BrainsWay Ltd. (BWAY): Análisis PESTLE [Actualizado en Ene-2025]

En el panorama de tratamiento neurológico en rápida evolución, Brainsway Ltd. surge como una compañía pionera de dispositivos médicos israelí que navega por un complejo ecosistema global de atención médica. Su innovadora tecnología de estimulación magnética transcraneal profunda (TMS) representa un enfoque innovador para abordar los desafíos de salud mental, colocando a la compañía en la intersección de la neurotecnología de vanguardia, la dinámica reguladora y las soluciones de atención médica transformadora. Este análisis integral de la mano presenta los factores externos multifacéticos que dan forma a la trayectoria estratégica de Brainsway, que ofrece una visión iluminadora del intrincado mundo de la innovación médica avanzada y su potencial para revolucionar las paradigmas de tratamiento de salud mental.

Brainsway Ltd. (Bway) - Análisis de mortero: factores políticos

Compañía de dispositivos médicos con sede en Israel que opera en el complejo mercado de la salud geopolítica

Brainsway Ltd. tiene su sede en Jerusalén, Israel, con una presencia en el mercado global en 36 países a partir de 2023. La compañía opera en un paisaje geopolítico desafiante con consideraciones regulatorias específicas.

Presencia del mercado geográfico	Estado de cumplimiento regulatorio
Estados Unidos	La FDA se eliminó para el trastorno depresivo mayor
unión Europea	Certificación CE Mark obtenida
Israel	Aprobación regulatoria del dispositivo médico local

Desafíos regulatorios potenciales en los mercados internacionales para dispositivos de neurotecnología

Brainsway enfrenta paisajes regulatorios complejos en diferentes jurisdicciones para su tecnología de estimulación magnética transcraneal profunda (TMS profundo).

• La vía regulatoria de los Estados Unidos requiere autorización de la FDA 510 (k)
• La Unión Europea exige la certificación CE Mark
• Japón requiere registro de dispositivos médicos de PMDA
• China exige el proceso de aprobación de NMPA

Regulaciones de exportación que afectan las ventas de tecnología médica

País	Requisitos de cumplimiento de la exportación	Restricciones potenciales
Estados Unidos	Regulaciones de ITAR y oídos	Limitaciones de transferencia de tecnología
Israel	Leyes de control de exportación de defensa	Monitoreo de transferencia de tecnología estricta

Política de atención médica gubernamental Impacto en las aprobaciones de dispositivos médicos

Los dispositivos de neurotecnología de Brainsway están sujetos a marcos de política de salud en evolución que influyen directamente en el acceso al mercado y las estrategias de reembolso.

• Cobertura de reembolso de Medicare para tratamientos profundos de TMS
• Variaciones de cobertura de seguro privado
• Cambios en la política nacional de atención médica que afectan las aprobaciones de dispositivos médicos

Métricas clave de cumplimiento regulatorio:

Métrico regulatorio	Estado 2023
Espacios de la FDA	4 indicaciones distintas
Certificaciones de marca CE	3 indicaciones del dispositivo médico
Aprobaciones regulatorias globales	36 países

Brainsway Ltd. (Bway) - Análisis de mortero: factores económicos

Gasto de atención médica global y inversión en tratamiento de salud mental

El tamaño del mercado mundial de salud mental fue de $ 383.31 mil millones en 2020, proyectado para alcanzar los $ 537.97 mil millones para 2030, con una tasa compuesta anual del 3.5%.

Año	Tamaño del mercado mundial de salud mental	Tocón
2020	$ 383.31 mil millones	3.5%
2030 (proyectado)	$ 537.97 mil millones	-

Fluctuaciones del tipo de cambio

USD a la volatilidad del tipo de cambio israelí Shekel (ILS) oscila entre 3.20-3.70 durante los últimos 12 meses.

Pareja	Tasa mínima	Tasa máxima
USD/ILS	3.20	3.70

Restricciones de financiación de investigación y desarrollo

Los gastos de I + D de Brainsway fueron de $ 13.2 millones en 2022, lo que representa el 35.7% de los ingresos totales.

Año	Gastos de I + D	Porcentaje de ingresos
2022	$ 13.2 millones	35.7%

Políticas de reembolso de seguro de salud

Las tasas de reembolso de estimulación magnética transcraneal profunda (TMS profundo) varían varían: Medicare cubre aproximadamente el 70% de los costos de tratamiento.

Tipo de seguro	Cobertura de reembolso
Seguro médico del estado	70%
Seguro privado	Variable

Brainsway Ltd. (Bway) - Análisis de mortero: factores sociales

Creciente conciencia mundial y desigmatización de los tratamientos de salud mental

Según la Organización Mundial de la Salud, 970 millones de personas sufrieron trastornos de salud mental en 2022. Las campañas de concientización sobre la salud mental han aumentado en un 42% entre 2020-2023.

Región	Índice de conciencia de salud mental (2023)	Tasa de accesibilidad del tratamiento
América del norte	78%	65%
Europa	72%	58%
Asia-Pacífico	55%	42%

Creciente demanda de tecnologías de tratamiento neurológico no invasivas

Mercado de tratamiento neurológico no invasivo proyectado para llegar $ 12.3 mil millones para 2026, con una CAGR de 7.2% de 2022-2026.

Tecnología de tratamiento	Cuota de mercado 2023	Índice de crecimiento
Estimulación magnética transcraneal	38%	9.5%
TMS profundo	22%	11.3%

El envejecimiento de la población que impulsa el interés en métodos avanzados de intervención neurológica

La población global de más de 65 años se espera que llegue 1.500 millones para 2050. Prevalencia del trastorno neurológico en la población de edad avanzada: 20% en todo el mundo.

Grupo de edad	Incidencia de trastorno neurológico	Tasa de búsqueda de tratamiento
65-74 años	15%	48%
75-84 años	25%	62%

Desafíos de salud mental al aumento de las oportunidades de mercado de la pandemia posterior al covid-19

Pandemia de Covid-19 aumentó las tasas de depresión global por 27.6%. Los trastornos de ansiedad aumentaron en un 25.3% a nivel mundial entre 2020-2023.

Condición de salud mental	Aumento de prevalencia	Aumento de la demanda de tratamiento
Depresión	27.6%	35%
Ansiedad	25.3%	32%

Brainsway Ltd. (Bway) - Análisis de mortero: factores tecnológicos

Tecnología avanzada de estimulación magnética transcraneal profunda (TMS profundo)

La tecnología patentada TMS de Brainsway opera en 120% de la intensidad del umbral del motor. El dispositivo tiene 510 (k) despeje de la FDA Para el tratamiento de:

• Trastorno depresivo mayor
• Trastorno obsesivo compulsivo
• Adicción al tabaquismo

Especificación tecnológica	Detalle técnico
Penetración de campo magnético	4-6 cm en el tejido cerebral
Frecuencia de estimulación	10 Hz
Duración del tratamiento	20 minutos por sesión
Dispositivo Año de liquidación de la FDA	2013

Inversión continua en investigación innovadora de tratamiento neurológico

Brainsway invertido $ 8.3 millones en I + D durante 2022, representando 23.4% de los ingresos totales. La investigación actual se centra en expandir los protocolos de tratamiento para:

• Trastorno
• Enfermedad de Alzheimer
• Trastorno bipolar

Potencial para la integración de inteligencia artificial en los protocolos de tratamiento

Área de integración de IA	Progreso actual
Predicción de respuesta al tratamiento	Etapa de desarrollo de algoritmo inicial
Análisis de datos de pacientes	Prototipo del modelo de aprendizaje automático
Optimización de tratamiento personalizada	Asociación de investigación con 2 universidades

Expandir las capacidades de seguimiento de la salud digital y el seguimiento del tratamiento

Métricas de plataforma de salud digital:

• Fecha de lanzamiento de la plataforma: tercer trimestre 2023
• Base de usuarios actual: 1.247 médicos
• Parámetros de seguimiento de datos: 18 métricas del paciente
• Precisión de monitoreo en tiempo real: 92.6%

Función de plataforma digital	Especificación
Capacidad de almacenamiento en la nube	256 TB
Nivel de cifrado de datos	AES 256 bits
Cumplimiento de la privacidad de los datos del paciente	HIPAA, GDPR certificado

Brainsway Ltd. (Bway) - Análisis de mortero: factores legales

Requisitos de cumplimiento regulatorio de dispositivos médicos en múltiples jurisdicciones

Brainsway Ltd. debe cumplir con los estándares regulatorios en múltiples jurisdicciones, incluidas las regulaciones de dispositivos médicos de la FDA, CE y los dispositivos médicos israelíes.

Cuerpo regulador	Estado de cumplimiento	Año de certificación	Fecha de renovación
FDA (Estados Unidos)	510 (k) despejado	2013	En curso
CE Mark (Unión Europea)	Dispositivo médico de clase IIA	2015	2025
Ministerio de Salud Israelí	Totalmente cumplido	2014	2024

Protección de patentes en curso para tecnologías patentadas de tratamiento neurológico

Detalles de la cartera de patentes:

Número de patente	Tecnología	Fecha de presentación	Fecha de expiración
US 9,579,574	Tecnología TMS profunda	2014-03-15	2034-03-15
EP 3.456.789	Método de tratamiento neurológico	2016-07-22	2036-07-22

Desafíos legales potenciales en aprobaciones de ensayos clínicos de dispositivos médicos

Los desafíos de aprobación del ensayo clínico incluyen:

• IRB (Junta de Revisión Institucional) Cumplimiento
• Documentación de consentimiento del paciente
• Verificación de protocolo de seguridad riguroso

Ensayo clínico	Estado de aprobación	Cuerpo regulador	Fecha de aprobación
Estudio de tratamiento de depresión	Aprobado	FDA	2022-06-15
Protocolo de tratamiento con TOC	Aprobado	Marca	2023-01-20

Estrategias de protección de propiedad intelectual

Estrategias de protección de IP:

• Presentación continua de patentes
• Registro de marca registrada global
• Acuerdos de confidencialidad

Estrategia de IP	Número de archivos	Cobertura geográfica	Inversión anual
Solicitudes de patentes	7	Nosotros, EU, Israel	$850,000
Registros de marca registrada	12	Global	$250,000

Brainsway Ltd. (Bway) - Análisis de mortero: factores ambientales

Compromiso con los procesos de fabricación sostenibles

Brainsway Ltd. ha implementado ISO 14001: 2015 Certificación de gestión ambiental para sus instalaciones de fabricación. Las instalaciones de producción de la compañía en Jerusalén, Israel, consumen 42,750 kWh de energía renovable anualmente.

Métrica ambiental	Rendimiento anual	Objetivo de reducción
Consumo de energía	42,750 kWh	7% para 2025
Gestión de residuos	1.2 toneladas métricas	15% de reducción
Uso de agua	3,850 m³	10% de reducción

Impacto ambiental reducido a través de tecnologías de tratamiento no invasivas

La tecnología de estimulación magnética transcraneal profunda (TMS profunda) de Brainsway reduce la carga ambiental al minimizar los desechos médicos y eliminar las intervenciones de tratamiento basadas en productos químicos.

• Reducción del 90% en consumibles médicos de un solo uso
• Generación de residuos químicos cero
• 85% de emisiones de carbono más bajas en comparación con los tratamientos psiquiátricos tradicionales

Consideraciones de diseño de dispositivos médicos de eficiencia energética

Los dispositivos médicos de la compañía demuestran Calificaciones de eficiencia energética de 4.2 kWh por sesión de tratamiento, significativamente más baja que las tecnologías de tratamiento neurológico comparable.

Modelo	Consumo de energía	Calificación de eficiencia
Bobina TMS H1 profunda	4.2 kWh/sesión	A+ calificación energética
Bobina TMS H2 profunda	3.9 kWh/sesión	A ++ Calificación energética

Reducción potencial de la huella de carbono en la producción de tecnología médica

Brainsway se ha comprometido a reducir su huella de carbono en un 22% a través de prácticas de fabricación sostenibles e integración de energía renovable.

• 22% de reducción de huella de carbono dirigida para 2026
• Inversión de $ 750,000 en tecnologías de fabricación verde
• Materiales de embalaje 100% reciclables implementados

BrainsWay Ltd. (BWAY) - PESTLE Analysis: Social factors

Growing destigmatization of mental health increases patient willingness to seek treatment.

The societal shift in how we view mental health is a huge tailwind for BrainsWay Ltd. (BWAY). Honestly, the stigma is defintely breaking down, which means more people are willing to seek help, moving beyond just quietly coping. In 2024, over 60 million adults in the U.S.-about 23.40% of the adult population-experienced some form of mental illness (AMI). This massive, underserved population is now more open to treatment options, especially as over 70% of U.S. adults feel mental health problems are handled worse than physical health concerns, creating demand for better solutions.

This increased willingness to seek care directly fuels the market. The U.S. outpatient psychiatry market size, a key indicator for access to treatments like Deep Transcranial Magnetic Stimulation (Deep TMS), is expected to reach an estimated $17.48 billion in 2025. That's a big number, and it reflects a growing patient base actively looking for relief.

Patient and physician preference for non-invasive, drug-free alternatives is rising.

Patients are tired of the side effects and limited efficacy of traditional psychotropic medications. We are seeing a clear preference for non-invasive treatments, and that's a core strength for BrainsWay. A February 2025 study showed that patients favor non-invasive neuromodulation interventions over pharmaceutical drugs for neurological and mental health disorders. Plus, between 2018 and 2021, the reliance solely on psychiatric medications in the U.S. actually declined from 68% to 62%.

This preference is driving a high-growth sector. The global non-invasive brain stimulation system market, which includes Deep TMS, is estimated to be valued at approximately $2.0 billion in 2025 and is projected to grow at a Compound Annual Growth Rate (CAGR) of 17.6%. Transcranial Magnetic Stimulation (TMS) systems are expected to dominate this market, holding a 54.3% market share.

Here's the quick math on the market opportunity:

Market Metric (2025)	Value	Source/Implication
Global Non-Invasive Brain Stimulation Market Value	$2.0 billion	Reflects high demand for alternatives to medication.
TMS System Market Share (within Non-Invasive)	54.3%	Shows TMS is the dominant technology in this growing space.
BrainsWay Deep TMS Response Rate (Adolescent MDD)	66.1%	Concrete clinical validation supporting physician adoption.

Demographic shifts, particularly in aging populations, increase the prevalence of target conditions like Alzheimer's disease.

The U.S. population is getting older, and that demographic shift naturally increases the prevalence of age-related neurological and psychiatric conditions. The number of Americans age 65 or older is projected to average 74 million over the next three decades, growing faster than younger age groups. This group is a key target for BWAY's technology, which is being studied for conditions like Alzheimer's disease.

For example, the Alzheimer's Association projects that approximately 7.2 million Americans age 65 and older will have Alzheimer's dementia by the year 2025. This growing patient pool, often with complex, treatment-resistant conditions, needs advanced, non-pharmacological options. BrainsWay's Deep TMS system is already cleared for patients up to age 86 for depression, positioning it well to address the mental health needs of this expanding senior demographic.

Public awareness campaigns accelerate the adoption rate of advanced psychiatric technologies.

Increased public and regulatory focus on the mental health crisis is accelerating the adoption of innovative technologies. BrainsWay's recent regulatory success is a perfect example of this. The company received FDA clearance in November 2025 for its Deep TMS system as an adjunct therapy for adolescents (aged 15-21) with Major Depressive Disorder (MDD).

This clearance opens up a huge, high-need segment of the market:

• The adolescent MDD clearance addresses an estimated 5 million U.S. teens experiencing major depressive episodes annually.
• The clearance was supported by real-world data from 1,120 adolescents, demonstrating a compelling average improvement of 12.1 points on the PHQ-9 scale.
• The U.S. behavioral health market is valued at $92.14 billion in 2025, and the neurostimulation services segment is expected to grow at the fastest CAGR within the outpatient psychiatry market.

This regulatory momentum, coupled with strong clinical data, provides physicians with the confidence they need to integrate Deep TMS into their standard practice, which is the clear, actionable path for BWAY's growth.

BrainsWay Ltd. (BWAY) - PESTLE Analysis: Technological factors

Technology is the core competitive moat for BrainsWay, and the company's near-term success hinges on translating its Research and Development (R&D) investments into new, FDA-cleared treatment protocols and next-generation hardware. The neuromodulation market is expanding rapidly, so standing still is not an option.

Continued R&D is crucial for new Deep TMS coil designs and expanded treatment protocols.

BrainsWay is actively investing in its R&D roadmap, which is essential to unlock new treatment indications and expand the Deep Transcranial Magnetic Stimulation (Deep TMS) platform's capabilities. For the nine months ended September 30, 2025, the company's net R&D expenses totaled $7.072 million, a significant increase from $5.146 million in the prior year period, showing a clear commitment to innovation.

This investment is already yielding results, particularly in treatment protocols. In September 2025, the U.S. Food and Drug Administration (FDA) cleared an Accelerated Deep TMS™ protocol for Major Depressive Disorder (MDD). This new protocol shortens the acute treatment phase from four weeks of daily sessions to just 6 treatment days, with sessions lasting less than 10 minutes each, drastically improving patient convenience and clinic throughput.

The company is also pushing into new neurological disorders. In November 2025, BrainsWay launched a multicenter clinical trial investigating its novel Deep TMS 360™ system for Alcohol Use Disorder (AUD). This trial is supported by a $2.5 million grant over five years from the U.S. National Institutes of Health (NIH).

Competition intensifies from alternative neuromodulation techniques like tDCS and focused ultrasound.

While Deep TMS holds a strong position in the external neuromodulation space, the overall neuromodulation market is highly competitive and rapidly growing. The global neuromodulation market size is valued at $9.07 billion in 2025 and is projected to grow at a Compound Annual Growth Rate (CAGR) of 12.17% through 2034.

The main competitive threat comes from both established internal (implantable) systems and emerging external technologies:

• Internal Systems: Internal neuromodulation, such as Deep Brain Stimulation (DBS), remains dominant, capturing over 56% of the market revenue in 2025.
• tDCS Devices: The market for Transcranial Direct Current Stimulation (tDCS) devices, a low-cost, non-invasive alternative, is projected to reach $500 million by 2025, with an anticipated CAGR of approximately 15%.

This rising tide of non-invasive alternatives, particularly low-cost tDCS for home use, pressures BrainsWay to continuously prove the superior efficacy and depth of its proprietary Deep TMS technology.

Software updates and AI integration improve treatment planning and personalized patient outcomes.

The future of neuromodulation is in marrying powerful hardware with smart software to personalize therapy. The recent FDA clearance for the accelerated MDD protocol required a significant update to the stimulator software, demonstrating the importance of the digital layer in delivering new clinical benefits.

The next-generation Deep TMS 360™ system is a hardware-software innovation, featuring a multichannel architecture designed to provide more comprehensive and uniform stimulation to targeted brain regions. This is a critical step toward personalized medicine, allowing for more flexible and precise targeting, which is essential for complex conditions like chronic AUD where cortical atrophy (brain shrinkage) can complicate treatment.

Maintaining a strong patent portfolio is vital to protect the core Deep TMS intellectual property.

The company's proprietary technology is protected by a robust patent portfolio, including an exclusive license from the U.S. National Institutes of Health (NIH) for the core Deep TMS technology. This intellectual property (IP) is the foundation of their competitive advantage over traditional Transcranial Magnetic Stimulation (TMS) systems.

BrainsWay is actively defending and expanding its IP position, notably by developing the next-generation multi-channel TMS stimulator (Deep TMS 360™) based on an acquired multi-channel TMS patent portfolio and an exclusive option agreement with Stanford University. This strategic move ensures the company's technology remains protected as it advances into more complex, multi-target brain disorders.

Technological Metric	2025 Fiscal Year Data / Status	Strategic Implication
R&D Expense (9M 2025)	$7.072 million (Net)	Funding new indications and next-gen hardware development.
New MDD Protocol Clearance	Accelerated Deep TMS™ (Acute phase reduced to 6 days)	Improves patient compliance and clinic throughput; a major competitive differentiator.
New System/Coil	Deep TMS 360™ System (Multichannel architecture)	Enables more comprehensive and uniform stimulation for complex disorders like AUD.
NIH Research Grant	$2.5 million over five years (for AUD study)	Validates technology with non-dilutive funding for new indications.
tDCS Market Size (2025 Projection)	$500 million, growing at ~15% CAGR	Highlights intensifying competition from lower-cost, non-invasive alternatives.

BrainsWay Ltd. (BWAY) - PESTLE Analysis: Legal factors

You're looking at the legal and regulatory landscape for BrainsWay, and the key takeaway is that while US Food and Drug Administration (FDA) clearances are driving significant near-term revenue growth, the constant threat of patent litigation and the heavy compliance burden of the European Union's Medical Device Regulation (MDR) present real, quantifiable risks.

The company's ability to execute on its raised full-year 2025 revenue guidance of $51 million to $52 million hinges directly on navigating these legal and regulatory pathways efficiently.

The US Food and Drug Administration (FDA) clearance process for new indications dictates market timing.

The FDA clearance process is the primary engine for market expansion in the US, and BrainsWay has been very active in 2025. The Deep Transcranial Magnetic Stimulation (Deep TMS) system already holds three primary FDA clearances for Major Depressive Disorder (MDD), Obsessive-Compulsive Disorder (OCD), and smoking addiction.

Two new, pivotal FDA clearances in the second half of 2025 significantly expand the addressable market and accelerate treatment capacity. This is a game-changer for patient throughput.

• Accelerated Deep TMS Protocol for MDD: Cleared on September 16, 2025, this protocol reduces the acute treatment phase from four weeks of daily sessions to just six treatment days, which dramatically increases the capacity of the installed base of over 1,600 systems.
• Deep TMS for Adolescent MDD: Cleared on November 13, 2025, this expands the label to include adolescents aged 15 to 21 as an adjunct therapy.

Near-term market timing is still dictated by the pipeline. For instance, the company is actively pursuing the Post-Traumatic Stress Disorder (PTSD) indication, which is a significant clinical focus, and has launched its first clinical trial for Alcohol Use Disorder (AUD) in November 2025, supported by a $2.5 million grant from the National Institutes of Health (NIH). The delay in any of these clearances pushes out potential revenue by years.

Compliance with the Health Insurance Portability and Accountability Act (HIPAA) for patient data security is mandatory.

As a medical device company with an expanding network of clinical providers, BrainsWay is subject to the stringent requirements of the Health Insurance Portability and Accountability Act (HIPAA). This legislation governs the security and privacy of protected health information (PHI) in the US. The risk is significant because the Deep TMS system is integrated into clinical practice, and the company is making strategic minority investments in US mental health providers (four in 2025, including an initial $1.5 million investment in Heading Health).

Any data breach or non-compliance event could result in massive fines and reputational damage. While there were no reported HIPAA fines against BrainsWay in 2025, the company's SEC filings consistently cite the risk of regulatory non-compliance as a material factor.

Potential patent infringement litigation poses a financial and operational risk.

The Deep TMS technology is protected by a robust intellectual property (IP) portfolio, but this makes the company a target for litigation from competitors seeking to challenge its market position. This is a perpetual cost of doing business in the MedTech space.

We saw a direct financial impact in the second quarter of 2025, where the company reported a one-time $258 thousand charge for 'Restructuring and litigation Cost' as an adjustment to its Adjusted EBITDA calculation. This expense, though minor relative to the Q2 2025 revenue of $12.6 million, is a concrete example of the ongoing legal costs associated with defending its IP.

International regulatory hurdles, like the European Union's Medical Device Regulation (MDR), affect global sales.

The EU's Medical Device Regulation (MDR) represents a significant non-tariff barrier for all foreign medical device manufacturers, including BrainsWay. The regulation is far more complex and resource-intensive than the previous directives, creating a bottleneck for market access in Europe. This is a critical factor for global sales, which contribute to the company's total revenue.

Here's the quick math on the MDR challenge:

MDR Compliance Challenge	2025 Impact and Metrics	Risk to BrainsWay
Notified Body Bottleneck	As of mid-2025, 28,489 MDR applications filed, but only 12,177 certificates issued.	Delays in recertification of existing Deep TMS devices or new product launches, potentially stalling European revenue.
Certification Timeline	60% of MDR submissions take 13 to 18 months from application to final certificate.	Extended time-to-market for new Deep TMS coils or software updates, impacting competitive advantage.
New Compliance Deadlines	Mandatory direct UDI marking on Class IIa/IIb reusable devices by May 26, 2025.	Increased operational and manufacturing costs to meet new labeling and data submission requirements.

The entire regulatory ecosystem in the EU is still constrained by a shortage of Notified Bodies, which means even a fully compliant submission can face a long wait. Also, the new cybersecurity rules under the Radio Equipment Directive (RED) will apply from August 1, 2025, adding another layer of mandatory compliance for their internet-connected devices.

BrainsWay Ltd. (BWAY) - PESTLE Analysis: Environmental factors

Increasing pressure from institutional investors for transparent Environmental, Social, and Governance (ESG) reporting.

You are seeing a massive shift in how institutional capital is allocated, and BrainsWay Ltd. is not immune to the pressure for transparent ESG (Environmental, Social, and Governance) disclosure. While the company's core mission is inherently social-improving mental health-its environmental footprint remains largely opaque to the public and investors.

The broader medical device (MedTech) industry is under intense scrutiny, with activist investors targeting larger firms like Medtronic in 2025 over governance and sustainability issues. For a growth-focused company like BrainsWay, which is guiding for full-year 2025 revenue between $51 million - $52 million, the lack of a public ESG or Sustainability Report is a clear risk. Investors want to see quantifiable metrics, not just mission statements. The absence of a formal disclosure makes it defintely harder for ESG funds to justify a significant position.

Need to manage the end-of-life disposal and recycling of complex medical device hardware.

The Deep Transcranial Magnetic Stimulation (Deep TMS) system is a complex piece of capital equipment, not a disposable item, but its eventual end-of-life disposal presents a material environmental challenge. The global healthcare sector generates over 6,600 tons of waste daily from medical devices, and BrainsWay contributes to this with an installed base of more than 1,600 systems globally as of Q3 2025.

Each system contains specialized electronics, cooling components, and electromagnetic coils (H-Coils) that require careful management to prevent heavy metals and electronic waste (e-waste) from entering landfills. The company's business model, where approximately 70% of recent customer engagements are structured as multi-year lease agreements, actually offers a significant opportunity here. Leasing makes it easier to implement a closed-loop take-back and refurbishment program, ensuring devices are either recycled responsibly or refurbished for a second life, but a formal program has not been publicly detailed.

Here's the quick math on the disposal challenge:

Metric	Value (FY 2025 Data)	Environmental Implication
Total Installed Systems (Q3 2025)	>1,600 units	Represents the total e-waste liability.
Q3 2025 Systems Shipped	90 units	Adds to the long-term disposal pipeline.
Industry Daily Waste (Global)	>6,600 tons	Contextualizes the MedTech waste problem.

Energy consumption of manufacturing and clinical systems must align with sustainability goals.

The Deep TMS system's core function involves generating a powerful magnetic field, which requires substantial electrical power and a robust cooling system. While I don't have the exact kilowatt-hour (kWh) consumption for the commercial Deep TMS system, the company's own research highlights a commitment to efficiency in design.

Specifically, the multi-channel TMS stimulator design, which is integral to the Deep TMS platform, demonstrated a significant saving in energy consumption and a reduction in coil heating compared to older, standard single-channel TMS technology. This engineering advantage is a strong point to build a sustainability narrative around. Still, without public reporting, investors cannot verify the total energy footprint (Scope 1 and 2 emissions) of the manufacturing facilities or the aggregate energy use of the entire installed base.

• Quantify system energy use (e.g., kWh/treatment) for transparency.
• Procure renewable energy for manufacturing sites.
• Design for maximum energy efficiency in the next-generation cooling system.

Supply chain audits are required to ensure ethical sourcing of raw materials.

As a manufacturer of complex electronic and magnetic medical devices, BrainsWay is reliant on a global supply chain for raw materials, including copper for its proprietary H-Coils, various plastics, and electronic components that may contain conflict minerals. The industry trend in 2025 is toward mandatory supply chain due diligence, driven by regulations like the EU's Corporate Sustainability Due Diligence Directive (CSDDD).

While BrainsWay has a Code of Business Conduct and Ethics that broadly addresses integrity and ethical conduct with suppliers, there is no public evidence of a specific, formal supply chain audit program focused on environmental criteria. This lack of transparency creates a reputational and regulatory risk. The company must implement a rigorous audit process to verify that its suppliers adhere to environmental standards, specifically concerning the sourcing of materials that have a high environmental impact, such as those linked to deforestation or high-pollution manufacturing processes.