleased to have the support of JAZZ Venture Partners and Red Tree Venture Capital. This investment lets us further develop our technology into an integrated treatment system, and supports clinical trials to further develop individually targeted, accelerated neuromodulation for the millions of people who suffer from severe depression.”
The Magnus system is based on the SAINT technology, which was licensed exclusively to Magnus from Stanford University for commercialisation.
In an advance online article, recently published on the American Journal of Psychiatry website, results from an investigational double-blinded randomised 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 showed that 79% of people in the active treatment arm entered remission—experiencing 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.
And, 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, symptom—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, a Magnus press release notes.
“This study shows this new personalised treatment is effective and works quickly, evidenced by 79% of people entering remission after only five days of treatment,” said Brandon Bentzley, co-founder and chief science officer of Magnus, and co-first author of the study. “This is revolutionary for people suffering from acute intractable major depression, and it addresses a major unmet need in psychiatry, especially in the emergency hospital setting where effective treatment can be significantly limited.”