Magnus Medical, a therapeutic neuromodulation company, has commercially launched its SAINT neuromodulation system in the US.
The SAINT neuromodulation system is designed to be a rapid-acting remedy for treatment-resistant major depressive disorder (MDD).
It is said to offer a new form of customised neurostimulation for adults who have not shown satisfactory improvement from prior antidepressant medications.
Magnus Medical said that the SAINT therapy alters brain circuitry to enhance the treatment of MDD by modifying activity in depression-related brain networks.
The neuromodulation system has secured the breakthrough device designation and 510(k) clearance from the US Food and Drug Administration (FDA) in 2022.
To begin with, the SAINT system will be available at MUSC Health, the University of Arkansas for Medical Sciences, and California-based Acacia Clinics and Kaizen Brain Center.
Magnus Medical co-founder and chief science officer Brandon Bentzley said: “We’re more than thrilled by the successful launch of the SAINT neuromodulation system, which represents an enormous shift in the treatment landscape for clinical depression.
“This is the first step in making SAINT therapy accessible to everyone, making it possible for people who have suffered too long to reclaim their lives and find dramatic relief much more quickly.
“By offering a rapid-acting, clinically proven, highly effective treatment, SAINT has the potential to completely transform the way major depression is treated, particularly for individuals who have been ineffectively treated by prior antidepressant medications.”
The therapy uses structural and functional magnetic resonance imaging (MRI) scans to guide a proprietary algorithm. It helps in identifying the precise anatomical target for neurostimulation in individuals with MDD.
The treatment is completed within an accelerated, five-day schedule, ensuring personalised stimulation tailored to the individual’s brain connectivity, said Magnus Medical.
According to the neuromodulation company, the therapy has demonstrated its efficacy in alleviating severe depression symptoms in clinical settings.
The findings from a double-blinded randomised controlled trial revealed 79% remission of depression symptoms among participants in the active treatment group, Magnus Medical claimed.
The system is also being assessed in the Open-Label Optimisation (OLO) trial whose results are expected in 2027.
