Neuronetics gets FDA clearance for NeuroStar add-on in OCD

Transcranial magnetic stimulation pioneer Neuronetics has picked up a new FDA clearance that builds its position in obsessive-compulsive disorder (OCD), a major new application of the technology.

Neuronetics was the first company to get FDA authorization for a transcranial magnetic stimulation (TMS) therapy for treatment-resistant depression back in 2008, and since then has extended use of its NeuroStar device with a green light for major depressive disorder (MDD) in 2017 and as an adjunctive therapy for OCD in 2022.

TMS treatment involves the use of focused magnetic pulses to stimulate neurons in the brain and has become an important additional option for patients who can’t get relief from talking therapies, medication or both.

The new clearance is for Neuronetics’ OCD MT Cap, an add-on coil device that speeds up the process used to prepare the patient for treatment with the NeuroStar system. It is used to locate the motor threshold (MT), a measurement used to determine the amount of energy that needs to be delivered for treatment.

Using MT Cap, clinicians identify the location of the motor cortex by observing when the patient’s hand or fingertips move and then dial down the dose until that no longer occurs. That’s the MT and sets the dose that will be used for treatment when applied to the prefrontal cortex.

When combined with Neuronetics’ Fast MT algorithm it can reduce NeuroStar setup times—which can take up to half an hour for each patient—by around 40%, improving efficiency of clinics offering the therapy.

Neuronetics’ MDD MT-Cap was approved for use in depression toward the end of 2021, and the new version makes NeuroStar the only TMS system with coil placement assistance technologies for both depression and OCD, according to a company statement.

The market for TMS systems is getting more crowded, with competitors in the depression area including Mag & More, Brainsway, Neuroprex, Neurosoft, Magstim, Magventure, Neurostar and Nexstim. In OCD, Neuronetics has far fewer rivals—Brainsway’s system was first to market and remains the only other TMS approved for this use.

Neuronetics says around 300 OCD patients have been treated with NeuroStar, with over 6,000 treatments delivered. That’s a fraction of the more than 150,000 patients treated with the TMS for depression, but there is a big potential OCD population to go after of around 4 million adults in the U.S.

OCD MT-Cap will launch this month with full rollout across the U.S. expected before the end of the year.

In the first quarter, Neuronetics shipped 49 NeuroStar systems, bringing in $3.9 million in revenues, with treatment sessions adding another $10.6 million to the total.

The company is also developing NeuroStar for bipolar depression, getting breakthrough device status for that use from the FDA in 2020.