BrainsWay’s so-called depression helmet—which focuses powerful electromagnetic waves to stimulate and help rewire neurons firing deep within the brain—picked up its second clearance from the FDA last August, making it the first noninvasive device for obsessive-compulsive disorder.
First approved for treatment-resistant depression in 2013, the system was reconfigured for OCD to target separate regions of the brain's cortex. With the new arrangement of magnetic coils, BrainsWay’s deep transcranial magnetic stimulation system showed it could deliver significant improvements in OCD symptoms after six weeks of treatment. In a sham-controlled trial of 100 patients, 38% saw their OCD symptom scores decline by more than 30%.
But to the Jerusalem-based device company, the FDA’s de novo clearance offers more than an entree into a market more than 2 million patients strong in the U.S.; it’s also a validation of BrainsWay’s Deep TMS technology as a platform for additional in-office psychiatric treatments, alongside medication and psychotherapy.
In December 2018, the company was selected to participate in an FDA innovation challenge, with the goal of developing its device as a treatment for opioid use disorder. Under the program, BrainsWay will work with the agency to conduct a clinical study and expedite a potential marketing application.
The company is also conducting trials for FDA clearance in smoking cessation and post-traumatic stress disorder, which have already received CE marks. BrainsWay also boasts international approvals in chronic pain, autism, bipolar disorder and schizophrenia, as well as Alzheimer’s and Parkinson’s diseases.
By the end of last year, BrainsWay said, the company had shipped 57 OCD coils to new clinics or as upgrades for its existing customers. Its total installed base of 383 Deep TMS systems in 2018 represented a 47% increase year over year, mirrored by a 47% increase in revenues for the year, to $16.4 million.
This year, BrainsWay decided to pursue an IPO on the Nasdaq. In January, the company disclosed plans to raise $30 million through the public offering, but in mid-April, that amount was downsized to about $27.5 million and priced at $11 per share under the symbol BWAY. The company is already listed on the Tel Aviv Stock Exchange.