Sam Brusco, Associate Editor04.30.24
Magnus Medical has commercially rolled out its SAINT neuromodulation system, a rapid-acting therapy for treatment-resistant major depressive disorder (MDD).
The company also revealed SAINT has earned approval for a New Technology Add-on Payment (NTAP) from the Centers for Medicare & Medicaid Services (CMS). This is the first instance of CMS approving an NTAP for interventional psychiatry.
The NTAP is available for SAINT therapy’s commercial launch and is eligible for further reimbursement of up to $12,675 per hospital inpatient treatment.
Treatment using SAINT changes brain circuitry to treat MDD by modifying brain activity in brain networks that are related to depression, according to the company. The technology has earned both breakthrough status and 510(k) clearance from the U.S. Food and Drug Administration (FDA).
SAINT therapy leverages structural and functional MRI scans that inform a proprietary algorithm, which pinpoints the best anatomical target for precise neurostimulation in people with major depression. The treatment is performed on a five-day timeline, which Magnus said ensures stimulation targeting is customized to unique brain connectivity for each patient.
Magnus said it’s pursuing robust payment for SAINT therapy through Medicare in the outpatient setting and working with private insurance companies. The company expects to have selective insurance coverage in both inpatient and outpatient settings, as well as the physician’s office.
The company began its OLO clinical trial evaluating the SAINT system in July 2023.
“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, MD, 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,” Dr. Bentzley went on. “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 revealed SAINT has earned approval for a New Technology Add-on Payment (NTAP) from the Centers for Medicare & Medicaid Services (CMS). This is the first instance of CMS approving an NTAP for interventional psychiatry.
The NTAP is available for SAINT therapy’s commercial launch and is eligible for further reimbursement of up to $12,675 per hospital inpatient treatment.
Treatment using SAINT changes brain circuitry to treat MDD by modifying brain activity in brain networks that are related to depression, according to the company. The technology has earned both breakthrough status and 510(k) clearance from the U.S. Food and Drug Administration (FDA).
SAINT therapy leverages structural and functional MRI scans that inform a proprietary algorithm, which pinpoints the best anatomical target for precise neurostimulation in people with major depression. The treatment is performed on a five-day timeline, which Magnus said ensures stimulation targeting is customized to unique brain connectivity for each patient.
Magnus said it’s pursuing robust payment for SAINT therapy through Medicare in the outpatient setting and working with private insurance companies. The company expects to have selective insurance coverage in both inpatient and outpatient settings, as well as the physician’s office.
The company began its OLO clinical trial evaluating the SAINT system in July 2023.
“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, MD, 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,” Dr. Bentzley went on. “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.”