The SAINT neuromodulation system provides a new form of individualised neurostimulation therapy for treatment-resistant major depression in adults. Credit: Magnus Medical, Inc./Business Wire.

Magnus Medical has announced the commercial launch of its SAINT neuromodulation system in the US, a new therapy designed to treat individuals with treatment-resistant major depressive disorder (MDD).

The system has received breakthrough device designation and 510(k) clearance from the US Food and Drug Administration (FDA).

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Treatment with SAINT can change a person’s brain circuitry in the treatment of MDD effectively by modifying brain network activity related to depression.

SAINT therapy utilises structural and functional magnetic resonance imaging (MRI) scans to inform an algorithm that identifies an optimal anatomical target for precise neurostimulation in people with major depression.

The treatment is performed over an accelerated timeline of five days, with customised stimulation targeting for each person’s unique brain connectivity.

Magnus Medical co-founder and chief scientific 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.

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“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 revealed that the Centers for Medicare & Medicaid Services (CMS) approved a new technology add-on payment (NTAP) for the SAINT neuromodulation system.

This marks the first NTAP approval for interventional psychiatry, allowing for additional reimbursement of up to $12,675 per hospital inpatient treatment.

Furthermore, the American Medical Association has issued new Category III Current Procedural Terminology (CPT) codes for targeted, accelerated iTBS for depression, which includes the SAINT neuromodulation system, set to take effect from 1 July 2024.

MDD is an episodic disorder that can persist for months or years. More than half of the individuals with depression do not respond to medications and psychotherapy.