BrainsWay Gets 3rd FDA Clearance To Help Smokers Quit

Israeli medtech company BrainsWay, which develops advanced non-invasive treatment of brain disorders, announced on Monday that it received clearance from the US Food and Drug Administration (FDA) for the company’s deep transcranial magnetic stimulation (Deep TMS) system aimed at aiding smokers in their efforts to stop smoking.

Founded in 2003, BrainsWay develops deep transcranial magnetic stimulation devices (DTMS) for non-invasive activation of deep brain structures that can cover a broad range of brain disorders.

To take part in TMS treatment, the patient sits in a chair and wears a helmet with a patented H-coil for 20 minutes while the coil performs brain stimulation with a temporary magnetic field.

TMS treatment involves wearing a helmet with a patented H-coil for about 20 minutes. The coil stimulates the brain by creating a temporary magnetic field that generates neurons deep inside the brain.

This FDA clearance “represents a significant milestone for BrainsWay,” said Christopher von Jako, Ph.D, president and CEO of the Jerusalem-based company.

“Smoking is one of the leading causes of death in the U.S. and also leads to other serious conditions, such as lung cancer and heart disease. While other therapies are currently available, a substantial medical need continues to exist for treatments that can increase the continuous quit rate among smokers. Based on the compelling data from our large, randomized pivotal study of 262 subjects, we are confident that our Deep TMS technology can play an important role in treating cigarette smokers who seek to quit,” he said.

The company hopes to execute a controlled US market release of its proprietary H4 Deep TMS coil early next year, according to von Jako.

“Importantly, this is the first FDA clearance in the addiction space for any TMS device, and it represents BrainsWay’s third FDA-cleared coil and indication, following the clearance of our H1-coil for patients suffering from major depressive disorder and the H7-coil as an adjunct therapy for the treatment of OCD.

In August 2018, the company received initial FDA approval for its non-invasive device in the treatment of obsessive-compulsive disorder (OCD), and was previously cleared in May 2018 for the treatment of Major Depressive Disorder (MDD).

“This latest clearance cements BrainsWay’s status as an industry leader, and further demonstrates our commitment to leveraging our platform technology to advance innovative therapeutic solutions across multiple patient populations,” von Jako said.