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BrainsWay Ltd. (NASDAQ & TASE: BWAY) is a leading global neurostimulation company headquartered in Jerusalem and the U.S., specializing in advanced noninvasive treatments for mental health disorders. With its proprietary Deep Transcranial Magnetic Stimulation (Deep TMS) technology, BrainsWay has revolutionized the field of brain disorder treatment, offering hope to millions of patients worldwide.
The company's innovative solutions target major depressive disorder (MDD), obsessive-compulsive disorder (OCD), and smoking addiction. BrainsWay's Deep TMS is FDA-cleared for its efficacy in treating these conditions. Clinical trials are ongoing for additional indications, including various psychiatric, neurological, and addiction disorders, aiming to expand the reach of this cutting-edge technology.
BrainsWay's treatments are non-invasive, safe, and convenient, typically requiring only brief daily sessions over a few weeks. This approach has already treated over 10,000 patients, delivering significant improvements without long-term side effects. The company leases and sells its Deep TMS systems, generating revenue while expanding its global footprint.
Recent collaborations, such as the partnership with Katie’s Way for providing mental health care to U.S. servicemembers, veterans, and their families, highlight BrainsWay's commitment to addressing critical mental health needs. This partnership underscores the transformative impact of Deep TMS technology in treating depression, particularly within the military community, where mental health issues are on the rise.
BrainsWay has also achieved significant milestones, such as being the first TMS company to receive three FDA-clearances for different indications, backed by pivotal clinical studies. The company's financial health is robust, with a reported 37% year-over-year revenue growth in the first quarter of 2024 and positive net income for consecutive quarters.
Looking ahead, BrainsWay continues to pursue innovations, including a clinical trial comparing accelerated Deep TMS protocols with standard treatments. This trial aims to enhance the convenience and appeal of Deep TMS, potentially broadening its market reach.
For more information about BrainsWay and its latest news, visit the company's website or follow their updates on StockTitan.
BrainsWay (NASDAQ & TASE: BWAY) announced positive pilot data from an independent Stanford University study evaluating an accelerated Deep Transcranial Magnetic Stimulation (TMS) protocol for alcohol use disorder (AUD) treatment. The study, comparing 5 patients treated with BrainsWay's H7-Coil against 39 patients receiving other treatments, showed significant improvements including:
- Lower heavy drinking days (3% vs 22%)
- Reduced regular drinking days (15% vs 28%)
- Lower relapse rates (60% vs 74%)
Following the publication, the NIH awarded $1.5 million to the research team to explore Deep TMS efficacy in treating substance use addictions. The technology is not yet FDA-cleared for AUD treatment.
BrainsWay (NASDAQ & TASE: BWAY) announced positive feasibility clinical data for their Deep TMS™ therapy in treating peripheral neuropathic pain. The double-blind, randomized crossover trial involved 17 patients who received either active Deep TMS or sham treatment for five days, followed by a nine-week washout period before switching treatments. Results demonstrated significant reduction in usual pain intensity compared to sham treatment, along with improvements in comorbid anxiety and depression symptoms. The study was published in the Neuromodulation journal, though Deep TMS is not currently FDA-cleared for neuropathic pain treatment.
BrainsWay reported strong Q3 2024 financial results with revenues of $10.5 million, representing a 26% year-over-year increase. The company achieved a gross margin of 74% and operating income of $0.3 million, compared to a loss in Q3 2023. Net income reached $0.7 million, with Adjusted EBITDA of $1.1 million. The company shipped 177 Deep TMS systems in the first nine months of 2024, up 12% from last year. Following a $20 million equity financing from Valor Equity Partners, BrainsWay raised its full-year 2024 revenue guidance to $40-41 million, projecting 25-29% growth over 2023, with expected operating income of 3-4% and Adjusted EBITDA of 10-11%.
BrainsWay (NASDAQ & TASE: BWAY), a global leader in noninvasive neurostimulation treatments for mental health disorders, has scheduled its third quarter 2024 financial results announcement for November 12, 2024, before U.S. markets open. The company will host a conference call and webcast at 8:30 AM Eastern Time to discuss results and provide business updates. The call will be accessible via multiple dial-in numbers and will be available for replay on the company's website for 30 days.
BrainsWay (NASDAQ & TASE: BWAY), a leader in noninvasive neurostimulation treatments for mental health disorders, has announced the placement of 15 new Deep Transcranial Magnetic Stimulation (Deep TMS™) systems in Taiwan and South Korea. This expansion marks a significant step in the company's penetration of the East Asian market.
CEO Hadar Levy highlighted the strategic importance of these countries in BrainsWay's international growth strategy, noting that the new orders demonstrate the company's ongoing commercial success in the region. The BrainsWay team, along with their international distribution partners, is focused on expanding global access to their innovative Deep TMS platform for both patients and healthcare providers.
BrainsWay (NASDAQ & TASE: BWAY) has announced a US$20 million private placement with Valor Equity Partners. The deal includes issuing 2,103,745 American Depositary Shares (ADSs) at US$9.51 per ADS, a 20% premium over the 30-day VWAP, and warrants to purchase up to 1,500,000 additional ADSs. If fully exercised, the warrants could increase total proceeds to US$34.3 million.
Valor will gain board representation and BrainsWay will use the funds for strategic initiatives including expanding market awareness, enhancing data analysis capabilities, developing R&D roadmap, and expanding access to Deep TMS™ technology. The transaction is subject to shareholder approval and customary closing conditions.
BrainsWay (NASDAQ & TASE: BWAY), a leader in noninvasive neurostimulation treatments for mental health disorders, has announced a significant expansion on the U.S. East Coast. A large and growing enterprise network has placed an order for 14 new Deep TMS™ systems, following other recent multisystem orders. This expansion aligns with BrainsWay's strategic goal of fostering relationships with various mental health groups and networks to drive long-term profitable growth.
CEO Hadar Levy expressed satisfaction with the company's continued expansion and support for the growth of this large enterprise network. As of June 30, 2024, BrainsWay had an installed base of 1,215 Deep TMS systems, solidifying its position as a preferred choice for many mental health providers.
BrainsWay (NASDAQ & TASE: BWAY) has received approval from the Israel Ministry of Defense's Rehabilitation Department for reimbursement of Deep TMS™ therapy for qualifying PTSD patients at Israeli public hospitals. This decision comes in response to growing concerns about PTSD in Israel, especially following recent conflicts. CEO Hadar Levy emphasized the importance of addressing this expanding patient population.
A recent study estimates that over 5% of Israel's population could develop PTSD. Additionally, a retrospective cohort study of 99 military veterans showed significant symptom reductions after Deep TMS treatment: 44.1% for PTSD, 43.5% for depression, and 54% for suicidal ideation at six-month follow-up. BrainsWay aims to expand reimbursement to more medical centers and private clinics in Israel.
BrainsWay (NASDAQ & TASE: BWAY), a leader in noninvasive neurostimulation treatments for mental health disorders, has appointed Richard A. Bermudes, M.D. as Chief Medical Officer (CMO), effective September 1, 2024. Dr. Bermudes, with over 20 years of experience in brain stimulation therapies, is considered a preeminent clinician in the TMS field. He replaces Dr. Aron Tendler, who will continue collaborating on strategic research projects.
Dr. Bermudes brings extensive experience as a practicing physician, researcher, and entrepreneur. He co-founded a behavioral health care network with 24 outpatient clinics, pioneered new therapies, and launched successful telehealth programs. He is also an Associate Physician at UC Davis Department of Psychiatry and Behavioral Sciences and the lead editor of a renowned book on Transcranial Magnetic Stimulation.
BrainsWay (NASDAQ & TASE: BWAY) reported strong Q2 2024 financial results, with 28% year-over-year revenue growth to $10 million. The company achieved positive net income for the third consecutive quarter and positive Adjusted EBITDA for the fourth consecutive quarter. Key highlights include:
- Gross margin increased to 75% from 73% in Q2 2023
- Operating income of $0.6 million, compared to a $1.3 million loss in Q2 2023
- Net income of $0.6 million, compared to a $1.7 million loss in Q2 2023
- Adjusted EBITDA of $1.2 million, compared to a $0.6 million loss in Q2 2023
- Cash and equivalents of $48.1 million as of June 30, 2024
BrainsWay raised its full-year 2024 revenue guidance to $38.5-$40 million, representing 21-25% growth over 2023. The company expects continued profitability and positive cash generation in H2 2024.
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