Nyxoah S.A. (NYXH): Análise de Pestle [Jan-2025 Atualizada]

No cenário em rápida evolução da tecnologia médica, a Nyxoah S.A. fica na vanguarda do tratamento inovador da apneia do sono, navegando em um complexo ecossistema global de desafios e oportunidades. Esta análise abrangente de pestles revela os fatores externos multifacetados que moldam a trajetória estratégica da empresa, de obstáculos regulatórios na Europa a avanços tecnológicos na neuroestimulação. Mergulhe em uma exploração intrincada de como a dinâmica política, econômica, sociológica, tecnológica, legal e ambiental converge para influenciar esse caminho inovador do caminho da Medtech Enterprise para transformar o atendimento ao paciente e o potencial de mercado.

Nyxoah S.A. (NYXH) - Análise de pilão: Fatores políticos

Empresa de tecnologia médica baseada na Bélgica em ambientes regulatórios complexos

A Nyxoah S.A. opera dentro de intrincadas paisagens políticas e regulatórias nos mercados europeus de saúde. A Companhia deve navegar por vários estruturas regulatórias para manter a conformidade e o acesso ao mercado.

Autoridade regulatória	Status de conformidade regulatória	Data de certificação
Agência Europeia de Medicamentos (EMA)	CE Mark aprovado	Setembro de 2021
Administração de Alimentos e Medicamentos dos EUA (FDA)	Designação de dispositivos inovadores	Novembro de 2020

Regulamentos de dispositivos médicos da União Europeia

Regulação de dispositivos médicos (MDR) 2017/745 impacta significativamente as estratégias de desenvolvimento de produtos e mercado da Nyxoah.

• Requisitos rigorosos de evidência clínica
• Mandados de vigilância pós-mercado aprimorados
• Protocolos abrangentes de gerenciamento de riscos

Tensões geopolíticas no comércio de tecnologia médica

Região	Índice de complexidade comercial	Barreiras regulatórias
União Europeia	Baixo (2,3/10)	Mínimo
Estados Unidos	Médio (5.7/10)	Moderado

Alterações da política de saúde nos mercados -alvo

A Nyxoah monitora continuamente os desenvolvimentos de políticas de saúde em todos os mercados importantes para adaptar as estratégias de expansão do mercado.

• Políticas de reembolso da Bélgica para dispositivos médicos
• Mecanismos de financiamento de inovação em saúde europeia
• Regulamentos internacionais de investimento em tecnologia médica

Mercado	Impacto da política de saúde	Complexidade potencial de entrada de mercado
Bélgica	Apoio	Baixo
Alemanha	Moderadamente restritivo	Médio
Estados Unidos	Ambiente regulatório complexo	Alto

Nyxoah S.A. (NYXH) - Análise de pilão: Fatores econômicos

Tecnologias de tratamento de crescimento e apneia do sono Medtech

O mercado global de dispositivos de apneia do sono foi avaliado em US $ 6,2 bilhões em 2022 e deve atingir US $ 9,8 bilhões até 2030, com um CAGR de 6,2%.

Desempenho financeiro e gastos com saúde

A Nyxoah S.A. relatou receita total de 5,1 milhões de euros no ano fiscal de 2022, com despesas de P&D de 16,4 milhões de euros.

Métrica financeira	2022 Valor	2021 Valor
Receita total	€ 5,1 milhões	2,8 milhões de euros
Despesas de P&D	€ 16,4 milhões	€ 12,6 milhões
Perda líquida	€ 20,1 milhões	€ 15,3 milhões

Flutuações econômicas globais e financiamento de P&D

A Medical Technology Venture Capital Investments totalizou US $ 16,3 bilhões em 2022, representando uma queda de 36% em relação a US $ 25,4 bilhões de 2021.

Riscos de câmbio

Par de moeda	Volatilidade da taxa de câmbio (2022)	Impacto na receita
EUR/USD	6,5% de flutuação	± € 0,3 milhão
EUR/GBP	4,2% de flutuação	± € 0,2 milhão

O reembolso do seguro de saúde para tratamentos de apneia do sono aumentou 4,3% em 2022, atingindo cerca de US $ 2,1 bilhões em todo o mundo.

Nyxoah S.A. (NYXH) - Análise de pilão: Fatores sociais

Aumentando a conscientização global sobre os distúrbios do sono que impulsionam a demanda do mercado

De acordo com a World Sleep Society, aproximadamente 45% Dos distúrbios globais da população experimenta do sono. O mercado global de distúrbios do sono foi avaliado em US $ 456,9 bilhões em 2022 e é projetado para alcançar US $ 647,7 bilhões até 2030.

Tipo de transtorno do sono	Prevalência global	Impacto no mercado
Apneia obstrutiva do sono	22% da população	Segmento de mercado de US $ 214,3 bilhões
Insônia	10-30% dos adultos	Segmento de mercado de US $ 132,6 bilhões

Envelhecimento da população e as taxas de obesidade crescentes expandem a base potencial de pacientes

População global de mais de 65 anos de idade, espera -se alcançar 1,5 bilhão até 2050. As taxas de obesidade em todo o mundo aumentaram para 13% em 2022, correlacionando -se diretamente com a prevalência do distúrbio do sono.

Faixa etária	Risco de transtorno do sono	Potencial população de pacientes
65-74 anos	40% maior risco	382 milhões de pacientes em potencial
75 anos ou mais	55% maior risco	276 milhões de pacientes em potencial

Crescente consumismo de saúde enfatizando soluções de tratamento não invasivas

O mercado de dispositivos médicos não invasivos que se espera alcançar US $ 274,6 bilhões até 2027, com 67% de pacientes preferindo tratamentos minimamente invasivos.

Mudança de preferências do paciente para tecnologias médicas minimamente invasivas

Mercado de tecnologia médica minimamente invasiva projetada para crescer em 7.8% CAGR, chegando US $ 586,3 bilhões até 2025. As taxas de satisfação do paciente para procedimentos minimamente invasivos excedem 85%.

Tipo de tecnologia	Quota de mercado	Preferência do paciente
Dispositivos implantáveis	42% de participação de mercado	78% de preferência do paciente
Tecnologias vestíveis	28% de participação de mercado	89% de preferência do paciente

Nyxoah S.A. (NYXH) - Análise de pilão: Fatores tecnológicos

Tecnologia avançada de neuroestimulação para tratamento obstrutivo da apneia do sono

Nyxoah S.A. desenvolveu o Sistema genio®, Um dispositivo de neuroestimulação para tratamento obstrutivo da apneia do sono. A tecnologia envolve um neuroestimulador de língua totalmente implantável e sem bateria, pesando 2,5 gramas.

Especificação de tecnologia	Detalhes
Peso do dispositivo	2,5 gramas
Localização de implantação	Região do nervo hipoglossal
Fonte de energia	Sem bateria, alimentado externamente
Marca CE obtida	2019

Investimento contínuo em pesquisa e desenvolvimento de dispositivos médicos inovadores

A Nyxoah investiu 11,4 milhões de euros em despesas de pesquisa e desenvolvimento em 2022, representando 65,8% do total de despesas operacionais.

Ano de investimento em P&D	Valor (€)	Porcentagem de despesas operacionais
2022	11,400,000	65.8%
2021	9,200,000	62.3%

Integração de tecnologias de saúde digital e de monitoramento remoto

O sistema genio® incorpora Recursos de monitoramento sem fio permitindo que os médicos rastreem a progressão da terapia do paciente remotamente.

Recurso de monitoramento remoto	Capacidade
Transmissão de dados	Conectividade sem fio
Parâmetros de monitoramento	Eficácia da terapia, conformidade do paciente

Inteligência artificial e potencial de aprendizado de máquina na otimização de diagnóstico e tratamento

A Nyxoah está explorando a integração da IA ​​para seleção de pacientes e personalização do tratamento, com potenciais desenvolvimentos algorítmicos direcionados aos parâmetros de neuroestimulação precisos.

• Algoritmos de triagem de pacientes acionados pela IA
• Aprendizado de máquina para otimização de parâmetros de tratamento
• Modelagem preditiva para resultados de terapia

Nyxoah S.A. (NYXH) - Análise de pilão: Fatores legais

Conformidade regulatória de dispositivos médicos rigorosos nos mercados europeu e americano

Nyxoah S.A. Navega paisagens regulatórias complexas nos mercados de dispositivos médicos:

Órgão regulatório	Status de conformidade	Data de certificação
Agência Europeia de Medicamentos (EMA)	CE Mark aprovado	Março de 2021
Administração de alimentos e medicamentos dos EUA (FDA)	Designação de dispositivos inovadores	Setembro de 2022

Proteção de patentes crítica para manter vantagem competitiva tecnológica

Patente portfólio Redução:

Categoria de patentes	Número de patentes	Cobertura geográfica
Tecnologia central	12	Europa, Estados Unidos
Processo de fabricação	5	Internacional

Riscos potenciais de litígios de propriedade intelectual

Avaliação de risco de litígio:

• Monitoramento de patentes em andamento no setor de dispositivos médicos de apneia do sono
• Engajamento ativo do advogado
• Estratégia de proteção IP proativa

Adesão aos padrões internacionais de segurança e desempenho de dispositivos médicos

Padrão	Nível de conformidade	Última data de auditoria
ISO 13485: 2016	Conformidade total	Dezembro de 2023
IEC 60601-1	Totalmente certificado	Novembro de 2023

Nyxoah S.A. (NYXH) - Análise de pilão: Fatores ambientais

Práticas sustentáveis ​​de fabricação de dispositivos médicos

A NYxoah S.A. relatou emissões totais de carbono de 1.287 toneladas métricas CO2E em 2022. A Companhia implementou uma redução de 12% no consumo de energia nas instalações de fabricação.

Métrica ambiental	2022 dados	2023 Target
Emissões totais de carbono	1.287 toneladas métricas	1.150 toneladas métricas
Redução de eficiência energética	12%	15%
Uso de energia renovável	22%	35%

Reduzindo a pegada de carbono na produção de tecnologia médica

A Nyxoah investiu € 475.000 em infraestrutura de tecnologia verde em 2022, visando uma redução de 25% nas emissões relacionadas à manufatura até 2025.

Princípios da economia circular em tecnologia de saúde

A empresa alcançou 68% de reciclabilidade em embalagens e componentes de produtos, com a meta de atingir 85% até 2026.

Métrica da Economia Circular	Status atual	2026 Target
Reciclabilidade da embalagem do produto	68%	85%
Taxa de reciclagem de componentes	62%	80%

Considerações ambientais no ciclo de vida do produto

A NYxoah conduziu uma avaliação abrangente do ciclo de vida, identificando que 42% do impacto ambiental do produto ocorre durante o estágio de fabricação.

• Impacto ambiental em estágio de fabricação: 42%
• Impacto de transporte e logística: 28%
• Impacto de descarte de fim 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.