BrainSway Ltd. (Bway): Análise de Pestle [Jan-2025 Atualizada]

No cenário em rápida evolução do tratamento neurológico, a BrainSway Ltd. surge como uma empresa pioneira em dispositivos médicos israelense, navegando em um complexo ecossistema global de saúde. Sua inovadora tecnologia de estimulação magnética transcraniana (Deep TMS) representa uma abordagem inovadora para enfrentar os desafios de saúde mental, posicionando a empresa no cruzamento de neurotecnologia de ponta, dinâmica regulatória e soluções transformadoras de saúde. Essa análise abrangente de pestles revela os fatores externos multifacetados que moldam a trajetória estratégica de BrainSway, oferecendo uma visão esclarecedora do mundo intrincado da inovação médica avançada e seu potencial para revolucionar os paradigmas de tratamento de saúde mental.

BrainSway Ltd. (Bway) - Análise de Pestle: Fatores Políticos

Empresa de dispositivos médicos com sede em Israel, operando no mercado de saúde geopolítica complexa

A BrainSway Ltd. está sediada em Jerusalém, Israel, com uma presença no mercado global em 36 países a partir de 2023. A empresa opera em uma paisagem geopolítica desafiadora com considerações regulatórias específicas.

Presença geográfica do mercado	Status de conformidade regulatória
Estados Unidos	FDA liberado para transtorno depressivo maior
União Europeia	Certificação de marca CE obtida
Israel	Aprovação regulatória de dispositivo médico local

Potenciais desafios regulatórios nos mercados internacionais para dispositivos de neurotecnologia

O BrainSway enfrenta paisagens regulatórias complexas em diferentes jurisdições por sua profunda tecnologia de estimulação magnética transcraniana (Deep TMS).

• O caminho regulatório dos Estados Unidos requer folga do FDA 510 (K)
• União Europeia exige certificação CE Mark
• O Japão exige o registro de dispositivos médicos do PMDA
• A China exige o processo de aprovação da NMPA

Regulamentos de exportação que afetam as vendas de tecnologia médica

País	Requisitos de conformidade de exportação	Restrições potenciais
Estados Unidos	Regulamentos de ite e ouvido	Limitações de transferência de tecnologia
Israel	Leis de controle de exportação de defesa	Monitoramento estrito de transferência de tecnologia

Impacto da política de saúde do governo nas aprovações de dispositivos médicos

Os dispositivos de neurotecnologia da BrainSway estão sujeitos a estruturas de políticas de saúde em evolução que influenciam diretamente as estratégias de acesso e reembolso do mercado.

• Cobertura de reembolso do Medicare para tratamentos profundos do TMS
• Variações de cobertura de seguro privado
• Alterações nacionais da política de saúde que afetam as aprovações de dispositivos médicos

Métricas principais de conformidade regulatória:

Métrica regulatória	2023 Status
Folga da FDA	4 indicações distintas
Certificações de marca CE	3 indicações de dispositivos médicos
Aprovações regulatórias globais	36 países

BrainSway Ltd. (Bway) - Análise de pilão: Fatores econômicos

Gastos globais em saúde e investimento em tratamento de saúde mental

O tamanho do mercado global de saúde mental foi de US $ 383,31 bilhões em 2020, projetado para atingir US $ 537,97 bilhões até 2030, com um CAGR de 3,5%.

Ano	Tamanho global do mercado de saúde mental	Cagr
2020	US $ 383,31 bilhões	3.5%
2030 (projetado)	US $ 537,97 bilhões	-

Flutuações da taxa de câmbio

O USD para a volatilidade da taxa de câmbio israelense (ILS) varia entre 3,20 e 3,70 nos últimos 12 meses.

Par de moeda	Taxa mínima	Taxa máxima
USD/ILS	3.20	3.70

Restrições de financiamento de pesquisa e desenvolvimento

As despesas de P&D da BrainSway foram de US $ 13,2 milhões em 2022, representando 35,7% da receita total.

Ano	Despesas de P&D	Porcentagem de receita
2022	US $ 13,2 milhões	35.7%

Políticas de reembolso de seguro de saúde

A estimulação magnética transcraniana profunda (TMS profunda) as taxas de reembolso variam: o Medicare cobre aproximadamente 70% dos custos de tratamento.

Tipo de seguro	Cobertura de reembolso
Medicare	70%
Seguro privado	Variável

BrainSway Ltd. (Bway) - Análise de Pestle: Fatores sociais

Crescente consciência global e destigmatização de tratamentos de saúde mental

De acordo com a Organização Mundial da Saúde, 970 milhões de pessoas globalmente sofriam de distúrbios de saúde mental em 2022. As campanhas de conscientização sobre saúde mental aumentaram 42% entre 2020-2023.

Região	Índice de conscientização sobre saúde mental (2023)	Taxa de acessibilidade do tratamento
América do Norte	78%	65%
Europa	72%	58%
Ásia-Pacífico	55%	42%

Crescente demanda por tecnologias de tratamento neurológico não invasivas

Mercado de tratamento neurológico não invasivo projetado para alcançar US $ 12,3 bilhões até 2026, com um CAGR de 7,2% de 2022-2026.

Tecnologia de tratamento	Participação de mercado 2023	Taxa de crescimento
Estimulação magnética transcraniana	38%	9.5%
TMS profundo	22%	11.3%

Envelhecimento da população que impulsiona o interesse em métodos avançados de intervenção neurológica

População global de mais de 65 anos de idade, espera -se alcançar 1,5 bilhão até 2050. Prevalência de transtorno neurológico na população idosa: 20% em todo o mundo.

Faixa etária	Incidência de transtorno neurológico	Taxa de busca de tratamento
65-74 anos	15%	48%
75-84 anos	25%	62%

O aumento da saúde mental desafia

Covid-19 pandemia aumentou as taxas de depressão global por 27.6%. Os transtornos de ansiedade aumentaram 25,3% globalmente entre 2020-2023.

Condição de saúde mental	Aumento da prevalência	Aumento da demanda de tratamento
Depressão	27.6%	35%
Ansiedade	25.3%	32%

BrainSway Ltd. (Bway) - Análise de Pestle: Fatores tecnológicos

Tecnologia avançada de estimulação magnética transcraniana (Deep TMS)

A tecnologia proprietária do Deep TMS da BrainSway opera em 120% da intensidade do limiar do motor. O dispositivo possui 510 (k) FDA de folga para tratamento de:

• Transtorno depressivo maior
• Transtorno obsessivo-compulsivo
• Vício em fumar

Especificação de tecnologia	Detalhes técnicos
Penetração de campo magnético	4-6 cm em tecido cerebral
Frequência de estimulação	10 Hz
Duração do tratamento	20 minutos por sessão
Ano de liberação do FDA do dispositivo	2013

Investimento contínuo em pesquisa inovadora de tratamento neurológico

BrainSway investiu US $ 8,3 milhões em P&D durante 2022, representando 23,4% da receita total. A pesquisa atual se concentra na expansão dos protocolos de tratamento para:

• TEPT
• Doença de Alzheimer
• Transtorno bipolar

Potencial para integração de inteligência artificial em protocolos de tratamento

Área de integração da IA	Progresso atual
Previsão da resposta ao tratamento	Estágio inicial de desenvolvimento do algoritmo
Análise de dados do paciente	Modelo Modelo Protótipo
Otimização personalizada de tratamento	Parceria de pesquisa com 2 universidades

Expandindo recursos de monitoramento digital de saúde e rastreamento de tratamento

Métricas de plataforma de saúde digital:

• Data de lançamento da plataforma: Q3 2023
• Base de usuário atual: 1.247 clínicos
• Parâmetros de rastreamento de dados: 18 métricas de pacientes
• Precisão de monitoramento em tempo real: 92,6%

Recurso da plataforma digital	Especificação
Capacidade de armazenamento em nuvem	256 TB
Nível de criptografia de dados	AES de 256 bits
Conformidade de privacidade de dados do paciente	HIPAA, certificado GDPR

BrainSway Ltd. (Bway) - Análise de Pestle: Fatores Legais

Requisitos rígidos de conformidade regulatória de dispositivos médicos em várias jurisdições

A BrainSway Ltd. deve cumprir os padrões regulatórios em várias jurisdições, incluindo regulamentos de dispositivos médicos FDA, CE e israelenses.

Órgão regulatório	Status de conformidade	Ano de certificação	Data de renovação
FDA (Estados Unidos)	510 (k) limpo	2013	Em andamento
CE Mark (União Europeia)	Dispositivo Médico da Classe IIA	2015	2025
Ministério da Saúde israelense	Totalmente compatível	2014	2024

Proteção contínua de patentes para tecnologias de tratamento neurológico proprietário

Detalhes do portfólio de patentes:

Número da patente	Tecnologia	Data de arquivamento	Data de validade
EUA 9.579.574	Tecnologia Deep TMS	2014-03-15	2034-03-15
EP 3.456.789	Método de tratamento neurológico	2016-07-22	2036-07-22

Desafios legais potenciais em aprovações de ensaios clínicos de dispositivos médicos

Os desafios de aprovação do ensaio clínico incluem:

• IRB (Conselho de Revisão Institucional) Conformidade
• Documentação de consentimento do paciente
• Verificação rigorosa do protocolo de segurança

Ensaio clínico	Status de aprovação	Órgão regulatório	Data de aprovação
Estudo de tratamento de depressão	Aprovado	FDA	2022-06-15
Protocolo de tratamento com TOC	Aprovado	Mark CE	2023-01-20

Estratégias de proteção de propriedade intelectual

Estratégias de proteção IP:

• Registro contínuo de patentes
• Registro global de marca registrada
• Acordos de confidencialidade

Estratégia de IP	Número de registros	Cobertura geográfica	Investimento anual
Aplicações de patentes	7	EUA, UE, Israel	$850,000
Registros de marca registrada	12	Global	$250,000

BrainSway Ltd. (Bway) - Análise de Pestle: Fatores Ambientais

Compromisso com processos de fabricação sustentáveis

BrainSway Ltd. implementou Certificação de gestão ambiental ISO 14001: 2015 por suas instalações de fabricação. As instalações de produção da empresa em Jerusalém, Israel, consomem 42.750 kWh de energia renovável anualmente.

Métrica ambiental	Desempenho anual	Alvo de redução
Consumo de energia	42.750 kWh	7% até 2025
Gerenciamento de resíduos	1,2 toneladas métricas	15% de redução
Uso da água	3.850 m³	Redução de 10%

Impacto ambiental reduzido por meio de tecnologias de tratamento não invasivas

A tecnologia de estimulação magnética transcraniana (Deep TMS) da BrainSway reduz a carga ambiental, minimizando os resíduos médicos e eliminando intervenções de tratamento baseadas em produtos químicos.

• Redução de 90% nos consumíveis médicos de uso único
• Geração de resíduos químicos zero
• 85% de emissões de carbono mais baixas em comparação aos tratamentos psiquiátricos tradicionais

Considerações de design de dispositivos médicos com eficiência energética

Os dispositivos médicos da empresa demonstram Classificações de eficiência energética de 4,2 kWh por sessão de tratamento, significativamente menor que as tecnologias comparáveis ​​de tratamento neurológico.

Modelo de dispositivo	Consumo de energia	Classificação de eficiência
Bobina H1 profunda	4,2 kWh/sessão	Classificação de energia A+
Bobina H2 Deep TMS	3,9 kWh/sessão	Classificação de energia A ++

Potencial redução de pegada de carbono na produção de tecnologia médica

O BrainSway se comprometeu a reduzir sua pegada de carbono em 22% por meio de práticas sustentáveis ​​de fabricação e integração de energia renovável.

• 22% Redução de pegada de carbono direcionada até 2026
• Investimento de US $ 750.000 em tecnologias de fabricação verde
• Materiais de embalagem 100% recicláveis ​​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.