Magnus Medical, Inc., a medical device company, announced today that the US Food & Drug Administration (FDA) has granted Breakthrough Device Designation for its customized, fast-acting, non-invasive neurostimulation technology for the treatment of major depressive disorder (MDD) in people who have not gotten better from antidepressants or other treatments. The FDA’s breakthrough device program is designed to help patients gain faster access to breakthrough technologies that have the potential to provide more effective treatment or diagnosis for life-threatening or debilitating diseases or conditions than previous therapies.
The company also announced a $ 25 million Series A financing jointly led by JAZZ Venture Partners and Red Tree Venture Capital.
We are pleased that the FDA has recognized the novelty and potential of our therapeutic approach to major depression. Treatment-resistant depression causes tremendous human suffering, and finding a truly effective solution is imperative. With an individualized, accelerated treatment, we will finally offer people with therapy-resistant depression the opportunity to treat their symptoms acutely and ultimately to remain healthy for a lifetime. “
Brett Wingeier, Ph.D., Co-Founder and CEO of Magnus Medical
“We are also pleased about the support of JAZZ Venture Partners and Red Tree Venture Capital,” said Dr. Winge eggs on. “This investment enables us to develop our technology into an integrated treatment system and supports clinical studies to further develop individually targeted, accelerated neuromodulation for millions of people with major depression.”
The Magnus system is based on SAINT technology, which Stanford University has licensed exclusively to Magnus Medical for marketing.
In a preliminary online article published today on the American Journal of Psychiatry website, the results of a double-blind randomized controlled trial (RCT) investigating SAINT suggest that the novel approach has the potential to provide 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 treatment (placebo). The results of the clinical study show that 79% of patients in the active treatment arm achieved remission – that is, almost complete 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% achieved remission. In an earlier pilot study evaluating SAINT, 19 out of 21 study participants (90%) went into remission. Restoring healthy neural activity for the responders was life changing, as indicated by improvements in quality of life measurements, and within five days symptoms (including thoughts of suicide) improved dramatically. The data collected in both studies were evaluated by the FDA as part of the criteria for granting breakthrough device status.
“This study shows that this new personalized treatment is effective and fast-acting, which has been demonstrated by 79% of people who go into remission after just five days of treatment,” said Brandon Bentzley, MD, Ph.D., co-founder and CSO of Magnus Medical. and co-lead author of the study. “This is revolutionary for people with acute, intractable major depression and addresses a huge unmet need in psychiatry, particularly in the emergency hospital where effective treatment can be severely limited.”
“JAZZ has invested heavily in Magnus Medical as the company will commercialize a major breakthrough in the treatment of major depressive disorder and other mental illnesses that will transform the standard of care and the way people treat mental emergencies in hospitals and clinics,” said Andrew Firlik, MD, Managing Partner, JAZZ Venture Partners. “In addition, Magnus will bring a remarkable technology to market that will dramatically improve clinical outcomes and the quality of life for people with persistent depression.”
“We believe Magnus Medical’s innovative, accelerated, and personalized approach to mental health management has the potential to have a breakthrough impact on millions of Americans with treatment-resistant depression,” said Heath Lukatch, Ph.D., Founder and Managing Partner of Red Tree Venture Capital. “This precise, fast-acting, non-invasive neurostimulation technology addresses a critical unmet need in psychiatric illness and represents a promising, transformative solution for millions of people.”
