Nyxoah SA.
NYXH.US | Manufacture of medical and dental instruments and supplies
Nyxoah SA is a health-technology company focused on the development and commercialization of innovative solutions and services for the treatment of Obstructive Sleep Apnea (OSA). The company's lead product is the Genio system, a CE-marked, next-generation hypoglossal nerve stimulation therapy for OS...Show More
Better Health for All
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Nyxoah's sole product, the Genio system, is a leadless and battery-free hypoglossal neurostimulation therapy for moderate to severe Obstructive Sleep Apnea (OSA), a condition linked to increased mortality and cardiovascular comorbidities.
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Clinical trials demonstrate significant positive health outcomes: the DREAM study showed a 63.5% AHI responder rate and a 71.3% ODI responder rate at 12 months, with a median 70.8% AHI reduction.
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The BLAST OSA trial reported a 47.3% reduction in mean AHI and a 43.3% decrease in mean ODI at six months.
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The company has no revenue from products with negative health impacts. However, the DREAM U.S. pivotal study reported a serious adverse event (SAE) rate of 8.7% in 115 patients, with 11 SAEs in 10 subjects, including three device-related SAEs and three explants.
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The FDA document also noted a 7% overall incidence of device- and/or procedure-related SAEs up to 12-months.
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The Genio system is indicated for adults 22-75 years old with a BMI up to 32 kg/m2 and AHI 15-65, and its safety and effectiveness have not been established for patients outside these parameters or with Complete Concentric Collapse (CCC) at the soft palate level in the US.
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Despite this, the company received CE mark approval for CCC patients and is conducting trials for this subgroup.
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Reimbursement has been secured with Medicare and private payers, with a 100% approval rate on prior authorization submissions from major insurers.
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The company's R&D expenses were €12.9 million for Q3 2025, up from €7.9 million in Q3 2024,
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and it capitalized €4.9 million in development costs in 2024.
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Nyxoah provides comprehensive risk disclosures in its FDA documentation, detailing contraindications, warnings, precautions, and categorized risks.
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The company trained 111 surgeons on the Genio system as of October 31, 2025,
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and offers education programs to sleep centers and surgeons.
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Clinical trials like DREAM and BETTER SLEEP are open-label, multicenter, and authorized by regulatory authorities, with adverse events adjudicated by an independent Clinical Events Committee and safety data reviewed by an independent Data & Safety Monitoring Board.
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Fair Money & Economic Opportunity
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No evidence available to assess Nyxoah SA on Fair Money & Economic Opportunity.
Fair Pay & Worker Respect
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No evidence available to assess Nyxoah SA on Fair Pay & Worker Respect.
Fair Trade & Ethical Sourcing
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No evidence available to assess Nyxoah SA on Fair Trade & Ethical Sourcing.
Honest & Fair Business
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Nyxoah has a whistleblower policy, which includes an internal reporting channel, and references the Belgian Whistleblowing Policy.
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However, there is no evidence provided regarding the presence of a secure hotline, training frequency, program effectiveness, or independent investigation processes for reported cases.
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Kind to Animals
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Nyxoah SA performs animal testing to assess product safety.
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As a result, not a single product is certified cruelty-free.
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There is no information available regarding a formal animal testing policy, nor are there any transparent reduction targets or data on the number of animals used annually.
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No War, No Weapons
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No evidence available to assess Nyxoah SA on No War, No Weapons.
Planet-Friendly Business
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Nyxoah SA reported no significant environmental prosecutions in its 2024 Annual Report.
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Respect for Cultures & Communities
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No specific, concrete data points were found in the provided articles to assess Nyxoah SA against the 'Respect for Cultures & Communities' ethical value. The articles primarily cover corporate governance and general ESG risk scores, without detailing community engagement, cultural impact protocols, or related metrics.
Safe & Smart Tech
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Nyxoah has reported no material data breaches, violations, or unauthorized uses of IT systems or data, and no incidents are under internal review as of September 2025.
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The company has implemented and maintained commercially reasonable physical, technical, and administrative controls and safeguards.
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Nyxoah is in material compliance with all applicable state and federal data privacy and security laws, including HIPAA, and has been in compliance with GDPR since May 2018.
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Users are provided with comprehensive rights to control their personal data, including access, correction, deletion, portability, and the ability to withdraw consent.
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The company has a process for reporting potential security vulnerabilities, acknowledging reports within 5 business days, but does not have a bug bounty program.
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Nyxoah states that personal data is kept only for as long as reasonably necessary for the purposes for which it is collected, and is deleted without notice after the retention period.
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Zero Waste & Sustainable Products
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Nyxoah SA reports a 62% component recycling rate for its products.
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Additionally, 68% of the company's product packaging is recyclable.
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The company has a target to increase packaging recyclability to 85% by 2026.
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