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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 Ltd. (NASDAQ: BWAY) has appointed Dr. Zafiris Daskalakis to its scientific advisory board, enhancing its expertise in brain stimulation. Dr. Daskalakis, Chair of Psychiatry at UCSD, brings extensive research knowledge and over 450 publications in neurophysiology and psychiatric disorders. This strategic addition aims to strengthen BrainsWay’s growth and clinical impact as it seeks to expand the application of its Deep TMS™ technology for mental health treatment. CEO Christopher von Jako emphasized the importance of Dr. Daskalakis’s insights in navigating the company's future.

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BrainsWay Ltd. (NASDAQ: BWAY) has released promising data from a pivotal clinical trial published in World Psychiatry, supporting its Deep TMS™ treatment for smoking addiction. Conducted across 12 U.S. and 2 Israeli sites with 262 chronic smokers, the trial showed over 25% of patients achieving a minimum of 4 weeks of abstinence. The treatment, which is FDA-cleared, demonstrated significant reductions in smoking behavior. BrainsWay is engaged in a controlled market release to refine its business model and gather post-marketing data.

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BURLINGTON, Mass. and JERUSALEM, Sept. 09, 2021 – BrainsWay (NASDAQ: BWAY) announced that CEO Christopher von Jako will present at two investment conferences in September. The first is the Oppenheimer & Co. Fall Healthcare Life Sciences & Medtech Virtual Summit from September 20-23, with a presentation on September 22 at 3:45 PM ET. The second is the Cantor Fitzgerald Global Healthcare Conference from September 27-30, with a presentation on September 27 at 3:20 PM ET. Investors can arrange meetings with management during these events.

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BURLINGTON, Mass. and JERUSALEM, Aug. 30, 2021 – BrainsWay (NASDAQ & TASE: BWAY), a leader in noninvasive neurostimulation for mental health, will have its CEO, Christopher von Jako, present and hold investor meetings at the H.C. Wainwright 23rd Annual Global Investment Conference on September 13, 2021. The company is recognized for its Deep TMS™ technology, with three FDA-clearances for major depressive disorder, obsessive-compulsive disorder, and smoking addiction. With ongoing clinical trials, BrainsWay aims to expand global access to its innovative treatments.

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BrainsWay Ltd. announced on August 18, 2021, that it received 510(k) clearance from the FDA for its Deep Transcranial Magnetic Stimulation (Deep TMS™) System. This allows BrainsWay to market its system for reducing anxiety symptoms in adults with depression, enhancing its existing depression indication. The company presented data from 573 patients across 11 studies, showing clinically meaningful treatment effects. This clearance broadens its reach in the mental health market, potentially impacting millions suffering from anxious depression, as 60-90% of depressed patients exhibit anxiety symptoms.

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BrainsWay Ltd. reported a strong Q2 2021 performance, achieving total revenues of $7.0 million, a 45% increase year-over-year. The installed base of Deep TMS™ systems rose to 682, marking a 20% growth. The company is gaining traction in OCD reimbursement, with key coverage policies from Centene and HCSC impacting 42 million covered lives. Operating loss was $1.5 million, up from $215 thousand in Q2 2020, while cash reserves increased to $55.9 million.

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BrainsWay Ltd. (NASDAQ: BWAY) announced it will report its second quarter 2021 financial results and operational highlights on August 11, 2021, before U.S. markets open. A conference call will follow at 8:30 AM ET to discuss these results and business updates. BrainsWay is recognized for its advanced noninvasive neurostimulation treatments for mental health disorders, utilizing its proprietary Deep TMS™ technology. The company has achieved FDA clearance for three indications, including major depressive disorder, and continues expanding clinical trials for additional disorders.

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On July 13, 2021, MindPath Care Centers announced an open house on July 15 to showcase BrainsWay’s Deep Transcranial Magnetic Stimulation (Deep TMS) treatment for major depressive disorder (MDD) and obsessive-compulsive disorder (OCD) in Charlotte, NC. The event will allow local mental health clinicians to witness live demonstrations of the Deep TMS device, which administers magnetic waves via a helmet. It is FDA-cleared for MDD since 2013 and OCD since 2018. Patients can return to normal activities post-treatment, enhancing access to care for those with treatment-resistant conditions.

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BrainsWay Ltd. (NASDAQ: BWAY) announced that Christopher von Jako, Ph.D., President and CEO, will present at the Ladenburg Thalmann 2021 Healthcare Conference on July 14, 2021, at 2:30 PM ET. The company will also facilitate one-on-one investor meetings during the conference. BrainsWay specializes in advanced noninvasive neurostimulation treatments for mental health disorders and is recognized for its FDA-cleared indications including major depressive disorder and obsessive-compulsive disorder.

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BrainsWay (NASDAQ: BWAY), a leader in noninvasive neurostimulation, announced CEO Christopher von Jako will present at the Raymond James Human Health Innovation Conference on June 21, 2021, at 10:00 AM ET. The event will include one-on-one investor meetings. BrainsWay is recognized for its proprietary Deep TMS technology, with FDA clearance for major depressive disorder, obsessive-compulsive disorder, and smoking addiction. The company aims to expand awareness and access to its innovative treatments, leveraging clinical evidence to advance mental health care.

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FAQ

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

The current stock price of Brainsway Ltd. (BWAY) is $8.46 as of April 11, 2025.

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

The market cap of Brainsway Ltd. (BWAY) is approximately 153.6M.

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.

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