Brainsway Ltd. Stock Price, News & Analysis

BrainsWay Ltd. (NASDAQ & TASE: BWAY) is a medical technology company focused on advanced noninvasive neurostimulation treatments for mental health disorders. According to the company, it is advancing neuroscience through its proprietary Deep Transcranial Magnetic Stimulation (Deep TMS™) platform technology, with the goal of improving health and transforming lives. BrainsWay states that it is the first and only TMS company to obtain three FDA-cleared indications backed by pivotal clinical studies demonstrating clinically proven efficacy, with current indications that include major depressive disorder (including reduction of anxiety symptoms, commonly referred to as anxious depression), obsessive-compulsive disorder, and smoking addiction.

BrainsWay operates in the surgical and medical instrument manufacturing industry within the broader manufacturing sector. The company develops and commercializes Deep TMS systems that deliver noninvasive brain stimulation in clinical settings. BrainsWay reports that it derives revenues from the lease and sale of Deep TMS systems, positioning these systems as tools for mental health providers who treat patients with depression, OCD, and smoking addiction. The company emphasizes that its Deep TMS platform is supported by a substantial body of clinical research and that additional clinical trials in various psychiatric, neurological, and addiction disorders are underway.

Deep TMS™ platform and clinical indications

BrainsWay describes Deep TMS as a noninvasive, in-office brain stimulation treatment that uses magnetic fields to activate neural networks in the brain to improve symptoms of certain mental health and addiction conditions. The company highlights that its Deep TMS system is FDA cleared for:

• Treatment of depressive episodes in adults with major depressive disorder who have failed to achieve satisfactory improvement from previous antidepressant medication treatment in the current episode, including decreasing comorbid anxiety symptoms.
• Treatment of major depressive disorder in adolescents aged 15 to 21 years as an adjunct therapy.
• Treatment of obsessive-compulsive disorder.
• Treatment of smoking addiction.

BrainsWay notes that its Deep TMS system is indicated for decreasing anxiety symptoms in adults with MDD who may exhibit comorbid anxiety. The company also reports that it has obtained FDA clearance for an accelerated Deep TMS protocol for the noninvasive treatment of major depressive disorder, including patients with comorbid anxiety symptoms. This accelerated protocol, based on clinical data from a multicenter, randomized, blinded, controlled study, is described as requiring significantly fewer clinic visits than the standard protocol while demonstrating comparable outcomes in depression score improvement, response, and remission.

Technology features: H-coil and Deep TMS 360™

BrainsWay emphasizes its proprietary H-coil technology, which is used in its Deep TMS devices to stimulate targeted brain regions. The company states that it continues to lead the field with this technology, supported by robust clinical research and collaboration with providers and policymakers. BrainsWay has also introduced its Deep TMS 360™ system, described as a next-generation multichannel TMS platform designed to provide more comprehensive and uniform stimulation of neurons in targeted brain regions. According to the company, the multichannel architecture of Deep TMS 360 may be particularly suited for complex clinical populations, such as individuals with chronic alcohol use disorder, where cortical atrophy can make it more difficult to achieve desired stimulation levels.

BrainsWay reports that it has launched a multicenter, randomized, controlled clinical trial to investigate the use of Deep TMS 360 in individuals with Alcohol Use Disorder (AUD). The trial is designed to evaluate whether the system can reduce heavy drinking and cravings, and is being conducted at research sites in multiple U.S. states as well as international locations in Israel and Sweden. The company notes that this is the first multicenter clinical trial utilizing its multichannel TMS platform and views it as a major milestone in advancing its innovation pipeline.

Clinical research and pipeline

BrainsWay repeatedly underscores its focus on evidence-based neuromodulation. The company states that it is dedicated to leading through superior science and building on an extensive clinical evidence base. It highlights:

• Pivotal clinical studies supporting its three FDA-cleared indications (MDD, OCD, and smoking addiction).
• Additional clinical trials of Deep TMS in a range of psychiatric, neurological, and addiction disorders that are underway.
• Large real-world data sets, including one of the largest adolescent neuromodulation data sets submitted to the U.S. FDA, which supported the label expansion for adolescent MDD.
• NIH-funded research, including a multimillion-dollar grant to a leading U.S. research team at Stanford University and the Palo Alto Veterans Institute for Research to study accelerated Deep TMS protocols for Alcohol Use Disorder, and prior NIH support for studies in stimulant use disorder.

Through these initiatives, BrainsWay positions Deep TMS as a non-drug treatment option for patients who have not achieved adequate relief with traditional pharmacological approaches. The company’s communications emphasize the unmet need in conditions such as major depressive disorder and substance use disorders, and the potential role of noninvasive neuromodulation in addressing these gaps.

Business model and revenue generation

BrainsWay states that it derives revenues from the lease and sale of Deep TMS systems. In its financial disclosures, the company notes that a significant portion of recent customer engagements are structured as multi-year lease agreements, and that it has accumulated remaining performance obligations from customers under multi-year contracts. BrainsWay reports shipping Deep TMS systems to mental health providers and building an installed base of systems used in clinics for in-office treatment of patients with depression, OCD, and smoking addiction.

In addition to its core Deep TMS business, BrainsWay has disclosed strategic minority equity investments in mental health providers and neuromodulation companies. For example, the company has made a strategic investment in Neurolief, a neuromodulation company that has developed Proliv™Rx, a wearable, noninvasive, multi-channel brain neuromodulation system designed for at-home or in-clinic use in adults with major depressive disorder who have failed at least one antidepressant medication. BrainsWay’s investment in Neurolief includes an option to acquire the company. BrainsWay has also reported minority-stake investments in mental health provider organizations, with the stated goal of expanding its presence across the mental health treatment ecosystem and supporting awareness and adoption of Deep TMS therapies.

Regulatory milestones and payer coverage

BrainsWay’s recent communications highlight several regulatory and reimbursement-related developments:

• FDA clearance of an accelerated Deep TMS protocol for major depressive disorder, including patients with comorbid anxiety symptoms.
• FDA clearance expanding the Deep TMS label to include adolescent patients aged 15 to 21 with major depressive disorder as an adjunct therapy.
• Coverage policy expansions by insurers for Deep TMS depression therapy, including coverage for adolescents aged 15 and older and coverage for BrainsWay’s SWIFT™ (Short-course with Intrinsic Field Targeting) accelerated Deep TMS protocol for patients with moderate to severe MDD.
• Recognition by payers and regulators of Deep TMS as a noninvasive, clinically proven treatment option for depression, including treatment-resistant cases.

These developments are presented by the company as steps toward broader access to Deep TMS therapy across age groups and clinical settings. BrainsWay also notes that it collaborates with providers and policymakers to expand access to advanced neurostimulation therapies and to align reimbursement policies with new treatment protocols.

Geographic footprint and corporate background

BrainsWay states that it was founded in 2003 and has operations in the United States and Israel. The company is a foreign private issuer that files reports with the U.S. Securities and Exchange Commission on Form 20-F and Form 6-K, and its ordinary shares trade on both the NASDAQ and the Tel Aviv Stock Exchange (TASE) under the symbol BWAY. Its SEC filings list its principal executive office in Jerusalem, Israel.

BrainsWay’s disclosures emphasize its commitment to increasing global awareness of and access to Deep TMS. The company communicates regularly through press releases, investor presentations, and SEC filings, covering topics such as financial results, clinical research updates, regulatory clearances, payer coverage decisions, and strategic investments.

Position within the medical device and mental health sectors

Within the surgical and medical instrument manufacturing industry, BrainsWay focuses specifically on noninvasive brain stimulation devices for mental health and addiction-related conditions. Its Deep TMS systems are used by mental health clinics and providers as in-office treatments, and its strategic investment in Neurolief connects it to at-home neuromodulation solutions. The company’s communications describe a long-term vision of integrating multiple treatment modalities across multiple care settings, using data-driven and technology-enabled approaches to mental health care.

BrainsWay’s ongoing clinical trials in psychiatric, neurological, and addiction disorders, along with NIH-supported research in Alcohol Use Disorder and stimulant use disorders, suggest a pipeline that extends beyond its currently cleared indications. At the same time, the company’s financial reports emphasize multi-year customer agreements and an installed base of Deep TMS systems as key components of its commercial model.

BrainsWay stock (BWAY) on Stock Titan

On Stock Titan, the BWAY stock overview page provides investors and researchers with a centralized view of BrainsWay’s business focus on Deep TMS technology, its FDA-cleared indications for major depressive disorder, obsessive-compulsive disorder, and smoking addiction, and its role in the mental health treatment landscape. Users can review how the company describes its technology, regulatory milestones, clinical research, and strategic investments, alongside market data and regulatory filings. This context can help investors evaluate BrainsWay within the medical device and mental health sectors, using only information that the company has publicly disclosed.