Genio by Nyxoah: status and timeline

Milestones

Next · Reimbursement coverage expands beyond sleep centers

CE Mark (European) approval2021Complete.
European commercial launch2022Complete.
FDA approval for obstructive sleep apneaAug 2025Complete.
US commercial launch and adoptionSep 2025Complete.
Series C funding closesJun 2026Complete.
15% market share penetration in leading US accountsJun 2026Complete.

Most important updates

Nyxoah raises $95M equity financing plus $15M EIB loan to accelerate US Genio commercializationJun 2026
FDA approves Genio hypoglossal nerve stimulator for obstructive sleep apneaAug 2025

Upcoming

2026Reimbursement coverage expands beyond sleep centers (next)
2027Post-market data confirms long-term durability
2027Price competition with Inspire intensifies

Current obstacles

Surgical placement and revisionImplantation requires a small incision under the chin; some patients experience infection, bleeding, or displacement requiring repositioning.
Patient selection complexityAnatomical factors (airway collapsibility, baseline patency, tongue position) affect outcome; better pre-operative screening improves success rates.
Market competitionInspire Medical is established in sleep apnea HNS; gaining share requires proven outcomes and cost advantage.

Physics limits

Not suitable for all apnea phenotypesPatients with purely central apnea (brain's failure to signal breathing), severe positional apnea, or anatomically fixed narrowing may not benefit from HNS.
Battery depletionThe implanted battery lasts 7–10 years; device replacement requires another surgery, limiting device lifespan unless wireless charging or higher energy density batteries improve.
Habituation possibleSome patients develop tolerance to stimulation over time as the nervous system adapts, which may require periodic adjustments or increased stimulation levels.

How it works

4 parts

Electrode Placement

Subcutaneous under chin

Small electrode placed under skin of chin, positioned to contact the hypoglossal nerve. Battery also placed subcutaneously.

Nerve Stimulation

Electrical pulses during sleep

During sleep, device detects breathing and delivers timed pulses to hypoglossal nerve, causing tongue to contract forward.

Airway Clearance

Tongue movement opens airway

Tongue moves forward and upward, enlarging airway and preventing soft palate and tongue collapse.

Sleep Synchrony

Adaptive to sleep and wake

Device senses sleep and stops stimulation when awake, allowing normal swallowing and speech.

Spec sheet

Spec	Genio
Implant form factor	Single small device under the chin^R (reported)
Treatment efficacy	Reduces apnea-hypopnea index by 50%+ in majority of patients^R (reported)
Expected device lifespan	7+ years^E (estimated)
US market share (early accounts)	15%^R (reported)

^R reported by the company · ^E our estimate

Update log

2 updates

Jun 2026

Major: Nyxoah raises $95M equity financing plus $15M EIB loan to accelerate US Genio commercializationPressFunding

Aug 2025

Major: FDA approves Genio hypoglossal nerve stimulator for obstructive sleep apneaFilingRegulatory

About Nyxoah

The team behind Genio

Nyxoah

Genio hypoglossal nerve stimulator, sleep apnea, HNS

Nyxoah develops Genio, an implantable hypoglossal nerve stimulator for sleep apnea. FDA-approved August 2025; bilateral stimulation via single subcutaneous implant with external wearable power control. Strong early US adoption.

Bilateral nerve stimulation from single subcutaneous implant; external wearable component provides power.
FDA approved August 2025. Achieved 15% market share in early adopter accounts.
June 2026: $95M equity round plus $15M EIB loan. Liam Kelly became CEO October 2026.

nyxoah.com (opens nyxoah.com)Company profile →

Founded: 200917 yrs
Headquarters: Belgium
Status: Public
Valuation: $250Mest. privateJun 2026estimate
Staff: ~200Jan 2026
Raised: $139M3 rounds
Last round: Equity financing · $95MJun 2026
Works in: NeurotechStimulation therapies
Coverage: 1 program · 2 updateslatest 1 Jun 2026checked 11 Oct
Lead investors: Existing and new investorsCochlear LimitedResMed Inc
People: Liam KellyCEO

Spec

Genio

Implant form factor

Single small device under the chin^R (reported)

Treatment efficacy

Reduces apnea-hypopnea index by 50%+ in majority of patients^R (reported)

Expected device lifespan

7+ years^E (estimated)

US market share (early accounts)

15%^R (reported)