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Nyxoah Announces Commercial Launch of Genio® Breakthrough Therapy in the Netherlands

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Nyxoah (Nasdaq: NYXH) announced the commercial launch of its Genio bilateral neurostimulation system in the Netherlands on December 17, 2025.

First successful Genio implants were performed at OLVG West (Amsterdam) and Zuyderland Hospital (Heerlen). Management said the system offers bilateral nerve stimulation, no implanted battery, full-body 1.5T and 3T MRI compatibility, and an externally powered activation chip that enables upgrades. Nyxoah described the launch as a step in its European rollout and said early implants validate Genio as a long-term CPAP alternative for patients who cannot tolerate CPAP.

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Positive

  • Commercial launch in the Netherlands on December 17, 2025
  • First successful implants at OLVG West and Zuyderland Hospital
  • Device features: no implanted battery, bilateral stimulation
  • Full-body 1.5T and 3T MRI compatibility
  • Externally powered activation chip allows future upgrades

Negative

  • None.

News Market Reaction

%
1 alert
% News Effect
$207M Market Cap
0.1x Rel. Volume

On the day this news was published, NYXH declined NaN%, reflecting a moderate negative market reaction.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

MRI field strength: 1.5T MRI field strength: 3T
2 metrics
MRI field strength 1.5T Genio system full-body MRI compatibility
MRI field strength 3T Genio system full-body MRI compatibility

Market Reality Check

Price: $4.43 Vol: Volume 7,530 is well belo...
low vol
$4.43 Last Close
Volume Volume 7,530 is well below the 20-day average 48,135 (relative volume 0.16). low
Technical Price $4.80 is trading below the 200-day MA $6.64, indicating a pre-news downtrend.

Peers on Argus

Peers show mixed moves: AVR +5.32%, INFU +1.53%, while OSUR -3.20% and others ar...

Peers show mixed moves: AVR +5.32%, INFU +1.53%, while OSUR -3.20% and others are slightly down, suggesting today’s Nyxoah news is stock-specific rather than a sector-wide driver.

Historical Context

5 past events · Latest: Dec 02 (Neutral)
Pattern 5 events
Date Event Sentiment Move Catalyst
Dec 02 Transparency filing Neutral -0.7% Voting-rights transparency notifications showing modest increase in reported holdings.
Nov 27 Conference participation Neutral +2.8% Announcement of management fireside chat at a major healthcare conference.
Nov 20 Capital structure update Neutral +1.5% Disclosure of updated share capital, voting rights, and subscription rights figures.
Nov 13 Financing package Negative -9.8% Multi-part financing with equity offerings and convertible bond facility to fund growth.
Nov 13 Earnings update Negative -9.8% Q3 2025 results showing revenue growth but significant operating loss and cash usage.
Pattern Detected

Recent financing and earnings updates with losses and capital raises were followed by negative price reactions, while neutral corporate disclosures saw modest moves.

Recent Company History

Over the last months, Nyxoah reported Q3 2025 results with €2.0M revenue, 60.5% gross margin and an operating loss of €24.4M, alongside expanding surgeon training and early reimbursement wins. On November 13, 2025, the company secured up to U.S. $77M in financing via equity and convertible notes to support Genio commercialization. Subsequent disclosures focused on updated voting-rights figures and transparency notifications. This announcement adds a new step in Genio’s commercial rollout in Europe, complementing those earlier financing and operating milestones.

Market Pulse Summary

This announcement marks further commercialization of Nyxoah’s Genio system, with initial implants at...
Analysis

This announcement marks further commercialization of Nyxoah’s Genio system, with initial implants at OLVG West in Amsterdam and Zuyderland Hospital in Heerlen. The news builds on prior financing and Q3 updates that detailed revenue growth, operating losses, and capital raises to support U.S. and international rollout. Investors may focus on how quickly Dutch centers adopt Genio, the impact on revenue relative to past quarters, and ongoing execution of broader European and U.S. commercialization plans.

Key Terms

obstructive sleep apnea, neuromodulation, cpap, bilateral neurostimulation, +1 more
5 terms
obstructive sleep apnea medical
"treatment alternatives for Obstructive Sleep Apnea (OSA) through neuromodulation"
Obstructive sleep apnea is a common medical condition where the throat repeatedly narrows or closes during sleep, causing short pauses in breathing, drops in blood oxygen and fragmented rest. It matters to investors because it creates ongoing demand for medical devices, diagnostics, treatments and sleep-monitoring services, and it can affect population health, workforce productivity and healthcare spending—like a recurring leak in a system that requires continual repair and monitoring.
neuromodulation medical
"treatment alternatives for Obstructive Sleep Apnea (OSA) through neuromodulation"
Neuromodulation is the use of devices or targeted treatments to change how nerves or brain circuits send signals, much like adjusting the volume or tuning on an audio system to alter what you hear. For investors, it matters because these therapies can treat chronic conditions (pain, movement disorders, depression) where existing medicines fall short, creating potential markets, regulatory milestones, and durable revenue streams if technologies prove safe and effective.
cpap medical
"additional treatment option for OSA when CPAP is not tolerated"
A CPAP (continuous positive airway pressure) device is a machine that gently blows a steady stream of air through a mask to keep a person’s breathing passages open during sleep, commonly used to treat sleep apnea. For investors, CPAPs matter because they represent a medical-device market with recurring sales of equipment and disposable supplies, subject to safety reviews, insurance reimbursement rules and regulatory approvals that can affect a maker’s revenue and reputation.
bilateral neurostimulation medical
"Introducing the Genio bilateral neurostimulation system expands our ability"
Bilateral neurostimulation is a medical treatment that delivers controlled electrical or magnetic pulses to corresponding areas on both sides of the brain or paired nerves to alter their activity. Investors care because it represents a therapeutic approach with potential to treat conditions such as movement disorders, chronic pain, or depression; successful trials, regulatory approval, or device uptake can drive sales and affect the financial outlook for companies developing these technologies.
mri-compatible medical
"is full body 1.5 and 3T MRI-compatible, and can be easily upgraded"
MRI-compatible describes a medical device, implant, or accessory that is safe to be placed in or near an MRI scanner and will not move, heat up, or interfere with the images produced by the machine. For investors, MRI compatibility is important because it expands a product’s usable market, reduces regulatory and liability risks, and can increase adoption by hospitals and patients — similar to making an electronic gadget that reliably works on any airline flight.

AI-generated analysis. Not financial advice.

Nyxoah Announces Commercial Launch of Genio® Breakthrough Therapy in the Netherlands
First Genio implants successfully performed at OLVG West and Zuyderland hospitals

Mont-Saint-Guibert, Belgium – December 17, 2025, 7:05am CET / 1:05am ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), a medical technology company that develops breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA) through neuromodulation, today announced the commercial launch of its Genio® system in the Netherlands, marked by the first successful Genio implants performed at OLVG West in Amsterdam and Zuyderland Hospital in Heerlen.

Commenting on the introduction of Genio in Amsterdam, Dr. Peter van Maanen, ENT surgeon at OLVG West, stated: “Dr. Mayke Hentschel, our sleep department and I are pleased to offer our patients an additional treatment option for OSA when CPAP is not tolerated. With Genio, patients finally have a real choice. The system stimulates both branches of the nerve, has no internal battery, is full body 1.5 and 3T MRI-compatible, and can be easily upgraded via the external activation chip. These features make it a promising long-term solution for both patients and healthcare providers.”

At Zuyderland Hospital, Dr. Jos Straetmans, ENT surgeon in Heerlen and Sittard, added: “Introducing the Genio bilateral neurostimulation system expands our ability to tailor therapy to the needs of each individual patient. Its advantages: no implanted battery, and reliable performance in the supine position make it a valuable addition to our treatment arsenal. We are excited to bring this innovative, European developed technology to patients in our community.”

“The commercial launch of Genio in the Netherlands marks another important step in our European rollout and reflects growing adoption of our bilateral, externally powered Genio therapy,” commented Olivier Taelman, Nyxoah's Chief Executive Officer. “We are proud to partner with leading Dutch centers to bring Genio to patients seeking an effective and patient-centric alternative to CPAP. As we continue to expand our commercial footprint, these early implants further validate Genio’s role as a long-term solution for OSA.”

About Nyxoah

Nyxoah is a medical technology company focused on the development and commercialization of innovative solutions to treat OSA. Nyxoah’s lead solution is the Genio system, a patient-centric, leadless and battery-free hypoglossal neurostimulation therapy for OSA, the world’s most common sleep disordered breathing condition that is associated with increased mortality risk and cardiovascular comorbidities. Nyxoah is driven by the vision that OSA patients should enjoy restful nights and feel enabled to live their life to its fullest.

Following the successful completion of the BLAST OSA study, the Genio system received its European CE Mark in 2019. Nyxoah completed two successful IPOs: on Euronext Brussels in September 2020 and NASDAQ in July 2021. Following the positive outcomes of the BETTER SLEEP study, Nyxoah received CE mark approval for the expansion of its therapeutic indications to Complete Concentric Collapse (CCC) patients, currently contraindicated in competitors’ therapy. Additionally, the Company announced positive outcomes from the DREAM IDE pivotal study and receipt of approval from the FDA for a subset of adult patients with moderate to severe OSA with an AHI of greater than or equal to 15 and less than or equal to 65.

For more information, please visit http://www.nyxoah.com/.

Caution – CE marked since 2019. FDA approved in August 2025 as prescription-only device.

Forward-looking statements

Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company’s or, as appropriate, the Company directors’ or managements’ current expectations regarding the Genio system; the potential advantages of the Genio system; Nyxoah’s goals with respect to the potential use of the Genio system; the Company's commercialization strategy and entrance to the U.S. market; and the Company's results of operations, financial condition, liquidity, performance, prospects, growth and strategies. By their nature, forward-looking statements involve a number of risks, uncertainties, assumptions and other factors that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties, assumptions and factors could adversely affect the outcome and financial effects of the plans and events described herein. These risks and uncertainties include, but are not limited to, the risks and uncertainties set forth in the “Risk Factors” section of the Company’s Annual Report on Form 20-F for the year ended December 31, 2024, filed with the Securities and Exchange Commission (“SEC”) on March 20, 2025 and subsequent reports that the Company files with the SEC. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward-looking statements contained in this press release regarding past trends or activities are not guarantees of future performance and should not be taken as a representation that such trends or activities will continue in the future. In addition, even if actual results or developments are consistent with the forward-looking statements contained in this press release, those results or developments may not be indicative of results or developments in future periods. No representations and warranties are made as to the accuracy or fairness of such forward-looking statements. As a result, the Company expressly disclaims any obligation or undertaking to release any updates or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward- looking statements are based, except if specifically required to do so by law or regulation. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person's officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.

Contacts:

Nyxoah
John Landry, CFO
IR@nyxoah.com

Rémi Renard
Chief Investor Relations & Corporate Communication Officer
IR@nyxoah.com

Attachment


FAQ

What did Nyxoah announce about Genio in the Netherlands on December 17, 2025?

Nyxoah announced the commercial launch of Genio and reported the first successful implants at OLVG West and Zuyderland Hospital.

Which hospitals performed the first Genio implants in the Netherlands for NYXH?

The first reported Genio implants were performed at OLVG West (Amsterdam) and Zuyderland Hospital (Heerlen).

What are Genio's key device features mentioned for NYXH patients?

Genio provides bilateral nerve stimulation, has no implanted battery, is 1.5T/3T MRI-compatible, and uses an external activation chip.

How does Nyxoah position Genio for patients who cannot tolerate CPAP (NYXH)?

Nyxoah positions Genio as a patient-centric, long-term alternative for OSA patients who do not tolerate CPAP.

Does Genio require an implanted battery according to Nyxoah's announcement (NYXH)?

No; the announcement states Genio has no internal implanted battery and is externally powered.
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