BURLINGAME, Calif.– Magnus Medical, Inc., a pioneering therapeutic neuromodulation company transforming the treatment of neuropsychiatric disorders, today announced the commercial launch of the SAINT® neuromodulation system, a groundbreaking, rapid-acting therapy for treatment-resistant major depressive disorder (MDD).
Treatment with SAINT changes a person’s brain circuitry to treat MDD more effectively by modifying activity in brain networks that are related to depression. Granted Breakthrough Device Designation and 510(k) clearance by the U.S. Food & Drug Administration (FDA), SAINT 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 Laura B. Dunn, M.D., chair, 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.
“With our interventional psychiatry program, Helen L. Porter and James T. Dyke Brain Imaging Research Center, and our inpatient and outpatient treatment programs all housed under one roof, our teams of mental health experts will work seamlessly together to implement the SAINT protocol, tailored to each patient’s individual needs,” continued Dr. Dunn. “We are excited to bring the future of brain science directly to the people of Arkansas and the entire region.”
SAINT therapy works by leveraging structural and functional magnetic resonance imaging (MRI) scans to inform a proprietary algorithm that pinpoints the optimal anatomical target for precise neurostimulation in individuals with major depression. The innovative treatment is performed on an accelerated, five-day timeline, ensuring that stimulation targeting is meticulously 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,” said Brandon Bentzley, M.D., Ph.D., co-founder and CSO of Magnus Medical, who was also trained by Dr. George at MUSC, the birthplace of clinical TMS for the treatment of neuropsychiatric disorders. “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 company also announced that it received approval for a New Technology Add-on Payment (NTAP) from the Centers for Medicare & Medicaid Services (CMS) for its SAINT neuromodulation system. 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 (AMA) issued new Category III Current Procedural Terminology (CPT) codes for targeted, accelerated iTBS for depression, encompassing the SAINT neuromodulation system, effective July 1, 2024. The company is actively pursuing robust payment for SAINT therapy through Medicare in the hospital outpatient setting and working directly with private insurance companies. Magnus Medical expects to have selective insurance coverage in both the hospital inpatient and outpatient setting and the physician’s office. The company anticipates that coverage will grow over the next several years.
Major Depressive Disorder, or MDD, is an episodic disorder that can last months or years.1 Treatment-resistant MDD is a condition that impacts over 50% of people with depression who don’t respond to medications and psychotherapy.2 In the U.S., 20% of adults experience depression at some point in their lives,3 which amounts to approximately 52 million people out of 260 million adults.4 Research shows that 10.4% of adults experience MDD within a 12-month period and 20.6% over their lifetime.5 Considering the total adult population, this means an estimated 26 million Americans struggle with depression each year.
