Brainsway Ltd.

BrainsWay Ltd. operates in the noninvasive neurostimulation treatment industry for mental health disorders, focusing on its proprietary Deep Transcranial Magnetic Stimulation (Deep TMS) platform technology. The company aims to improve health and transform lives by modulating brain activity through magnetic pulses, targeting hypoactive or hyperactive neuronal networks. BrainsWay is the first and only TMS company to receive FDA clearance for three distinct mental health disorder indications based on pivotal randomized placebo-controlled studies ¹. The total annual addressable market opportunity for MDD in the United States is estimated at approximately $14.6 billion ², for OCD at approximately $2.9 billion ³, and for smoking addiction at over $3.0 billion ⁴.

BrainsWay's core business model revolves around generating revenue through the sale and lease of its Deep TMS systems, as well as pay-per-use models for certain installed systems and related services. The company's primary customer segments are doctors, hospitals, and medical centers in the field of psychiatry. Revenue is also derived from extended warranty fees and variable usage fees based on the number of treatments performed. The company leverages its platform technology, which allows for the treatment of multiple indications using different H-coil helmets, to facilitate combined pricing models ⁵.

The Deep TMS platform utilizes proprietary H-Coils designed to safely stimulate deep and broad brain regions, which the company believes offers an advantage over Traditional TMS products that typically use a "figure 8" design ⁶. The system comprises a helmet with the H-Coil, a stimulator, a graphic user interface (GUI), one or more arm(s)/positioning device(s), a cooling system, and a movable medical cart ⁷. BrainsWay has developed various H-Coils for different brain regions associated with specific disorders, with some H-Coils capable of treating multiple indications ⁸. The company also developed its own proprietary stimulator, which has improved its approved Deep TMS systems through a user-friendly software interface and other features ⁹.

BrainsWay's product and service lines are primarily categorized by the indications for which its Deep TMS system is cleared. For Major Depressive Disorder (MDD), the H1 Coil received FDA clearance in 2013, with subsequent expansions including a shorter 3-minute "Theta-Burst" protocol in April 2021, a labeling expansion for anxious depression in August 2021, and an extension of clearance to the H7 Coil in August 2022 ¹⁰. In May 2024, the FDA cleared an expansion for late-life MDD patients (ages 22 to 86), and in November 2025, for adolescent patients (ages 15-21) as an adjunct therapy ¹¹. The company also obtained an expansion of its clearance in September 2025 to cover an accelerated treatment protocol for MDD ¹². For Obsessive-Compulsive Disorder (OCD), the company received marketing authorization in August 2018 as an adjunct therapy for adult patients ¹³. For smoking addiction, the Deep TMS system received FDA clearance in August 2020 as an aid in short-term smoking cessation in adults ¹⁴.

For the fiscal year ended December 31, 2025, BrainsWay reported total revenue from leasing of $12.1 million ¹⁵, revenue from sales of $35 million ¹⁶, and revenue from sale-related and other services of $5 million ¹⁷. The United States represented approximately 85% of total revenues for the year ended December 31, 2025, generating $44.2 million ¹⁸. This compares to 81% of revenues and $33.2 million in the United States for the year ended December 31, 2024 ¹⁹. The company achieved a net income of $7.5 million for the year ended December 31, 2025, compared to a net income of $2.9 million for the year ended December 31, 2024 ²⁰. As of December 31, 2025, the company had an accumulated deficit of $90.8 million ²¹. Capital expenditures for the year ended December 31, 2025, were approximately $2.3 million ²², and research and development costs amounted to $9.6 million ²³.

Year-over-year, revenue from sales increased from $22.4 million in 2024 to $35 million in 2025 ²⁴, while revenue from leasing decreased from $14.5 million in 2024 to $12.1 million in 2025 ²⁵. Revenue from sale-related and other services increased from $4.1 million in 2024 to $5 million in 2025 ²⁶. U.S. revenues increased by 33% from $33.2 million in 2024 to $44.2 million in 2025 ²⁷. The company's net income increased from $2.9 million in 2024 to $7.5 million in 2025 ²⁸.

During 2025, BrainsWay entered into several strategic transactions, including minority investments in Management Service Organizations (MSOs) and a multi-phased investment and potential acquisition agreement with Neurolief ²⁹. In August 2025, the company invested in Neurolief, an Israeli private company developing a wearable neuromodulation device for at-home treatment of mental health and neurological disorders, with an initial $5 million convertible loan ³⁰. This investment included a call option to acquire all outstanding equity interests in Neurolief ³¹. In January 2026, Neurolief's ProlivRx Neuromodulation System received PMA from the FDA as an adjunctive treatment for MDD, for use at home or in the clinic ³². BrainsWay also acquired a 4.7% stake in Stella MSO, LLC for $5 million in June 2025 ³³, and approximately 29.5% of Axis Management Company, Inc. for $2.3 million in August 2025, with an additional $1.0 million invested in March 2026 ³⁴. In October 2025, the company acquired approximately 10% of Tangient ATX Inc. for $1.5 million ³⁵. In November 2025, the FDA cleared an expansion of the company's existing MDD clearance for adolescent patients (ages 15-21) as an adjunct therapy ³⁶. In September 2025, the FDA cleared an expansion of the cleared treatment protocols for Deep TMS systems to include the SWIFT accelerated protocol for MDD ³⁷.

BrainsWay anticipates continued revenue generation primarily through sales, leases, pay-per-use fees, service fees, and other potential income from the commercial distribution of Deep TMS systems for approved indications ³⁸. The company expects capital expenditures and research and development costs to remain significant as it continues its R&D efforts and advances its existing and planned clinical pipeline in the United States and other strategic markets ³⁹. Capital expenditures and R&D costs in 2026 are expected to be financed from existing cash and cash equivalents, including proceeds from the November 5, 2024 private placement of ADSs and warrants, and ongoing sales and leases of Deep TMS systems ⁴⁰.

A major growth area for BrainsWay is the expansion of its Deep TMS platform to additional indications and technological innovations. The company is actively conducting and/or planning clinical trials in new areas, including neurological and/or addiction disorders, and is developing its next-generation multichannel device, "Deep TMS 360," which includes patented "rotational field" TMS technology ⁴¹. This technology allows for simultaneous modulation of different brain areas with independent stimulation parameters and employs two orthogonal TMS coils to induce a circularly rotating electric field, enabling stimulation of neurons in various orientations ⁴². Initial pilot data on the rotational field technology in 12 depression patients showed significantly greater improvement in depressive symptoms compared to the H7-Coil ⁴³. The company has launched a multicenter, randomized, placebo-controlled study on Alcohol Use Disorder (AUD) and several smaller feasibility studies (e.g., in OCD and post-stroke rehabilitation) involving this device ⁴⁴. The U.S. National Institutes of Health (NIH) awarded approximately $1.5 million to a research team to explore the efficacy of Deep TMS in treating substance use addictions, underscoring its potential in the broader addiction space ⁴⁵.

Another key growth area is the expansion of reimbursement coverage for Deep TMS for OCD, smoking addiction, and other future approved indications. While MDD treatment with Deep TMS is widely eligible for reimbursement, including from Medicare, the company aims to achieve similar levels of reimbursement for OCD ⁴⁶. As of March 2026, over 86 million covered lives in the U.S. are eligible for OCD coverage, with positive decisions from several major payors ⁴⁷. For smoking addiction, reimbursement is not yet available, but the Clinical TMS Society published the first coverage recommendations in October 2023, which the company is leveraging in its efforts to educate payors ⁴⁸. In December 2025, Optum Behavioral Health expanded its medical policy to include coverage for adolescents aged 15 and older with MDD ⁴⁹. In January 2026, Premera Blue Cross Blue Shield expanded coverage to include patients ages 15 and older with moderate to severe MDD treated with the accelerated SWIFT Deep TMS protocol ⁵⁰.

Operationally, the company continues to develop innovative enhancements and features for its Deep TMS systems to expand applicability and improve capabilities for approved indications ⁵¹. This includes the ongoing development and testing of the Deep TMS 360 technology, with studies initiated for Alcohol Use Disorder, post-stroke rehabilitation, and an accelerated OCD protocol ⁵². The company also plans to increase its international commercial footprint, cultivating existing distributors and exploring new strategic opportunities in markets such as Europe, Asia, Latin America, Australia, and the broader Middle East ⁵³. In Japan, commercial sales commenced in 2024 after updating guidelines to include Deep TMS coverage, and a Post Marketing Study is underway ⁵⁴.

Planned capital allocation includes continued significant investment in research and development, which amounted to $9.6 million in 2025 ⁵⁵, and capital expenditures, which were approximately $2.3 million in 2025 ⁵⁶. These investments are expected to support the development of new indications and enhancements to the Deep TMS system ⁵⁷. The company does not have current plans to pay cash dividends in the near term, intending to retain all available funds and future earnings to fund business development and growth ⁵⁸.

The company explicitly flags several structural headwinds and execution risks. Its success depends on market perception and acceptance of Deep TMS, and unfavorable reactions to TMS generally or Deep TMS specifically could negatively impact adoption ⁵⁹. Long-term growth relies on increasing market penetration and commercialization of Deep TMS, as well as developing enhancements and obtaining regulatory clearances for additional indications ⁶⁰. The company operates in a very competitive environment with numerous existing and potential competitors, including other TMS companies, pharmaceutical companies, and developers of other neuromodulation treatments ⁶¹. Failure to secure or maintain adequate coverage and reimbursement from third-party payors for current and future indications, especially given the availability of cheaper alternative TMS methods, could make physicians reluctant to use Deep TMS ⁶². The company relies on third-party suppliers for components and distributors for international markets, exposing it to supply chain disruptions and challenges in managing a dispersed network ⁶³. Clinical trials are lengthy, expensive, and have uncertain outcomes, which may delay or cause abandonment of new indication development ⁶⁴.

BrainsWay faces material risks across several categories. Geopolitical instability, including the Israel-Gaza war, Israel-Hezbollah war, and US-Israel-Iran war, has caused supply chain disruptions, increased shipping costs, and manpower challenges, particularly impacting its outsourced manufacturer near the Israel-Lebanon border ⁶⁵. The company has experienced a significant rise in the price of electronic components, exacerbated by increased demand from AI and quantum computing markets ⁶⁶. A significant portion of its revenues for the year ended December 31, 2025, were derived from a single large enterprise customer in the United States, increasing exposure to risks from changes in this customer's financial condition, purchasing patterns, or strategic priorities ⁶⁷. The company's investment in Management Service Organizations (MSOs) carries risks related to limited control over operations due to minority stakes, exposure to complex regulatory requirements like corporate practice of medicine (CPOM) laws, and potential conflicts of interest with clinics that are also its customers ⁶⁸. Product liability lawsuits and warranty claims are inherent in the medical device business, and while the company maintains insurance, coverage may be inadequate or exceeded, potentially leading to substantial uninsured liabilities ⁶⁹. The company's intellectual property, particularly its Deep TMS technology, relies on in-license agreements with government agencies and research institutions, the termination or non-compliance with which would prevent commercialization ⁷⁰. Key patents underlying Deep TMS technology are subject to the U.S. government's royalty-free usage rights on a worldwide basis, which could lead to unexpected adverse consequences on the market ⁷¹.

Management's message to shareholders emphasizes BrainsWay's position as a global leader in advanced noninvasive neurostimulation treatments, boldly advancing neuroscience with its proprietary Deep TMS platform. They highlight the company's dedication to superior science and an unparalleled body of clinical evidence, being the first and only TMS company cleared by the FDA for three separate mental health disorder indications based on pivotal randomized placebo-controlled studies ⁷². The company achieved a net income of $7.5 million for the year ended December 31, 2025, a significant improvement from a net income of $2.9 million in 2024, but acknowledges a history of operating losses and the potential for future losses, stating that existing capital and other liquidity sources are believed to be sufficient to meet capital requirements ⁷³. Strategic priorities include increasing full-scale commercialization of Deep TMS for MDD, OCD, and smoking addiction, particularly in the U.S. market, pursuing additional indications and technological innovations for Deep TMS, expanding reimbursement coverage for OCD and smoking addiction, developing innovative enhancements like the "Deep TMS 360" rotational field technology, and increasing its international commercial footprint ⁷⁴. Management also highlights strategic collaborations through synergistic transactions, such as minority investments in MSOs and the multi-phased investment and potential acquisition agreement with Neurolief, which they believe represent sound deployments of capital with the potential to accelerate patient access and increase the total addressable market ⁷⁵.