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Brainsway Ltd. - BWAY STOCK NEWS

Welcome to our dedicated page for Brainsway Ltd. news (Ticker: BWAY), a resource for investors and traders seeking the latest updates and insights on Brainsway Ltd. stock.

Overview of BrainsWay Ltd

BrainsWay Ltd (BWAY) is a pioneering global company specializing in advanced noninvasive neurostimulation treatments for brain disorders. With its headquarters located both in Jerusalem and the United States, the company has established a robust international presence and a growing portfolio of clinical evidence that supports its innovative approach to treating mental health conditions.

Innovative Technology and Core Business

At the heart of BrainsWay's offering is its proprietary Deep Transcranial Magnetic Stimulation (Deep TMS) platform technology. This breakthrough device delivers non-invasive magnetic pulses that stimulate neural circuits, offering a novel therapeutic alternative for patients who are inadequately served by traditional pharmacological treatments. The technology is designed to address a range of indications such as major depressive disorder, including anxious depression, obsessive-compulsive disorder, and smoking addiction. The Deep TMS system is engineered to be safe and convenient, requiring only brief daily sessions over a few weeks, thereby providing an accessible treatment option with minimal systemic or long-term side effects.

Clinical Validation and Industry Impact

BrainsWay's technology has been the subject of extensive research and multiple clinical trials, yielding pivotal data that supports its efficacy. The company’s approach not only addresses mental health conditions with rigorous clinical backing but also underscores the company’s commitment to advancing neurostimulation science. By integrating advanced coil designs and sophisticated software protocols, BrainsWay's Deep TMS offers targeted stimulation of specific brain regions. This precision in treatment delivery has established a new therapeutic paradigm in neuropsychiatry, especially for patients who have not responded optimally to medication.

Market Position and Revenue Model

BrainsWay operates at the intersection of medical device innovation and clinical neuroscience. The company generates revenue primarily through the sale and leasing of its Deep TMS systems to hospitals, mental health clinics, and research institutions worldwide. Its business model is reinforced by a series of strategic regulatory clearances, including several indications approved by the FDA, which not only validate the safety and efficacy of its technology but also serve as powerful market differentiators.

Global Reach and Expansion Strategy

With installations across multiple continents, including North America, Europe, and South America, BrainsWay has positioned itself as a key player in the global neurostimulation market. The company’s consistent focus on clinical excellence and technological innovation has bolstered its international footprint, making its life-changing therapy accessible to a diverse patient population. Its growth strategy emphasizes expanding its geographical presence and strengthening ties with healthcare providers, who are increasingly seeking alternatives to traditional treatment modalities.

Operational Excellence and Evidence-Based Approach

BrainsWay’s operational strategy is deeply rooted in rigorous scientific research and evidence-based medicine. Every aspect of its Deep TMS technology—from the design of its coils to the delivery protocols—has been optimized through clinical trials and post-market studies. The company’s transparent communication of clinical outcomes, patient benefits, and operational milestones reinforces its reputation for reliability and safety. BrainsWay provides clear, factual insights into the mechanics of its therapies, addressing both the technical and human elements of treatment, which is crucial in building trust with patients, practitioners, and investors alike.

Key Differentiators in the Competitive Landscape

In an industry marked by rapid innovation and evolving treatment paradigms, BrainsWay distinguishes itself through a blend of superior science, a strong clinical evidence base, and a commitment to patient-centric solutions. Unlike many conventional treatment methods, Deep TMS provides a non-invasive, well-tolerated, and efficient treatment alternative without the risks associated with invasive procedures. Furthermore, the company’s strategic focus on conditions with high unmet medical need sets it apart from competitors, cementing its role as an expert facilitator in advancing therapeutic outcomes for mental health disorders.

Operational and Strategic Highlights

  • Noninvasive Approach: The Deep TMS system offers a modern and patient-friendly alternative to invasive neurosurgical procedures, reducing both operational risk and recovery time.
  • Robust Clinical Evidence: The technology is supported by an extensive array of clinical studies that document significant improvements in symptomatology among patients with major depressive disorder, OCD, and smoking addiction.
  • Global Installations: With a growing number of installed systems around the world, BrainsWay has proven its ability to meet diverse market needs while contributing to improved patient outcomes on a global scale.
  • Revenue Generation: Through the leasing and sale of its Deep TMS systems to healthcare facilities and mental health centers, the company maintains a stable commercial base built on proven clinical benefits.

Understanding the Scientific and Clinical Rationale

The application of magnetic stimulation to the brain is based on sound neuroscience principles. Deep TMS targets specific neural networks associated with mood regulation and behavior, offering a precision-based treatment that can be finely tuned to individual patient needs. This meticulous approach to neurostimulation is a cornerstone of BrainsWay’s operational philosophy, ensuring that every treatment session is both clinically meaningful and scientifically substantiated.

Conclusion

BrainsWay Ltd stands as a beacon of innovation in the field of noninvasive neurostimulation, combining advanced technology with rigorous clinical science to offer effective treatment options for complex brain disorders. Its comprehensive approach—from state-of-the-art device design to extensive clinical validations—underscores the company’s authority and trustworthiness within the medical community. For anyone seeking a deep understanding of modern neuromodulation technologies and their applications in mental health treatments, BrainsWay represents a remarkable convergence of cutting-edge science, clinical precision, and a patient-focused operational model.

Rhea-AI Summary

BrainsWay (NASDAQ & TASE: BWAY) reported strong financial results for Q4 and full year 2024. The company achieved record quarterly sales of $11.4 million in Q4 2024, up 27% from Q4 2023, and full-year revenue of $41 million, representing a 29% year-over-year increase.

Q4 highlights include shipping 75 Deep TMS™ systems (25% increase), maintaining a 75% gross margin, and achieving operating income of $0.4 million. Full-year 2024 showed operating income of $1.4 million, compared to a $5.0 million loss in 2023, with net income of $2.9 million.

The company secured a $20 million strategic equity financing from Valor Equity Partners and ended 2024 with $69.4 million in cash. For 2025, BrainsWay projects revenue between $49-51 million (20-24% growth) with operating income of 3-4% and Adjusted EBITDA of 11-12%.

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BrainsWay (NASDAQ & TASE: BWAY), a global leader in advanced noninvasive neurostimulation treatments for mental health disorders, has announced its upcoming virtual presentation at the Oppenheimer 35th Annual Healthcare MedTech & Services Conference.

The presentation is scheduled for March 18, 2025, at 9:20 AM EST. Investors and interested parties can access the live webcast through the Events & News – Presentations section of BrainsWay's Investor Relations website. A replay of the presentation will remain available for 30 days after the broadcast. Individual meetings with management can be arranged through Oppenheimer & Co representatives.

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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.

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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.

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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.

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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%.

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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.

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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.

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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.

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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.

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FAQ

What is the current stock price of Brainsway Ltd. (BWAY)?

The current stock price of Brainsway Ltd. (BWAY) is $8.85 as of April 4, 2025.

What is the market cap of Brainsway Ltd. (BWAY)?

The market cap of Brainsway Ltd. (BWAY) is approximately 166.2M.

What is the core technology behind BrainsWay Ltd?

BrainsWay utilizes its proprietary Deep Transcranial Magnetic Stimulation (Deep TMS) technology, a noninvasive method that stimulates neural circuits to alleviate brain disorders such as major depressive disorder, OCD, and smoking addiction.

How does BrainsWay generate its revenue?

The company earns revenue primarily through the sale and leasing of its Deep TMS systems to hospital networks, clinical centers, and research facilities worldwide.

Which mental health conditions does BrainsWay target with its technology?

BrainsWay’s Deep TMS technology is indicated for major depressive disorder (including anxious depression), obsessive-compulsive disorder, and smoking addiction, with ongoing clinical trials exploring additional psychiatric and neurological applications.

What makes Deep TMS different from other brain stimulation therapies?

Unlike invasive procedures, Deep TMS is a noninvasive treatment that is both safe and convenient, offering targeted stimulation of neural networks with minimal side effects, which makes it a compelling alternative for patients unresponsive to traditional therapies.

How is BrainsWay positioned within the neurostimulation market?

BrainsWay is recognized for its robust clinical evidence, innovative technology, and global reach. Its regulatory clearances and focus on high unmet medical needs distinguish it in a competitive field of neuromodulation treatment providers.

What evidence supports the efficacy of BrainsWay's technology?

The company’s numerous clinical trials and pivotal studies have demonstrated significant improvements in patient symptomatology for various conditions, reinforcing the clinical efficacy and safety profile of the Deep TMS system.
Brainsway Ltd.

Nasdaq:BWAY

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166.24M
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6.42%
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0.29%
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