Sensus Healthcare, Inc. (SRTS): Análisis PESTLE [Actualizado en Ene-2025]

En el panorama de tecnología médica en rápida evolución, Sensus Healthcare, Inc. (SRTS) se encuentra en la intersección crítica de la innovación y la dinámica integral del mercado. Este análisis de machos de inmersión profunda presenta las fuerzas externas multifacéticas que configuran el posicionamiento estratégico de la Compañía, desde complejos desafíos regulatorios hasta avances tecnológicos innovadores en las soluciones de tratamiento de radiación. Al diseccionar factores políticos, económicos, sociológicos, tecnológicos, legales y ambientales, exponemos el complejo ecosistema que impulsa el potencial de crecimiento, resistencia e impacto transformador de Sensus Healthcare en el sector de la tecnología oncológica.

Sensus Healthcare, Inc. (SRTS) - Análisis de mortero: factores políticos

FDA Regulatory Landscape impacta procesos de aprobación de dispositivos médicos

A partir de 2024, el proceso de aprobación del dispositivo médico de la FDA implica:

Categoría de aprobación	Tiempo de revisión promedio	Tasa de éxito
Dispositivos de clase I	1-2 semanas	98.5%
Dispositivos de clase II	3-6 meses	87.3%
Dispositivos de clase III	12-18 meses	62.7%

Los cambios en la política de salud de EE. UU. Afectan los mercados de tecnología de radiación médica

Impacto actual de la política de salud en la tecnología de radiación médica:

• Tasa de reembolso de Medicare para radioterapia: $ 1,245 por sesión
• Cobertura de Medicaid para equipos de radiación: 67% de los costos totales
• Asignación anual de presupuesto federal para tecnología médica: $ 3.2 mil millones

Las políticas de reembolso del gobierno influyen en la adopción de equipos de tratamiento del cáncer

Categoría de reembolso	Porcentaje de cobertura	Presupuesto anual
Equipo de tratamiento del cáncer	75%	$ 1.7 mil millones
Procedimientos de radioterapia	82%	$ 1.3 mil millones

Cambios potenciales en las regulaciones de importación/exportación de dispositivos médicos

Marco regulatorio de importación/exportación actual:

• Tarifas de importación de dispositivos médicos: 2.7%
• Requisitos de cumplimiento de la exportación: 14 puntos de control regulatorios diferentes
• Valor comercial anual de dispositivos médicos: $ 42.3 mil millones

Sensus Healthcare, Inc. (SRTS) - Análisis de mortero: factores económicos

Crecimiento del mercado de dispositivos médicos en tecnologías de tratamiento del cáncer

El tamaño del mercado global de dispositivos médicos fue de $ 495.46 mil millones en 2022, proyectado para llegar a $ 795.74 mil millones para 2030, con una tasa compuesta anual del 6.1%. Se espera que el segmento de tecnología de tratamiento del cáncer crezca de $ 42.3 mil millones en 2022 a $ 68.7 mil millones para 2027.

Año	Tamaño del mercado ($ b)	Tocón
2022	42.3	6.5%
2027	68.7	6.5%

Gastos en salud y compras de equipos de capital

El gasto en salud de los Estados Unidos alcanzó los $ 4.5 billones en 2022, lo que representa el 17.3% del PIB. Los gastos de equipos médicos estimados en $ 392 mil millones en 2023.

Métrico	Valor 2022	2023 proyección
Gasto total de atención médica	$ 4.5 billones	$ 4.7 billones
Gasto de equipos médicos	$ 380 mil millones	$ 392 mil millones

Impacto en los tipos de cambio en las ventas internacionales

Impacto de la volatilidad monetaria en los ingresos internacionales de Sensus Healthcare:

• El tipo de cambio USD/EUR fluctuó entre 0.90-1.10 en 2023
• El tipo de cambio USD/JPY varió de 130-150 durante 2023

Pareja	2023 bajo	2023 alto
USD/EUR	0.90	1.10
USD/JPY	130	150

Impacto potencial de recesión económica

El FMI pronostica un crecimiento económico global en 3.0% en 2024, por debajo del 3.4% en 2022. La inversión en tecnología de salud se espera que se moderen, pero siguen siendo resistentes.

Indicador económico	2022	2024 proyección
Crecimiento económico global	3.4%	3.0%
Crecimiento de la inversión en tecnología de salud	5.7%	4.5%

Sensus Healthcare, Inc. (SRTS) - Análisis de mortero: factores sociales

El aumento de la conciencia del cáncer impulsa la demanda de soluciones avanzadas de tratamiento de radiación

Según la Sociedad Americana del Cáncer, se estima que se diagnosticaron 1,9 millones de casos de cáncer nuevos en los Estados Unidos en 2023. Las iniciativas mundiales de concientización sobre el cáncer han llevado a un aumento del 20.3% en las tasas de detección temprana en los últimos cinco años.

Métrica de conciencia del cáncer	2023 datos
Nuevos casos de cáncer (EE. UU.)	1,900,000
Aumento de la tasa de detección temprana	20.3%
Programas globales de detección del cáncer	387

La población que envejece crea un mercado ampliado para tecnologías de tratamiento del cáncer no invasivas

Las Naciones Unidas informan que la población global de 65 años o más alcanzará 1.500 millones para 2050, lo que representa un aumento del 16% de los niveles actuales. Se proyecta que la demanda de tratamiento del cáncer de población de edad avanzada crecerá en un 35% en la próxima década.

Estadística de envejecimiento de la población	Valor proyectado
Población global 65+ para 2050	1,500,000,000
Aumento de la demanda del tratamiento del cáncer	35%
Pacientes de cáncer de edad avanzada a nivel mundial	58,000,000

Creciente preferencia del paciente por radioterapia precisa y dirigida

La investigación indica que el 68% de los pacientes con cáncer prefieren opciones de tratamiento mínimamente invasivas. Se espera que el mercado de radioterapia dirigido alcance los $ 8.7 mil millones a nivel mundial para 2026.

Preferencia de radioterapia	Estadística
Preferencia del paciente por la terapia dirigida	68%
Mercado global de radiación dirigida (2026)	$8,700,000,000
Tasa de crecimiento anual	7.2%

El aumento del consumismo de la salud enfatiza las opciones de tratamiento médico personalizado

Se proyecta que el mercado de personalización de la salud alcanzará los $ 336.3 mil millones para 2025. Las decisiones de atención médica impulsadas por el paciente han aumentado en un 45% en los últimos tres años.

Métrica de consumo de atención médica	Valor
Mercado de atención médica personalizada (2025)	$336,300,000,000
Aumento de la decisión impulsada por el paciente	45%
Tasa de adopción de tratamiento personalizado	62%

Sensus Healthcare, Inc. (SRTS) - Análisis de mortero: factores tecnológicos

Innovación continua en equipos de tratamiento de radiación precisos

La plataforma SRT-100 Vision ™ de Sensus Healthcare representa una inversión de mercado de $ 2.3 millones en tecnología precisa de tratamiento de radiación. El dispositivo demuestra la precisión del tratamiento del 94.5% para los cánceres de piel no melanoma con un margen de precisión de 3-5 mm.

Tecnología	Precisión	Tasa de éxito del tratamiento
Srt-100 Vision ™	3-5 mm	94.5%

IA e integración de aprendizaje automático en planificación de radioterapia

Sensus Healthcare invirtió $ 1.7 millones en algoritmos de planificación del tratamiento impulsados ​​por la IA en 2023, reduciendo el tiempo de planificación del tratamiento en un 37% y mejorando la precisión de la dosis en un 22%.

Inversión de IA	Reducción del tiempo de planificación	Mejora de la precisión de la dosis
$ 1.7 millones	37%	22%

Tecnologías de imágenes avanzadas que mejoran la precisión del tratamiento

Las tecnologías de imágenes 3D de la compañía representan una inversión en I + D de $ 4.2 millones, lo que permite el seguimiento de tumores en tiempo real con una precisión de resolución espacial del 96.8%.

Tecnología de imágenes	Inversión de I + D	Resolución espacial
Seguimiento de tumores 3D	$ 4.2 millones	96.8%

Tendencias emergentes de miniaturización en dispositivos de radiación médica

Las plataformas de radioterapia compacta de Sensus Healthcare redujeron la huella del dispositivo en un 42%, y los costos de fabricación disminuyen en un 28% en 2023.

Característica del dispositivo	Porcentaje de reducción
Huella del dispositivo	42%
Costos de fabricación	28%

Sensus Healthcare, Inc. (SRTS) - Análisis de mortero: factores legales

Requisitos estrictos de cumplimiento de la FDA para fabricantes de dispositivos médicos

Sensus Healthcare, Inc. enfrenta rigurosa supervisión regulatoria de la FDA. A partir de 2024, la compañía debe cumplir con las siguientes métricas de cumplimiento:

Categoría de cumplimiento de la FDA	Requisitos específicos	Porcentaje de cumplimiento
Regulación del sistema de calidad (QSR)	21 CFR Parte 820	99.7%
Informes de dispositivos médicos (MDR)	Informes de eventos adversos	100%
Aprobación previa al mercado (PMA)	Envíos de dispositivos de clase III	3 presentaciones activas

Litigio potencial de patentes en el sector de la tecnología médica

Litigio de patentes Litigio para la atención médica sensus:

• Casos de patentes en curso: 2 procedimientos de litigio activo
• Gastos legales totales relacionados con disputas de patentes en 2023: $ 1.2 millones
• Portafolio de patentes: 17 patentes de tecnología médica activa

Impacto de las Regulaciones de Privacidad de la Atención Médica (HIPAA) en la gestión de datos

Métrica de cumplimiento de HIPAA	Estado 2024
Violaciones de privacidad de datos	0 incidentes reportados
Costo de auditoría de cumplimiento anual	$475,000
Inversión de protección de datos	$ 2.3 millones

Estándares de seguridad de dispositivos médicos y procesos de certificación

Métricas de certificación para dispositivos de salud sensus:

• ISO 13485: Certificación del sistema de gestión de calidad de dispositivos médicos 2016
• Certificaciones de CE Mark: 5 certificaciones de dispositivo activo
• Presupuesto anual de pruebas de seguridad: $ 1.7 millones
• Equipo de cumplimiento regulatorio: 12 profesionales a tiempo completo

Cumplimiento legal total y gastos regulatorios para 2024: $ 5.6 millones

Sensus Healthcare, Inc. (SRTS) - Análisis de mortero: factores ambientales

Creciente énfasis en la fabricación de equipos médicos sostenibles

Según el informe de sostenibilidad de equipos médicos globales de 2023, la industria de fabricación de dispositivos médicos tiene como objetivo reducir el impacto ambiental en un 35% para 2030. Las métricas de sostenibilidad actuales de Sensus Healthcare indican:

Métrica de sostenibilidad	Rendimiento actual	Objetivo de la industria
Uso de energía renovable	22.4%	40% para 2030
Materiales reciclados en producción	17.6%	30% para 2030
Reducción de emisiones de carbono	12.3%	50% para 2035

Consideraciones de eficiencia energética en tecnologías de tratamiento de radiación

Las tecnologías de tratamiento de radiación de Sensus Healthcare demuestran los siguientes parámetros de eficiencia energética:

• Consumo de energía por ciclo de tratamiento: 3.2 kWh
• Calificación de eficiencia energética: 4.5/5
• Ahorro anual de energía en comparación con modelos anteriores: 18.7%

Gestión de residuos electrónicos responsables en la producción de dispositivos médicos

Métrica de gestión de desechos electrónicos	2023 rendimiento
Residuos electrónicos reciclados	76.5 toneladas métricas
Socios certificados de eliminación de desechos electrónicos	7 socios
Reducción de material peligroso	42.3% de reducción desde 2020

Reducción de la huella de carbono en el desarrollo de tecnología médica

Métricas de reducción de huella de carbono para el desarrollo de tecnología médica de Sensus Healthcare:

• Emisiones totales de carbono en 2023: 1,245 toneladas métricas CO2E
• Inversiones de compensación de carbono: $ 375,000
• Año objetivo de neutralidad de carbono proyectado: 2035

Sensus Healthcare, Inc. (SRTS) - PESTLE Analysis: Social factors

You're looking at a market where the underlying demographic and patient preference trends are strongly in favor of Sensus Healthcare, Inc.'s core offering. The social environment is setting up a significant tailwind for non-invasive treatment adoption, provided the company can keep pace with demand and physician education.

Growing patient demand for non-invasive, non-surgical skin cancer treatment options like SRT

Patients are actively seeking alternatives to surgery for non-melanoma skin cancer (NMSC), which is a major driver for Superficial Radiation Therapy (SRT). This preference for non-invasive, scarless procedures is a clear market signal. Honestly, the numbers from early 2025 show this demand is translating directly into usage for Sensus Healthcare, Inc.'s systems.

For instance, in the first quarter of fiscal year 2025, the company noted a 65% quarter-over-quarter increase in the number of patient treatments delivered using their FDA-based SRT systems. This signals that once the technology is available, patients are choosing it. The overall Superficial Radiation Therapy System Market is projected to hit USD 48.4 billion in 2025, with the SRT systems segment dominating at 61.4% of that value.

Aging US population (Baby Boomers) increasing the incidence of non-melanoma skin cancer

The demographic shift toward an older population is perhaps the single biggest driver for NMSC cases. Skin cancer affects about 1 in 5 Americans over their lifetime, and the burden falls heavily on seniors. In 2021 alone, adults aged 65 and older accounted for approximately 2.8 million Basal Cell Carcinoma (BCC) cases and 1.5 million Squamous Cell Carcinoma (SCC) cases. This trend is not slowing down; projections suggest BCC incidence could more than double by 2050. SRT is particularly well-suited for this demographic, as it is noted to be especially safe and effective among the elderly who often have comorbidities that make surgery difficult.

Here's the quick math on the scale of the problem:

Metric	Value (Approximate/Projection)	Source Year/Context
Annual US BCC/SCC Diagnoses	5.4 million	Annual US estimate
US Population Lifetime Risk	1 in 5 Americans	Lifetime risk
BCC Incidence Projection (by 2050)	Could more than double	Projection
Mean Age of SRT Study Patients	79 years (SD 8.7)	Retrospective study data

What this estimate hides is that while BCC/SCC are common, the focus on early detection is critical, as late-stage disease carries higher risks.

Public health campaigns promoting early detection and treatment of basal and squamous cell carcinoma

The sheer volume of skin cancer cases-NMSC being the most common cancer in the US-keeps early detection and treatment in the public health spotlight. Organizations like the CDC actively promote sun safety and awareness, which drives patients to seek screening and, subsequently, treatment when lesions are found. Skin Cancer Awareness Month in May is a key annual event used to spread facts about sun protection and the importance of checking skin for warning signs.

When these common cancers are caught early, the survival rate is higher than 95%. This high success rate for early intervention reinforces the value proposition for non-invasive treatments like SRT, as patients are motivated to treat small, detected lesions promptly rather than waiting for surgical consultation.

Physician adoption rates of new technology based on perceived patient satisfaction and clinical outcomes

Physician adoption hinges on two things: good patient outcomes and, crucially, sound economics. For Sensus Healthcare, Inc., the recent regulatory clarity is a game-changer for adoption confidence. The Centers for Medicare & Medicaid Services (CMS) validated SRT as a standalone treatment modality by establishing distinct Current Procedural Terminology (CPT®) codes.

This isn't just administrative; it directly impacts the bottom line. The new codes mean an increase in reimbursement per fraction of more than 300% compared to previous codes, which significantly enhances physician economics. This certainty, coupled with the known clinical benefit-an estimated 98.9% of NMSCs not recurring after 85 months in one study-makes the case for adoption compelling. You can expect this financial clarity to accelerate the integration of SRT into dermatology and radiation oncology practices defintely.

• SRT offers non-surgical, outpatient treatment.
• Clinical efficacy shows low recurrence rates.
• Reimbursement certainty is now much stronger.
• Adoption is expected to accelerate post-2025.

Finance: draft 13-week cash view by Friday

Sensus Healthcare, Inc. (SRTS) - PESTLE Analysis: Technological factors

You're looking at the tech roadmap for Sensus Healthcare, and honestly, it's where the rubber meets the road for this company. The core value proposition is built on their Superficial Radiation Therapy (SRT) systems, but in 2025, that means constant evolution, not just resting on past clearances.

Continuous need for software updates and AI integration to enhance treatment planning and delivery

The technology isn't static; it requires continuous investment to stay ahead. Sensus Healthcare's flagship, the SRT-100 Vision, already incorporates Image-Guided SRT (IG-SRT) with an embedded high-frequency ultrasound module, volumetric tumor analysis, and beam margins planning. This integration of imaging directly into the treatment planning is a major technological leap. Furthermore, at the 2025 American Academy of Dermatology Annual Meeting, Sensus showcased an 'A.I.-focused environment,' signaling their commitment to leveraging artificial intelligence in workflows. If onboarding takes 14+ days, churn risk rises, so intuitive software that minimizes training time is key to adoption.

Here's the quick math on their Q3 2025 performance: Revenues were $6.9 million, which means R&D spending on these updates has to be highly efficient to drive future unit sales and recurring revenue from their Fair Deal Agreements.

Competitive pressure from other non-surgical modalities like cryotherapy and photodynamic therapy

SRT is fighting for share against other non-invasive options, and the market sizes show you the scale of the competition. You need to know what you're up against. The global Cryotherapy Market is projected to hit USD 6,059 Million in 2025, growing at a strong CAGR of 10.6% through 2035. Meanwhile, the Photodynamic Therapy (PDT) Market is expected to reach $4.88 billion in 2025. To be fair, the overall Skin Cancer Therapeutics Market is estimated at $15 billion in 2025, so there is plenty of room, but Sensus Healthcare needs to clearly articulate why SRT is superior to these established, non-surgical alternatives for specific indications like non-melanoma skin cancer and keloids.

You have to prove your precision beats the cold or the light.

Development of smaller, more portable, and lower-cost SRT systems (e.g., the SRT-100 Vision)

The trend in medical devices is always toward better accessibility and lower capital expenditure for the clinic. The SRT-100 Vision itself is an advancement, offering integrated imaging and planning. Beyond the core systems, Sensus Healthcare is actively developing pre-commercial products that point toward portability and enhanced detection. Specifically, they showcased a prototype handheld ultrasound device in early 2025, designed to help clinicians identify lesions and improve practice efficiency in a portable setting. Also, they are working on their TransDermal Infusion (TDI) product with Sentinel™ IT Solutions capabilities. These developments suggest a strategy to lower the barrier to entry and expand use cases beyond the traditional office setup.

The goal is to make the technology fit the workflow, not the other way around.

Protecting intellectual property (IP) against rapid imitation in the medical device space is defintely crucial

In the fast-moving medical device sector, protecting your unique technology is non-negotiable, especially when you have integrated features like the ultrasound guidance in the SRT-100 Vision. Rapid imitation can quickly erode any competitive advantage gained from innovation. While I don't see specific Sensus Healthcare IP litigation in the headlines for 2025, the broader landscape shows high-stakes patent disputes in tech. For Sensus Healthcare, this means maintaining a strong patent portfolio around the IG-SRT process, the ultrasound integration, and any future AI algorithms. A strong IP defense is your moat against competitors who might try to replicate the combination of imaging and therapy delivery.

Finance: draft 13-week cash view by Friday

Sensus Healthcare, Inc. (SRTS) - PESTLE Analysis: Legal factors

You're managing a medical device company like Sensus Healthcare, Inc., and the legal landscape is less about what happened last year and more about what the regulators and courts are signaling for the next quarter. The regulatory burden is heavy, but it's also the barrier to entry that protects your existing FDA-cleared technology, like the SRT-100 Vision.

Strict US Food and Drug Administration (FDA) clearance and post-market surveillance requirements for all devices

The FDA is your gatekeeper, and while you've successfully navigated clearances-evidenced by the ongoing use of your SRT-100 Vision system-the process is never truly over. You have to maintain compliance through rigorous post-market surveillance. For example, in March 2025, Sensus Healthcare announced the publication of a study on SRT-100 for keloids, which shows you are actively engaging with the clinical data required to support your indications. Furthermore, the recent validation of SRT for non-melanoma skin cancer via CMS CPT® codes in Q3 2025 is a huge win, but it also means the FDA and CMS will be watching utilization and outcomes closely.

Here's a snapshot of the current regulatory environment for devices like yours:

• FDA clearance is a prerequisite for market entry.
• Post-market surveillance is continuous data collection.
• New CMS coding validates technology but increases scrutiny.
• You exited Q3 2025 with $24.5 million in cash to fund compliance efforts.

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

HIPAA compliance isn't just about avoiding fines; it's about maintaining the trust that allows you to operate. The regulatory environment in 2025 is definitely tightening up. The Department of Health and Human Services (HHS) announced they will increase audit frequency and take a more punitive approach to violations. This means your internal controls need to be flawless, especially as your installed base grows-you had 21 FDA sites active by the end of Q3 2025.

The potential cost of a failure is steep, with fines ranging from $10,000 to $1.5 million per violation, and a proposed rule change that could slash the breach notification window from 60 days down to just 24 hours. You need to know exactly where all Protected Health Information (PHI) from your systems resides and how it's secured.

Ongoing risk of product liability lawsuits related to device performance or patient outcomes

This is the big one for any device manufacturer. Even with FDA clearance, you face the risk of product liability claims if a patient outcome is poor or if the device performance is alleged to be defective. Nationally, product liability cases are a major focus, accounting for two-thirds of all nuclear verdicts between 2013 and 2022, with median verdicts reaching $21 million in that period. While I don't see specific litigation against Sensus Healthcare, Inc. in the recent filings, the general trend means your legal reserves need to be robust enough to handle potential defense costs, even if you win. Your Q3 2025 net loss was $0.9 million, and managing unexpected legal costs against that margin is key.

We can map the general risk exposure:

Legal Risk Area	Industry Trend/Metric (as of 2025)	Implication for Sensus Healthcare, Inc.
Product Liability Verdicts	Median nuclear verdict in product liability cases: $21 million	Requires strong insurance coverage and robust clinical data defense.
HIPAA Fines	Potential fines up to $1.5 million per violation	Mandates immediate remediation for any identified PHI security gaps.
FDA Scrutiny	Increased focus following new CMS CPT® codes for SRT	Demands meticulous record-keeping for all device utilization data.

Evolving state-level regulations on the scope of practice for non-physician providers using SRT devices

It's not just Washington D.C. that matters; state boards dictate who can operate your equipment. As telehealth flexibilities granted during the public health emergency are set to expire for most services after September 30, 2025, the rules on where and by whom services can be rendered are reverting to older statutory limitations. This means that if your adoption strategy relies on non-physician providers operating devices remotely or under relaxed supervision, you need to check the specific scope of practice laws in every state where you have an installed base. A change in a single state's medical board ruling could suddenly restrict the utilization of your SRT systems by physician assistants or nurse practitioners.

Here are a few compliance checks you should run now:

• Confirm current state-specific rules for non-physician use.
• Review telehealth reimbursement rules expiring post-September 2025.
• Ensure all documentation aligns with the new, stricter HIPAA breach timeline.

Finance: draft 13-week cash view by Friday.

Sensus Healthcare, Inc. (SRTS) - PESTLE Analysis: Environmental factors

You're a medical device manufacturer with a growing installed base of SRT systems, meaning the end-of-life management of that hardware is becoming a real liability, not just a footnote in the annual report. Honestly, the market is watching your ESG moves closely, especially given the regulatory headwinds coming down the pipe.

Managing the safe disposal of electronic waste (e-waste) from older or decommissioned SRT systems

The hardware you sell-your SRT systems-eventually become e-waste, and that's a major environmental touchpoint. The US E-Waste Management Market size is projected to hit $16.0 billion in 2025, showing you're dealing with a massive, growing sector where responsible handling is key to reputation. Proper collection and recycling of e-waste can prevent significant $\text{CO}_2$ emissions, a metric investors are increasingly using to judge climate performance. For Sensus Healthcare, this means you need a clear, auditable take-back program for your decommissioned units, ensuring hazardous materials are kept out of landfills.

Here are the immediate actions to nail down:

• Finalize contracts with certified e-waste recyclers.
• Establish a clear, documented chain of custody for all retired SRT units.
• Calculate the estimated volume of e-waste generated from the 19 SRT systems shipped in Q2 2025 alone, factoring in system lifespan.

Increasing investor and public pressure for a verifiable environmental, social, and governance (ESG) framework

You've stated a commitment to sustainable practices, which is a start, but investors now demand more than just good intentions; they want verifiable numbers. The market is moving toward mandatory sustainability disclosures, meaning vague commitments won't cut it for long. You need to show how your operations-from sourcing to disposal-align with recognized standards.

What this estimate hides is the cost of not having a framework; poor ESG scores can lead to higher capital costs. To be fair, you must translate that general commitment into hard metrics. You need to define your baseline for Scope 1, 2, and 3 emissions now, even if you don't have a net-zero target yet. This is about building credibility.

Optimizing logistics and shipping to reduce the carbon footprint of system delivery and service calls

Every time an SRT system ships or a technician drives out for service, that's a Scope 3 emission you own. While your Q2 2025 revenue was $7.3 million, the associated logistics cost and carbon output need scrutiny. Think about the distance your service fleet covers. If you can shift even 10% of your service routes to optimized, lower-emission paths, that translates directly to lower operating costs and better ESG reporting.

Here's the quick math: If your average service call involves 150 miles of driving, reducing that by 15 miles per call across, say, 500 annual service calls saves 7,500 miles-that's real fuel savings you can quantify.

Compliance with international restrictions on hazardous substances in electronic equipment (e.g., RoHS)

Your international expansion, including shipments to China in Q2 2025, means you are directly exposed to global chemical restrictions like the EU's Restriction of Hazardous Substances (RoHS) directive. For medical devices (Category 8), compliance is mandatory to access key markets, and several exemptions under RoHS are set to expire in 2025, meaning substances previously allowed might now be restricted. This isn't just about the final product; it's about every component, from the connector to the plastic housing.

You must verify compliance across your supply chain:

• Obtain Certificates of Compliance (CoC) for all new electronic components.
• Ensure your supplier vetting process explicitly checks for RoHS 3 phthalate restrictions.
• Confirm that no active implantable device exemptions apply to your SRT systems, as they are the main exception.

Finance: draft 13-week cash view by Friday.