Nyxoah

What Nyxoah does

Nyxoah SA is a Belgian medical technology company that develops and commercializes the Genio system, a bilateral hypoglossal nerve stimulation (HGNS) therapy for moderate-to-severe obstructive sleep apnea (OSA) in adults who have failed, refused, or cannot tolerate CPAP. The system consists of a battery-free, leadless implantable neurostimulator placed under the chin in a single-incision outpatient procedure, a disposable adhesive sleep wearable that powers the implant nightly, and a patient-facing smartphone app for therapy control and usage tracking. Genio received CE Mark in 2019 and FDA Premarket Approval in August 2025, supported by the DREAM pivotal trial demonstrating a 63.5% AHI responder rate and 70.8% median AHI reduction.

Nyxoah operates a direct enterprise sales model, with a 40-representative US field sales force targeting hospitals and ambulatory surgical centers, complemented by reference accounts in the Netherlands (OLVG West, Zuyderland) and the Middle East (Saudi German Hospital Dubai). The company sells the implantable device and recurring disposable patch consumables, reimbursed under CPT code 64568 with Medicare hospital outpatient payment of approximately $45,000 and ASC payment of $42,373 under the CY2026 rule. Genio is the company's sole commercial product; pricing is not publicly disclosed but the company reports 100% prior-authorization approval on reviewed commercial payer submissions.

Nyxoah is dual-listed on Euronext Brussels (since September 2020) and Nasdaq under ticker NYXH (since July 2021), headquartered in Mont-Saint-Guibert, Belgium with a US office in Summit, New Jersey, and reports 101-250 employees. The company has funded US and international commercialization through multiple public offerings and a €37.5M EIB loan facility, with €36-40M of FY2026 worldwide net revenue guided by management. Strategic investors Cochlear and ResMed participated in a $77M November 2025 financing, and a $110M capital raise (BofA-led $95M equity plus $15M EIB tranche) closed in June 2026. The current CEO, Olivier Taelman, is leading a planned transition to a US-based CEO as the company enters its next US-driven growth phase.

Name

Nyxoah

Legal name

Nyxoah SA

Website

https://nyxoah.com

Company type

Public

Founded year

2009

Operating status

Operating

Headcount range

101–250 employees

Short description

Nyxoah is a Belgian medical device company that develops and commercializes the Genio system, a bilateral hypoglossal nerve stimulation therapy for adults with moderate-to-severe obstructive sleep apnea who cannot tolerate CPAP, selling through direct hospital and ASC channels in the US, Europe, and the Middle East.

Ownership category

akta.pro rank

Headquarters

HQ city

Mont-saint-guibert

HQ country

Belgium

HQ region

Europe

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Marketing or Sales, Supply Chain, Operations

Revenue model

1. Genio System Sales: Revenue generated from commercial sales of the Genio hypoglossal nerve stimulation system, including the implantable device and disposable components (wearable patches). The company achieved Q1 2026 global net revenue of €6.4 million with 25% sequential quarterly growth in U.S. net revenue (€4.3 million).
2. Reimbursement Coverage: 100% prior-authorization approval rate on reviewed commercial payer submissions. Hospital outpatient reimbursement increased by approximately 48% to $45,000 under Medicare CY2026 rule. ASC facility reimbursement increased by 58% to $42,373.

Go-to-market motion2 records

Distribution channels2 records

Marketing channels5 records

Core offering

Nyxoah develops and commercializes the Genio system, a leadless, battery-free bilateral hypoglossal nerve stimulation (HGNS) therapy implant for treating moderate to severe obstructive sleep apnea (OSA) in adult patients who have failed, refused, or cannot tolerate CPAP therapy. The system comprises an implantable stimulator placed under the chin in a single-incision outpatient procedure, a disposable external wearable adhesive patch that powers the implant nightly, and a patient-facing smartphone app for therapy control and usage tracking.

Product overview

Nyxoah is a medical technology company focused on treating obstructive sleep apnea (OSA). The company's sole product is the Genio System, a comprehensive hypoglossal nerve stimulation therapy consisting of three integrated components: (1) a battery-free implantable neurostimulator that is inserted under the chin in a single-incision outpatient procedure, (2) a disposable sleep wearable patch with external activation chip that powers the implant nightly, and (3) a smartphone app that allows patients to control stimulation within predefined settings and track device usage. Genio received CE Mark approval in 2019 and FDA PMA approval in August 2025 for adult patients with moderate to severe OSA (AHI 15-65) who have not tolerated, failed, or refused CPAP therapy. The therapy works by bilateral stimulation of the hypoglossal nerve to contract tongue muscles and maintain airway patency during sleep.

Differentiator

Problem solved

Functional benefit

Brands

• Genio: FDA-approved and CE-Mark validated bilateral neurostimulation therapy system for treating moderate to severe obstructive sleep apnea (OSA).

Products and services

• Genio System A patient-centered, leadless, and battery-free hypoglossal neurostimulation therapy system for treating moderate to severe obstructive sleep apnea (OSA). Includes an implantable battery-free stimulator, a disposable sleep wearable patch with activation chip, and a smartphone app. Designed for adult OSA patients (AHI 15-65) who are not significantly overweight and have not tolerated, failed, or refused CPAP/PAP therapy. The system works through bilateral stimulation of the hypoglossal nerve to keep the airway open during sleep.

Quantifiable outcome

• 63.5% AHI responder rate in clinical trials
• +6 more outcomes

Named customers4 records

Segments1 record

Ideal customer profiles1 record

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature6 records

Partnerships

One partnership is on record.

• JD Lymon GroupcoreImplementation/ SI/ Consulting PartnerIndependent reimbursement consulting firm engaged to present on U.S. reimbursement landscape at investor events. Advises on Medicare and commercial payer coverage strategies.

Scale indicators17 records

Recent moves7 records

Expansion highlights6 records

Broad incumbents

• Fisher & Paykel Healthcare:
• ResMed: ResMed is the global leader in sleep-disordered breathing and CPAP therapy. While focused on PAP rather than HGNS, ResMed is a Nyxoah investor and serves the same OSA patient pool, making it both a complementary incumbent and a strategic partner with deep distribution in sleep clinics.
• Koninklijke Philips: Philips is a major player in sleep and respiratory care through its DreamStation and other CPAP/APAP product lines. It operates broadly in the same OSA therapy market, overlapping with Nyxoah on patient population but not on the implantable HGNS modality.

Direct peers

• Inspire Medical Systems: Inspire Medical Systems is the leading U.S. provider of hypoglossal nerve stimulation therapy for OSA with its Inspire UAS system. It is Nyxoah's most direct competitor, addressing the same CPAP-intolerant patient population with an implantable neurostimulator and has multi-year incumbency advantages in U.S. payer coverage and surgeon networks.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights8 records

Customer concentration

• Facebookfacebook.com/nyxoah
• Instagraminstagram.com/geniosleep
• Xx.com/nyxoah
• LinkedInlinkedin.com/company/nyxoah-sa

Revenue estimate

Valuation estimate

Number of profiles

Profiles15 records

Funding overview

Funding rounds13 records

Investors6 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Nyxoah