The FDA granted de novo clearance to the first noninvasive device treatment for obsessive compulsive disorder, Brainsway’s transcranial magnetic stimulation system, adding a new therapy for adults alongside medication and psychotherapy.
The marketing authorization is the second for Brainsway’s deep TMS device in the U.S., after being cleared for treatment-resistant major depressive disorder in 2013. The Jerusalem-based company intends to begin installing the OCD treatment in clinics immediately, as an upgrade to its current systems as well as through new installations.
“With more than two million U.S. adults suffering from OCD, this clearance provides us with a significant market opportunity,” Brainsway President and CEO Yaacov Michlin said in a statement.
“Importantly, this clearance further establishes Deep TMS as a platform technology that will provide treatments for additional psychiatric indications, subject to successful completion of our currently ongoing multi center studies and regulatory approvals,” Michlin said.
Brainsway’s treatment has received CE marks for multiple disorders by stimulating nerve cells in different regions of the brain, including in chronic pain, autism, bipolar disorder, schizophrenia and others, as well as for Alzheimer’s and Parkinson’s diseases.
For OCD, the FDA reviewed data from a randomized sham study of 100 patients, with those already receiving OCD treatments maintaining their current doses.
“The brain region targeted with the BrainsWay H7- coil is the anterior cingulate cortex, a region known for many years to be centrally implicated in the pathophysiology of OCD,” said Brainsway scientific founder Abraham Zangen, professor of neuroscience and chair of the psychobiology brain program at the Ben-Gurion University of the Negev in Beersheba, Israel. “This Deep TMS H7-coil is different from the BrainsWay H1-coil used for treating depression that targets primarily the lateral pre-frontal cortex.”
Using an OCD severity score, the study showed 38% of patients responded to the Brainsway device with greater than 30% reductions in severity—compared to 11% of patients that responded to the device when switched to a sham setting, which produces the same amount of noise and sensation but without the magnetic stimulation.