Magnus Medical, a medical device company focused on brain stimulation technology, has treated the first patients in the Open-Label Optimisation (OLO) trial of its SAINT neuromodulation system.
The OLO study is designed to evaluate the effectiveness of the Magnus neuromodulation system with SAINT technology for the treatment of major depressive disorder (MDD).
The study will enrol up to 1,000 adults with a major depressive episode, for whom prior antidepressant medication is inadequate to provide improvement, at nine clinics across the US.
In the OLO study, patients will receive ten sessions a day, comprising 10-minute treatments of SAINT therapy with 50-minute breaks for five consecutive days.
The results from the OLO study of the SAINT neuromodulation system are expected in 2027.
Magnus co-founder and chief scientific officer Brandon Bentzley said: “We are very pleased to announce the start of the OLO clinical trial with SAINT therapy for people with MDD who are ineffectively treated by prior antidepressant medications.
“Results from the previous randomized controlled trial were extremely promising—79% of participants experienced relief from their severe depression after receiving SAINT treatment. Given the enormous need for acute care in depression, we knew we needed to make SAINT treatment more widely available while building a body of clinical data.
“The OLO trial is the first time the SAINT Neuromodulation System will be studied at multiple sites, allowing a large sample size of adults suffering from clinical depression to access the rapid-acting, personalized treatment for their treatment-resistant major depression.”
Magnus neuromodulation system with SAINT Technology is the company’s first FDA-approved product, which provides a new form of personalised neurostimulation.
The neuromodulation system received FDA Breakthrough Device Designation based on its advanced, rapid-acting therapy for treatment-resistant depression.
It leverages structural and functional MRI to inform a unique algorithm that identifies the optimal anatomic brain target for neurostimulation in MDD patients.
The first patients were enrolled at Acacia Mental Health and Brain Health Solutions sites.
OLO study primary investigator David Carreon said: “SAINT therapy is the beginning of a revolution in psychiatry: fast, effective, and personalised treatments that give hope to patients who have failed to receive relief from traditional approaches.
“We have started to enrol participants and are eager to find out whether the overwhelmingly positive results seen at the initial trials at Stanford will translate to our own patients.”
OLO study primary investigator Robert Bota said: “We are delighted to have our first participants enrolled in the OLO study and happy to be working with Magnus to help provide a rapidly acting solution that may solve a fundamental problem in treating pervasive major depression.”
