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BrainsWay Ltd. reports developments in noninvasive neurostimulation treatments for mental health disorders. The company markets its proprietary Deep TMS platform, with FDA-cleared indications that include major depressive disorder, obsessive-compulsive disorder, and smoking addiction, and derives revenue from leases and sales of Deep TMS systems.
Recurring updates include financial results, operating guidance, system placements, reimbursement and payer coverage for TMS therapy, clinical data for Deep TMS protocols such as SWIFT, and additional regulatory clearances. Company news also covers strategic minority-stake and milestone-based investments in mental health providers and related neurostimulation technologies, along with investor conference participation and operational updates across its U.S. and Israel-based business.
BrainsWay has launched a new clinical trial to evaluate an accelerated treatment protocol for its Deep Transcranial Magnetic Stimulation (Deep TMS) system, targeting major depressive disorder (MDD). This multicenter, randomized, controlled trial will compare a novel accelerated protocol to the FDA-cleared standard-of-care protocol. Over 100 patients will participate, with one group receiving an acute treatment phase over several days and the other over several weeks. The trial aims to determine if the accelerated protocol is as effective as the traditional method. Recruitment is ongoing across multiple U.S. sites.
BrainsWay has announced that the FDA has expanded the indication for its Deep Transcranial Magnetic Stimulation system (Deep TMS™) to treat major depressive disorder (MDD) in patients aged 22 to 86, extending beyond the previous age limit of 68. This marks the company's 10th FDA clearance, making their Deep TMS the only TMS device approved for depression treatment in patients over 68. The expanded labeling is supported by clinical data showing significant response and remission rates in older patients. BrainsWay sees this as a promising business opportunity, given the rising life expectancy and the need for effective depression treatments in the elderly.
BrainsWay reported a 37% year-over-year revenue growth in Q1 2024, achieving positive net income for the second consecutive quarter. The company also recorded positive Adjusted EBITDA and cash flow from operations for the third consecutive quarter. Revenues reached $9.1 million, with a gross margin of 75%. Operating income was $0.1 million compared to a loss of $3.7 million in the same period last year. Net income was $0.1 million, an improvement from a net loss of $2.4 million in Q1 2023. The Company's cash, cash equivalents, and short-term deposits stood at $47.8 million as of March 31, 2024. BrainsWay shipped 57 Deep TMS™ systems in Q1 2024, bringing the total installed base to 1,158 systems. Collaboration with partner Katie’s Way Plus expanded, and the Company installed its 11th Deep TMS system in Israel. With strong Q1 results, BrainsWay reaffirmed its full-year 2024 revenue guidance of $37 million to $40 million, expecting continued growth and profitability throughout the year.
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