This is BrainsWay’s global website. The global website is not intended for persons in the United States and includes information on clinical indications that were not cleared by the FDA, which are subject to further US regulatory review for safety and efficacy. BrainsWay D is cleared by the FDA only for patients with MDD who failed to respond to one or more anti-depressants in the current episode, and for patients with OCD as an adjunct treatment.
HACKENSACK, N.J., Nov. 28, 2016 — Brainsway® USA Inc., a subsidiary of Brainsway Ltd. (TASE:BRIN), a leader in the advanced non-invasive treatment of brain disorders, announced today promising Q3 2016 results. The report shows continuous strong financial performance and the increase is mainly due to the sale of new systems in the U.S. market.
“We continue improving our financial performance quarter over quarter towards profitability. Despite its growing investment in clinical trials, research and development, and marketing, the company managed to decrease its monthly burn rate to less than $120,000 and generate positive cash flow in Q3. Brainsway has enough cash position to execute its strategic plan,” said Hadar Levy, chief financial officer of Brainsway.
Joseph Perekupka, VP of North American Sales Operations said, “Our strategy to focus on the commercialization for the U.S. market is working and our growth exceeds our expectations during Q3 this year. We are also happy to announce that patient recruitment for our OCD trial will soon be complete. To date, the company has recruited 88 out of a total of 98 patients needed to complete the trial and are preparing to file for FDA clearance in 2017. Brainsway will strengthen its growth plans with a strong sales force and new regional sales managers. Currently, 85 percent of the American population have insurance coverage for Brainsway’s treatment while we continue to obtain clinical data and receive further positive indications in a variety of clinical trials. The company continues to seek collaborations with strategic partners and key opinion leaders in the U.S., as well as medical centers offering Deep TMS.”
Read the full release here.