magnus medical saint.Magnus Medical this week announced the commercial launch of its Saint neuromodulation system for treatment-resistant major depressive disorder (MDD).

The Saint treatment changes a patient’s brain circuitry to treat MDD more effectively. It modifies activity in brain networks that are related to depression.

Saint won FDA breakthrough device designation and has FDA 510(k) clearance. According to the company, the therapy has led to dramatic improvements in people’s symptoms of severe depression in a clinical setting.

“We are thrilled to be the first site in the nation to offer the breakthrough, FDA-cleared Saint neuromodulation system for individuals suffering from depression, and I am very optimistic that this new approach will change people’s lives,” said Dr. Laura Dunn, chair of the Department of Psychiatry and director of the Psychiatric Research Institute at the University of Arkansas for Medical Sciences. “The innovative Saint protocol provides neuroscience-based, targeted, personalized, non-invasive rapid treatment for patients with one of the most disabling psychiatric conditions – major depression. As a practicing psychiatrist, I know firsthand how important it is for patients to have new options to help them get their lives back. At the UAMS Psychiatric Research Institute, our mission is to provide outstanding, expert-driven psychiatric care for our patients.”

Magnus Medical’s Saint therapy leverages structural and functional magnetic resonance imaging (MRI) scans to inform a proprietary algorithm that pinpoints the optimal anatomical target for precise neurostimulation in people with major depression. The treatment is performed over a five-day timeline to ensure that stimulation is customized to each person’s unique brain connectivity.

“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,” Co-Founder and Chief Medical Officer Dr. Brandon Bentzley said in a news release. “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.”

New CMS designation with the launch

Magnus Medical also announced receiving approval for a New Technology Add-On Payment (NTAP) from the Centers for Medicare and Medicaid Services (CMS). According to the company, this is the first time CMS has approved an NTAP for Interventional Psychiatry. The NTAP is available for the commercial launch of the Saint therapy and is eligible for additional reimbursement of up to $12,675 per hospital inpatient treatment.

The American Medical Association also issued new Category III Current Procedural Terminology (CPT) codes for targeted, accelerated iTBS for depression, effective July 1, 2024. Magnus Medical is pursuing robust payment for Saint therapy through Medicare in the hospital outpatient setting and is working directly with private insurance companies.

It expects to have selective insurance coverage in hospital inpatients and outpatient settings and the physician’s office. The company also anticipates coverage to grow over several years.