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About BrainsWay Ltd. (BWAY)
BrainsWay Ltd. is a global leader in the field of non-invasive neurostimulation, dedicated to advancing mental health care through its proprietary Deep Transcranial Magnetic Stimulation (Deep TMS™) technology. With headquarters in Jerusalem, Israel, and Burlington, Massachusetts, BrainsWay leverages cutting-edge neuroscience to provide innovative solutions for psychiatric, neurological, and addiction disorders. The company's mission is to improve health and transform lives by offering safe, effective, and clinically validated treatments for conditions that have historically been challenging to manage.
Core Technology and FDA-Cleared Indications
BrainsWay’s Deep TMS platform utilizes a patented coil design to deliver targeted magnetic pulses to specific brain regions involved in mental health disorders. This technology is the first and only TMS system to receive FDA clearance for three distinct indications: major depressive disorder (MDD), obsessive-compulsive disorder (OCD), and smoking addiction. The system has also demonstrated efficacy in reducing anxiety symptoms associated with depression, commonly referred to as anxious depression.
Unlike traditional TMS, which offers more superficial stimulation, Deep TMS is designed to penetrate deeper and broader brain regions, making it particularly effective for patients who may not respond to other treatments. The therapy is non-invasive, requires no anesthesia, and is free from systemic side effects, making it a highly convenient option for patients. Treatment protocols typically involve brief daily sessions over several weeks, followed by maintenance phases as needed.
Business Model and Revenue Streams
BrainsWay generates revenue through the sale and leasing of its Deep TMS systems to mental health care providers, hospitals, and clinics worldwide. Additionally, the company benefits from recurring revenue streams through the sale of consumables and maintenance services associated with its systems. This hybrid model ensures both upfront and long-term revenue generation, supporting the company’s growth and operational sustainability.
Clinical Efficacy and Ongoing Research
BrainsWay’s commitment to advancing mental health care is underscored by its robust clinical research program. The company has conducted numerous clinical trials demonstrating the efficacy of Deep TMS in treating a wide range of conditions, including MDD, OCD, and smoking addiction. Recent studies have also explored its potential applications in late-life depression, Parkinson’s disease, and substance use disorders such as alcohol addiction. These efforts aim to expand the indications for Deep TMS, further solidifying its position as a transformative treatment option in mental health care.
Market Context and Competitive Landscape
The global mental health crisis, exacerbated by rising rates of depression, anxiety, and addiction, has created a significant demand for effective, non-invasive treatment options. BrainsWay addresses this unmet need by offering a scientifically validated alternative to traditional pharmacological therapies, which often come with limited efficacy and adverse side effects. Within the competitive landscape, BrainsWay differentiates itself through its patented Deep TMS technology, extensive clinical evidence, and global reach. The company’s focus on underserved populations, such as older adults and veterans, further enhances its market appeal.
Global Reach and Strategic Partnerships
BrainsWay’s international presence spans North America, Europe, South America, and the Middle East, reflecting its commitment to increasing global access to advanced mental health care. The company has established strategic partnerships with mental health networks, hospitals, and specialized care providers, enabling it to expand the reach of its Deep TMS systems. Notable collaborations include initiatives to address the unique mental health challenges faced by veterans and military personnel, as well as efforts to make treatment accessible in underserved regions.
Future Outlook
With ongoing clinical trials, a growing portfolio of FDA-cleared indications, and a strong commitment to innovation, BrainsWay is well-positioned to lead the neurostimulation market. The company’s focus on addressing critical mental health challenges, combined with its scalable business model and global footprint, underscores its potential to transform the landscape of mental health care.
Conclusion
BrainsWay Ltd. represents a unique convergence of advanced neuroscience, innovative technology, and a mission-driven approach to improving mental health. By offering safe, effective, and non-invasive treatment options, the company is redefining the standard of care for mental health disorders and paving the way for a healthier future.
BrainsWay (NASDAQ & TASE: BWAY), a global leader in advanced noninvasive neurostimulation treatments for mental health disorders, announced it will report its fourth quarter and full year 2024 financial results on March 11, 2025, before the U.S. financial markets open.
The company will also provide operational highlights during the announcement. A conference call and webcast will be held at 8:30 AM Eastern Time to discuss these results and provide a business update. The live broadcast will be available on the company's website and will remain accessible for replay for 30 days.
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.
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