Brainsway Ltd. (Bway): Analyse du Pestle [Jan-2025 MISE À JOUR]

Dans le paysage rapide du traitement neurologique en évolution, Brainsway Ltd. émerge comme une société pionnière de dispositifs médicaux israéliens naviguant dans un écosystème de soins de santé complexe. Leur technologie innovante de stimulation magnétique transcrânienne profonde (TMS profonde) représente une approche révolutionnaire pour relever les défis de la santé mentale, positionner l'entreprise à l'intersection de la neurotechnologie de pointe, la dynamique réglementaire et les solutions de soins de santé transformateurs. Cette analyse complète du pilon dévoile les facteurs externes à multiples facettes qui façonnent la trajectoire stratégique de Brainsway, offrant un aperçu éclairant dans le monde complexe de l'innovation médicale avancée et son potentiel pour révolutionner les paradigmes de traitement de la santé mentale.

Brainsway Ltd. (Bway) - Analyse du pilon: facteurs politiques

Société de dispositifs médicaux basée à Israël opérant sur le marché des soins de santé géopolitique complexes

Brainsway Ltd. a son siège social à Jérusalem, en Israël, avec une présence mondiale sur le marché dans 36 pays en 2023. La société opère dans un paysage géopolitique difficile avec des considérations réglementaires spécifiques.

Présence du marché géographique	Statut de conformité réglementaire
États-Unis	La FDA est autorisée pour un trouble dépressif majeur
Union européenne	Certification CE Mark obtenue
Israël	Approbation réglementaire des dispositifs médicaux locaux

Défis réglementaires potentiels sur les marchés internationaux pour les dispositifs de neurotechnologie

Brainsway fait face à des paysages régulateurs complexes à travers différentes juridictions pour sa technologie de stimulation magnétique transcrânienne profonde (TMS profonde).

• La voie réglementaire des États-Unis nécessite une autorisation de la FDA 510 (k)
• Certification de l'Union européenne Demandes CE Mark
• Le Japon a besoin d'enregistrement des dispositifs médicaux PMDA
• La Chine oblige le processus d'approbation de la NMPA

Règlements d'exportation affectant les ventes de technologies médicales

Pays	Exportation des exigences de conformité	Restrictions potentielles
États-Unis	Règlement ITAR et oreille	Limitations de transfert de technologie
Israël	Lois de contrôle des exportations de défense	Surveillance stricte du transfert de technologie

Impact de la politique gouvernementale des soins de santé sur les approbations des dispositifs médicaux

Les dispositifs de neurotechnologie de Brainsway sont soumis à l'évolution des cadres de politique de santé qui influencent directement les stratégies d'accès au marché et de remboursement.

• Couverture de remboursement de l'assurance-maladie pour les traitements du TMS profond
• Variations de couverture d'assurance privée
• Modifications nationales de politique de santé affectant les approbations des dispositifs médicaux

Mesures de conformité réglementaire clés:

Métrique réglementaire	Statut 2023
Délies de la FDA	4 indications distinctes
Certifications CE Mark	3 indications des dispositifs médicaux
Approbations réglementaires mondiales	36 pays

Brainsway Ltd. (Bway) - Analyse du pilon: facteurs économiques

Investissement mondial des dépenses de santé et en santé mentale

La taille du marché mondial de la santé mentale était de 383,31 milliards de dollars en 2020, prévoyant à atteindre 537,97 milliards de dollars d'ici 2030, avec un TCAC de 3,5%.

Année	Taille du marché mondial de la santé mentale	TCAC
2020	383,31 milliards de dollars	3.5%
2030 (projeté)	537,97 milliards de dollars	-

Fluctuations de taux de change

La volatilité du taux de change USD à Israélien Shekel (ILS) varie entre 3,20 et 3,70 au cours des 12 derniers mois.

Paire de devises	Taux minimum	Taux maximal
USD / ILS	3.20	3.70

Contraintes de financement de la recherche et du développement

Les dépenses de R&D de Brainsway étaient de 13,2 millions de dollars en 2022, ce qui représente 35,7% des revenus totaux.

Année	Dépenses de R&D	Pourcentage de revenus
2022	13,2 millions de dollars	35.7%

Polices de remboursement de l'assurance santé

Les taux de remboursement de la stimulation magnétique transcrânienne profonde (TMS profonde) varient: Medicare couvre environ 70% des coûts de traitement.

Type d'assurance	Couverture de remboursement
Médicament	70%
Assurance privée	Variable

Brainsway Ltd. (Bway) - Analyse du pilon: facteurs sociaux

Conscience globale croissante et désactivation des traitements de santé mentale

Selon l'Organisation mondiale de la santé, 970 millions de personnes ont souffert de troubles de la santé mentale en 2022. Les campagnes de sensibilisation à la santé mentale ont augmenté de 42% entre 2020-2023.

Région	Indice de sensibilisation à la santé mentale (2023)	Taux d'accessibilité au traitement
Amérique du Nord	78%	65%
Europe	72%	58%
Asie-Pacifique	55%	42%

Demande croissante de technologies de traitement neurologique non invasives

Marché du traitement neurologique non invasif prévu pour atteindre 12,3 milliards de dollars d'ici 2026, avec un TCAC de 7,2% de 2022-2026.

Technologie de traitement	Part de marché 2023	Taux de croissance
Stimulation magnétique transcrânienne	38%	9.5%
TMS profond	22%	11.3%

Le vieillissement de la population stimulant l'intérêt des méthodes d'intervention neurologique avancées

Population mondiale âgée de 65 ans et plus 1,5 milliard d'ici 2050. Prévalence des troubles neurologiques dans la population âgée: 20% dans le monde.

Groupe d'âge	Incidence des troubles neurologiques	Taux de recherche de traitement
65-74 ans	15%	48%
75-84 ans	25%	62%

Les défis de santé mentale croissants après la pandémie après 19 ans créent des opportunités de marché

La pandémie Covid-19 a augmenté les taux de dépression mondiale 27.6%. Les troubles anxieux ont augmenté de 25,3% dans le monde entre 2020-2023.

Condition de santé mentale	Augmentation de la prévalence	Augmentation de la demande du traitement
Dépression	27.6%	35%
Anxiété	25.3%	32%

Brainsway Ltd. (Bway) - Analyse du pilon: facteurs technologiques

Technologie avancée de stimulation magnétique transcrânienne profonde (TMS profonde)

La technologie Deep TMS propriétaire de Brainsway fonctionne à 120% de l'intensité du seuil de moteur. L'appareil a 510 (k) Claitement de la FDA pour le traitement de:

• Trouble dépressif majeur
• Trouble obsessionnel compulsif
• Toxicomanie

Spécifications technologiques	Détails techniques
Pénétration du champ magnétique	4-6 cm dans les tissus cérébraux
Fréquence de stimulation	10 Hz
Durée du traitement	20 minutes par session
Année de dédouanement de la FDA de l'appareil	2013

Investissement continu dans la recherche innovante au traitement neurologique

Brainsway a investi 8,3 millions de dollars en R&D en 2022, représentant 23,4% des revenus totaux. Les recherches actuelles se concentrent sur l'expansion des protocoles de traitement pour:

• SSPT
• Maladie d'Alzheimer
• Trouble bipolaire

Potentiel d'intégration de l'intelligence artificielle dans les protocoles de traitement

Zone d'intégration d'IA	Progrès actuel
Prédiction de réponse au traitement	Étape initiale de développement de l'algorithme
Analyse des données des patients	Prototype de modèle d'apprentissage automatique
Optimisation du traitement personnalisé	Partenariat de recherche avec 2 universités

Expansion des capacités de surveillance de la santé numérique et de suivi du traitement

Métriques de la plate-forme de santé numérique:

• Date de lancement de la plate-forme: Q3 2023
• Base d'utilisateurs actuelle: 1 247 cliniciens
• Paramètres de suivi des données: 18 métriques des patients
• Précision de surveillance en temps réel: 92,6%

Fonctionnalité de plate-forme numérique	Spécification
Capacité de stockage cloud	256 TB
Niveau de chiffrement des données	AES 256 bits
Compliance de la confidentialité des données des patients	HIPAA, certifié du RGPD

Brainsway Ltd. (Bway) - Analyse du pilon: facteurs juridiques

Exigences strictes de conformité réglementaire des dispositifs médicaux dans plusieurs juridictions

Brainsway Ltd. doit se conformer aux normes réglementaires dans plusieurs juridictions, notamment la FDA, CE Mark et les réglementations des dispositifs médicaux israéliens.

Corps réglementaire	Statut de conformité	Année de certification	Date de renouvellement
FDA (États-Unis)	510 (k) effacé	2013	En cours
CE Mark (Union européenne)	Dispositif médical de classe IIA	2015	2025
Ministère israélien de la santé	Pleinement conforme	2014	2024

Protection des brevets en cours pour les technologies de traitement neurologique propriétaire

Détails du portefeuille de brevets:

Numéro de brevet	Technologie	Date de dépôt	Date d'expiration
US 9 579 574	Technologie profonde TMS	2014-03-15	2034-03-15
EP 3 456 789	Méthode de traitement neurologique	2016-07-22	2036-07-22

Défices juridiques potentiels dans les approbations des essais cliniques de dispositifs médicaux

Les défis d'approbation des essais cliniques comprennent:

• IRB (Institutional Review Board) Compliance
• Documentation du consentement du patient
• Vérification rigoureuse du protocole de sécurité

Essai clinique	Statut d'approbation	Corps réglementaire	Date d'approbation
Étude de traitement de la dépression	Approuvé	FDA	2022-06-15
Protocole de traitement du TOC	Approuvé	Marque CE	2023-01-20

Stratégies de protection de la propriété intellectuelle

Stratégies de protection IP:

• Dépôt de brevets continu
• Enregistrement de la marque mondiale
• Accords de confidentialité

Stratégie IP	Nombre de dépôts	Couverture géographique	Investissement annuel
Demandes de brevet	7	États-Unis, UE, Israël	$850,000
Inscriptions de la marque	12	Mondial	$250,000

Brainsway Ltd. (Bway) - Analyse du pilon: facteurs environnementaux

Engagement envers les processus de fabrication durables

Brainsway Ltd. a mis en œuvre ISO 14001: Certification de gestion de l'environnement 2015 pour ses installations de fabrication. Les installations de production de la société à Jérusalem, Israël consomment 42 750 kWh d'énergie renouvelable par an.

Métrique environnementale	Performance annuelle	Cible de réduction
Consommation d'énergie	42 750 kWh	7% d'ici 2025
Gestion des déchets	1,2 tonnes métriques	Réduction de 15%
Utilisation de l'eau	3 850 m³	Réduction de 10%

Réduction de l'impact environnemental grâce à des technologies de traitement non invasives

La technologie de stimulation magnétique transcrânienne profonde de Brainsway (TMS) réduit la charge environnementale en minimisant les déchets médicaux et en éliminant les interventions de traitement à base de produits chimiques.

• Réduction à 90% des consommables médicaux à usage unique
• Zéro production de déchets chimiques
• 85% d'émissions de carbone inférieures par rapport aux traitements psychiatriques traditionnels

Considérations de conception de dispositifs médicaux économes en énergie

Les dispositifs médicaux de l'entreprise démontrent notes d'efficacité énergétique de 4,2 kWh par séance de traitement, significativement inférieure aux technologies de traitement neurologique comparables.

Modèle d'appareil	Consommation d'énergie	Cote d'efficacité
Bobine profonde H1 TMS H1	4,2 kWh / session	A + Énergie
Bobine de TMS H2 profonde	3,9 kWh / session	A ++ Energy Rating

Réduction potentielle de l'empreinte carbone de la production de technologies médicales

Brainsway s'est engagé à réduire son empreinte carbone de 22% grâce à des pratiques de fabrication durables et à l'intégration des énergies renouvelables.

• 22% réduction de l'empreinte carbone ciblée d'ici 2026
• Investissement de 750 000 $ dans les technologies de fabrication verte
• Matériel d'emballage 100% recyclable mis en œuvre

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.