The US Food and Drug Administration (FDA) has granted Breakthrough Device Designation to Magnus Medical’s neurostimulation technology for the treatment of major depressive disorder (MDD).

Developed based on the SAINT technology, the new, non-invasive Magnus System acts rapidly and is designed to treat MDD in people who have not sufficiently recovered after receiving antidepressant medication or other therapies.

Magnus Medical has exclusively licensed the SAINT technology from Stanford University for commercialisation.

According to an investigational randomised controlled trial (RCT) published on the American Journal of Psychiatry website, the individually targeted neurostimulation technology relieved severe depression in 79% of people who received active treatment.

Magnus Medical co-founder and CSO Brandon Bentzley said: “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.

“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.”

Additionally, the company has raised $25m in a Series A financing round, which was co-led by JAZZ Venture Partners and Red Tree Venture Capital.

JAZZ Venture Partners managing partner Andrew Firlik said: “JAZZ eagerly invested in Magnus Medical because the company will commercialise a major breakthrough in the treatment of major depressive disorder and other mental health illnesses that will change the standard of care and reshape how people are treated for mental health emergencies in hospitals and clinics.”

Furthermore, Magnus Medical is anticipated to receive 501(k) clearance for the Magnus System from the US FDA in the future.