This is BrainsWay’s global website. The website includes information on clinical indications that were not cleared by the FDA and are considered investigational by the U.S. medical device regulations. BrainsWay D treatment is FDA cleared for patients with MDD who failed to respond to one or more anti-depressants in the current episode.
First quarter revenues of $3.6 million represent a quarterly record and a 68% increase over first quarter 2017
Increased market demand and leasing model continue to generate sales growth
HACKENSACK, N.J., May XX, 2018 – BrainsWay Ltd. (TASE: BRIN), a leader in the advanced non-invasive treatment of brain disorders, today announced the Company’s financial results for the first quarter ended March 31, 2018, and provided a corporate update.
“Our business model, based on leasing our Deep Transcranial Magnetic Stimulation system (Deep TMS), continues to generate significant market demand and meaningful revenue growth,” said Yaacov Michlin, Chief Executive Officer of Brainsway. “As evidence of this, we reported a quarterly record $3.6 million in total revenue in the first quarter of 2018, an increase of 68% over the first quarter of 2017. Moreover, we continued to increase backlog of committed projected revenues to approximately $25 million at the end of the first quarter.”
“Early in the second quarter, we received 510(k) clearance from the FDA for our next-generation stimulator to be integrated with our Deep TMS system and we launched it with strong interest from the market during the APA conference. Moreover, we are awaiting the FDA’s response on our De Novo application to market our Deep TMS device for the treatment of obsessive compulsive disorder in the U.S. Brainsway’s current business continues to gain traction in the marketplace, while we are also focused on preparing the Company for its next stage of growth driven by clinical and technological innovation,” concluded Mr. Michlin.
First Quarter 2018 Financial Highlights
At March 31, 2018, the Company had cash, cash equivalents and short-term deposits of $15.4 million, as compared to cash, cash equivalents and short-term deposits of $16.5 million as of December 31, 2017. Brainsway’s cash use rate is approximately $1 million per quarter, with a reduction of cash burn rate to approximately $600,000 for operational expenses.
Brainsway is engaged in the research, development and sales and marketing of a medical system for non-invasive treatment of common brain disorders. The medical system developed and manufactured by the company is based on a unique and breakthrough technology called Deep TMS, which can reach the depth of the brain and produce nerve stimulation or suppression. In the US, the Company’s device is FDA cleared for the treatment of major depression (MDD), and about 90% of MDD patients are eligible for coverage (including from both private and governmental payors). The Company’s systems have also received CE clearance and are sold worldwide for the treatment of various brain disorders.