BURLINGTON, Mass. and JERUSALEM - BrainsWay Ltd. (NASDAQ & TASE: BWAY), a company specializing in noninvasive neurostimulation treatments for mental health disorders, has announced its market entry into Canada with the signing of an exclusive distribution agreement. The contract, with a specialty distributor that operates across various clinical sectors, mandates minimum yearly orders, starting with 11 Deep Transcranial Magnetic Stimulation (Deep TMS) systems for 2024.
Deep TMS is a treatment modality that uses magnetic fields to stimulate neural networks in the brain associated with mental health conditions. The patented technology involves a helmet-like device that houses a coil design to deliver the treatment. In Canada, Deep TMS is approved for treating major depressive disorder (MDD) and obsessive-compulsive disorder (OCD).
Hadar Levy, CEO of BrainsWay, expressed enthusiasm about the company's expansion into the Canadian healthcare market, highlighting the significant mental health challenges faced in the country. Levy cited statistics indicating that by age 40, one in two Canadians have or have had a mental illness and that adequate care for major depressive episodes is not received by half of those affected.
MDD is a widespread and severe form of depression, affecting millions worldwide, with the World Health Organization (WHO) reporting approximately 264 million people globally. The condition often presents with anxiety, known as anxious depression, which includes symptoms such as nervousness, panic, and insomnia. The economic impact of MDD in the United States alone was estimated at $326 billion prior to the COVID-19 pandemic.
OCD, characterized by repetitive thoughts and behaviors, is another condition that Deep TMS targets. It is a chronic disorder with a significant impact on quality of life and economic burden, with an estimated cost of over $10.6 billion annually in the U.S. healthcare system.
BrainsWay, with offices in Massachusetts and Israel, is recognized for its Deep TMS platform technology and is the first TMS company with three FDA-cleared indications backed by pivotal clinical studies. The company is engaged in ongoing clinical trials for various psychiatric, neurological, and addiction disorders.
This expansion into Canada represents a significant step for BrainsWay in its mission to improve health outcomes and access to neurostimulation treatments. The information for this article is based on a press release statement from BrainsWay Ltd.
In other recent news, BrainsWay Ltd. has been making significant strides in both its medical treatments and financial growth. The FDA has expanded the age range for BrainsWay's Deep Transcranial Magnetic Stimulation (Deep TMS) system, now allowing it to be administered to patients aged 22 to 86 with major depressive disorder.
This is a significant development, as it marks the first time a TMS treatment has been indicated for patients over 68, and it's the 10th FDA approval for BrainsWay.
On the financial front, BrainsWay reported a robust 37% year-over-year revenue increase in the first quarter of 2024, marking positive net income for the second consecutive quarter. The company also saw a rise in its gross margin by nearly 200 basis points compared to the previous year. Furthermore, 57 Deep TMS systems were shipped in the first quarter, contributing to the company's strong financial position.
BrainsWay has confirmed its revenue guidance for the full year 2024 to be between $37 million and $40 million, indicating a growth of 16% to 26% from the previous year's revenue. The company is also planning to increase its presence both domestically and internationally, with expansion plans in the U.S., far East, Korea, Taiwan, and India.
InvestingPro Insights
As BrainsWay Ltd. (NASDAQ & TASE: BWAY) forges ahead with its expansion into the Canadian market, investors might be keen to understand the financial health and performance metrics of the company. BrainsWay's strategic move to distribute Deep Transcranial Magnetic Stimulation systems in Canada aligns with the company's growth trajectory, despite analysts not expecting profitability this year. With a market capitalization of approximately $103.53 million and a notable revenue growth of 32.61% in the last twelve months as of Q1 2024, BrainsWay is demonstrating a strong capacity for scaling its operations.
Investors should note that BrainsWay has managed a high return over the last year, with a one-year price total return of 174.51%. This impressive figure could be indicative of the market's confidence in the company's innovative approach to mental health treatment. Additionally, BrainsWay holds more cash than debt on its balance sheet, and its liquid assets exceed short-term obligations, providing the company with a solid financial cushion to support its business initiatives.
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While BrainsWay does not pay a dividend to shareholders, the company's strong return over the last month, at 13.94%, and the significant revenue growth, suggest potential for capital appreciation. These metrics, coupled with the company's strategic initiatives, may be of interest to investors looking for growth opportunities within the healthcare technology sector.
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