NYXOAH S.A. (NYXH): Analyse du pilon [Jan-2025 MISE À JOUR]

Dans le paysage rapide de la technologie médicale en évolution, Nyxoah S.A. Cette analyse complète du pilon dévoile les facteurs externes multiformes qui façonnent la trajectoire stratégique de l'entreprise, des obstacles réglementaires en Europe aux percées technologiques en neurostimulation. Plongez dans une exploration complexe de la façon dont les dynamiques politiques, économiques, sociologiques, technologiques, juridiques et environnementales convergent pour influencer le chemin révolutionnaire de cette entreprise médicale pour transformer les soins aux patients et le potentiel du marché.

NYXOAH S.A. (NYXH) - Analyse du pilon: facteurs politiques

Société de technologie médicale basée en Belgique dans des environnements réglementaires complexes

Nyxoah S.A. opère dans des paysages politiques et réglementaires complexes sur les marchés européens de la santé. La société doit naviguer dans plusieurs cadres réglementaires pour maintenir la conformité et l'accès au marché.

Autorité réglementaire	Statut de conformité réglementaire	Date de certification
Agence européenne des médicaments (EMA)	CE Mark approuvé	Septembre 2021
Administration américaine de l'alimentation et du médicament (FDA)	Désignation de dispositif révolutionnaire	Novembre 2020

Règlement sur les dispositifs médicaux de l'Union européenne

Règlement sur les dispositifs médicaux (MDR) 2017/745 a un impact significatif sur le développement de produits et les stratégies de marché de Nyxoah.

• Exigences de preuves cliniques strictes
• MANDATIONS DE SURVEILLANCE POST-CARCHÉT
• Protocoles complets de gestion des risques

Tensions géopolitiques dans le commerce des technologies médicales

Région	Indice de complexité commerciale	Barrières réglementaires
Union européenne	Bas (2,3 / 10)	Minimal
États-Unis	Moyen (5,7 / 10)	Modéré

Changements de politique de santé dans les marchés cibles

Nyxoah surveille en permanence les développements de la politique des soins de santé sur les principaux marchés pour adapter les stratégies d'expansion du marché.

• Politiques de remboursement de la Belgique pour les dispositifs médicaux
• Mécanismes de financement de l'innovation des soins de santé européens
• Règlement sur les investissements en technologie médicale internationale

Marché	Impact de la politique des soins de santé	Complexité potentielle de l'entrée du marché
Belgique	Solidaire	Faible
Allemagne	Modérément restrictif	Moyen
États-Unis	Environnement réglementaire complexe	Haut

NYXOAH S.A. (NYXH) - Analyse du pilon: facteurs économiques

Technologies de traitement de la croissance du secteur MedTech et du sommeil

Le marché mondial des appareils d'apnée du sommeil était évalué à 6,2 milliards de dollars en 2022 et devrait atteindre 9,8 milliards de dollars d'ici 2030, avec un TCAC de 6,2%.

Performance financière et dépenses de santé

Nyxoah S.A. a déclaré un chiffre d'affaires total de 5,1 millions d'euros pour l'exercice 2022, avec des dépenses de R&D de 16,4 millions d'euros.

Métrique financière	Valeur 2022	Valeur 2021
Revenus totaux	5,1 millions d'euros	2,8 millions d'euros
Dépenses de R&D	16,4 millions d'euros	12,6 millions d'euros
Perte nette	20,1 millions d'euros	15,3 millions d'euros

Fluctuations économiques mondiales et financement de la R&D

Les investissements en capital-risque en technologie médicale ont totalisé 16,3 milliards de dollars en 2022, ce qui représente une baisse de 36% par rapport à 25,4 milliards de dollars de 2021.

Risques de change

Paire de devises	Volatilité du taux de change (2022)	Impact sur les revenus
EUR / USD	6,5% de fluctuation	± 0,3 million d'euros
EUR / GBP	4,2% de fluctuation	± 0,2 million d'euros

Le remboursement de l'assurance des soins de santé pour les traitements d'apnée du sommeil a augmenté de 4,3% en 2022, atteignant environ 2,1 milliards de dollars dans le monde.

NYXOAH S.A. (NYXH) - Analyse du pilon: facteurs sociaux

L'augmentation de la sensibilisation mondiale aux troubles du sommeil stimulant la demande du marché

Selon la World Sleep Society, 45% de la population mondiale éprouve des troubles liés au sommeil. Le marché mondial des troubles du sommeil était évalué à 456,9 milliards de dollars en 2022 et devrait atteindre 647,7 milliards de dollars d'ici 2030.

Type de trouble du sommeil	Prévalence mondiale	Impact du marché
Apnée obstructive du sommeil	22% de la population	Segment de marché de 214,3 milliards de dollars
Insomnie	10 à 30% des adultes	Segment de marché de 132,6 milliards de dollars

La population vieillissante et la hausse des taux d'obésité élargissent la base de patients potentiels

Population mondiale âgée de 65 ans et plus 1,5 milliard D'ici 2050. Les taux d'obésité dans le monde ont augmenté à 13% en 2022, en corrélation directement avec la prévalence des troubles du sommeil.

Groupe d'âge	Risque de trouble du sommeil	Population potentielle de patients
65-74 ans	Risque 40% plus élevé	382 millions de patients potentiels
Plus de 75 ans	Risque à 55% plus élevé	276 millions de patients potentiels

Consommation de santé croissante mettant l'accent sur les solutions de traitement non invasives

Le marché des dispositifs médicaux non invasifs devrait atteindre 274,6 milliards de dollars d'ici 2027, avec 67% des patients préférant des traitements peu invasifs.

Changer les préférences des patients vers les technologies médicales mini-invasives

Marché de la technologie médicale mini-invasif qui devrait croître à 7.8% CAGR, atteignant 586,3 milliards de dollars d'ici 2025. Les taux de satisfaction des patients pour les procédures mini-invasives dépassent 85%.

Type de technologie	Part de marché	Préférence des patients
Dispositifs implantables	Part de marché de 42%	78% de préférence des patients
Technologies portables	28% de part de marché	89% de préférence des patients

Nyxoah S.A. (NYXH) - Analyse du pilon: facteurs technologiques

Technologie avancée de neurostimulation pour le traitement d'apnée du sommeil obstructif

Nyxoah S.A. Système Genio®, un dispositif de neurostimulation pour le traitement obstructif sur l'apnée du sommeil. La technologie implique un neurostimulateur de langue sans batterie entièrement implantable pesant 2,5 grammes.

Spécifications technologiques	Détails
Poids de dispositif	2,5 grammes
Emplacement d'implantation	Région du nerf hypoglossal
Source d'énergie	Sans batterie, à alimentation externe
CE Mark obtenue	2019

Investissement continu dans la recherche et le développement de dispositifs médicaux innovants

Nyxoah a investi 11,4 millions d'euros dans les frais de recherche et de développement en 2022, ce qui représente 65,8% du total des dépenses d'exploitation.

Année d'investissement de R&D	Montant (€)	Pourcentage des dépenses d'exploitation
2022	11,400,000	65.8%
2021	9,200,000	62.3%

Intégration des technologies numériques de la santé et de la surveillance à distance

Le système Genio® intègre capacités de surveillance sans fil Permettre aux médecins de suivre à distance la progression du traitement des patients.

Fonction de surveillance à distance	Capacité
Transmission de données	Connectivité sans fil
Paramètres de surveillance	Efficacité de la thérapie, conformité des patients

Intelligence artificielle et potentiel d'apprentissage automatique dans l'optimisation du diagnostic et du traitement

Nyxoah explore l'intégration d'IA pour la sélection et la personnalisation du traitement des patients, avec des développements algorithmiques potentiels ciblant des paramètres de neurostimulation précis.

• Algorithmes de dépistage des patients dirigés par l'IA
• Apprentissage automatique pour l'optimisation des paramètres de traitement
• Modélisation prédictive pour les résultats de la thérapie

NYXOAH S.A. (NYXH) - Analyse du pilon: facteurs juridiques

Conformité réglementaire stricte sur les dispositifs médicaux sur les marchés européens et américains

Nyxoah S.A. navigue des paysages réglementaires complexes sur les marchés des dispositifs médicaux:

Corps réglementaire	Statut de conformité	Date de certification
Agence européenne des médicaments (EMA)	CE Mark approuvé	Mars 2021
US Food and Drug Administration (FDA)	Désignation de dispositif révolutionnaire	Septembre 2022

Protection des brevets critique pour maintenir un avantage concurrentiel technologique

Répartition du portefeuille de brevets:

Catégorie de brevet	Nombre de brevets	Couverture géographique
Technologie de base	12	Europe, États-Unis
Processus de fabrication	5	International

Risques potentiels de litige en matière de propriété intellectuelle

Évaluation des risques de litige:

• Surveillance des brevets en cours dans le secteur des dispositifs médicaux de l'apnée du sommeil
• Engagement actif des conseils juridiques
• Stratégie de protection IP proactive

Adhésion aux normes de sécurité et de performance des dispositifs médicaux internationaux

Standard	Niveau de conformité	Dernière date d'audit
ISO 13485: 2016	Compliance complète	Décembre 2023
IEC 60601-1	Entièrement certifié	Novembre 2023

NYXOAH S.A. (NYXH) - Analyse du pilon: facteurs environnementaux

Pratiques de fabrication de dispositifs médicaux durables

Nyxoah S.A. a rapporté des émissions totales de carbone de 1 287 tonnes métriques CO2E en 2022. La société a mis en œuvre une réduction de 12% de la consommation d'énergie entre les installations de fabrication.

Métrique environnementale	2022 données	Cible 2023
Émissions totales de carbone	1 287 tonnes métriques CO2E	1 150 tonnes métriques CO2E
Réduction de l'efficacité énergétique	12%	15%
Consommation d'énergie renouvelable	22%	35%

Réduire l'empreinte carbone dans la production de technologie médicale

Nyxoah a investi 475 000 € dans l'infrastructure de technologies vertes en 2022, ciblant une réduction de 25% des émissions liées à la fabrication d'ici 2025.

Principes d'économie circulaire dans la technologie des soins de santé

L'entreprise a obtenu 68% de recyclabilité dans l'emballage et les composants des produits, dans le but d'atteindre 85% d'ici 2026.

Métrique de l'économie circulaire	État actuel	Cible 2026
Recyclabilité des emballages de produits	68%	85%
Taux de recyclage des composants	62%	80%

Considérations environnementales dans le cycle de vie des produits

Nyxoah a effectué une évaluation complète du cycle de vie, identifiant que 42% de l'impact environnemental des produits se produit pendant le stade de fabrication.

• Impact environnemental de la phase de fabrication: 42%
• Impact du transport et de la logistique: 28%
• Impact d'élimination de fin de vie: 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.