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Last updated : 19/10/2026 - 15h24
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Nyxoah lowers its 2026 revenue forecast to 33-35 M€ despite 29% rise in US sales over the quarter

Nyxoah published on October 19, 2026 preliminary and unaudited figures for the third quarter of 2026 that confirm the growing weight of the American market in its sales. The Belgian specialist in neuromodulation implants for obstructive sleep apnea simultaneously lowered its revenue forecast for the 2026 fiscal year, now between 33 and 35 M€ compared to 36 to 40 M€ previously, an announcement released as privileged information.

The publication comes a few days after the presentation on October 15, 2026 of the 12-month results of the American pivot study ACCESS. It is accompanied by the filing with the FDA of a request to expand the indication of the Genio implant in the United States. On the stock market, the share showed a 65.56% decline over twelve months as of September 29, 2026.


Nyxoah lowers its 2026 revenue forecast to 33-35 M€ despite 29% rise in US sales over the quarter

Quarterly revenue of 9.2 M€, up 19% from the second quarter

For the third quarter of 2026, Nyxoah projects global net revenue of approximately 9.2 M€, up 19% compared to the second quarter of 2026. The company presents this data as preliminary and unaudited.

The United States contributed approximately 6.7 M€ to this total. Net American revenue increased by 29% from one quarter to the next, a rate higher than that of the group as a whole. The American market thus represents the majority of the quarter's sales and accounts for most of the sequential growth.

342 trained surgeons and 233 active accounts in the United States

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Beyond revenue, the company communicated what it presents as leading commercial indicators for the American market. During the third quarter, 80 new surgeons were trained in Genio implantation, bringing the total to 342.

At the same time, 53 new accounts were activated, for a total of 233 active high-volume accounts. Finally, 447 patients were undergoing prior authorization procedures as of the entry into the fourth quarter.

These three data points describe the diffusion mechanism of an implantable device: the number of trained surgeons and active facilities conditions the capacity to perform implantations, while prior authorization files constitute a reservoir of identified patients for the following months.

An application filed with the FDA to expand the indication for Genio

On the regulatory front, Nyxoah submitted to the FDA a supplement to its premarket approval application (PMA) to expand the American indication for Genio to patients presenting complete concentric collapse (CCC). This application is based on the American pivot study ACCESS.

According to the company, this study met its primary efficacy criteria and safety criteria in CCC patients, with a responder rate at 12 months of 77.2% measured on the apnea-hypopnea index. These complete results were presented on October 15, 2026 at the annual congress of the International Surgical Sleep Society in Los Angeles.

The company also adjusted its revenue forecast for the 2026 fiscal year. Prior to this publication, the seven analysts tracked anticipated on average revenue of 37 M€ for the current fiscal year, in a range of 36 M€ to 38 M€. The structuring figure of the quarter remains the 29% increase in American sales, to approximately 6.7 M€.

Related


Sector Dispositifs médicaux et optique › Dispositifs médicaux


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Context

Period
  • Period: T3 2026
Key reported figures
  • Revenue: 9,2 millions d'euros
  • Quarterly revenue: 9,2 millions d'euros
  • Revenue growth: 366,5 %
Guidance from the release
  • Bien que nous soyons déçus d'ajuster nos prévisions de chiffre d'affaires
Risks mentioned
  • Ajustement à la baisse des prévisions de chiffre d'affaires (de 36-40 M€ à 33-35 M€)
  • Trajectoire de croissance inférieure aux attentes pour l'exercice 2026
  • Dépendance à la ramp-up des États-Unis reflétant les cycles historiques d'une nouvelle technologie
Opportunities identified
  • Supplément PMA soumis à la FDA pour étendre l'indication américaine aux patients atteints de collapsus concentrique complet
  • Croissance séquentielle de 29 % du chiffre d'affaires aux États-Unis au T3 2026
  • Expansion du nombre de chirurgiens formés (342 cumulés) et comptes activés (233 à fort volume) aux États-Unis
Outlook / guidance
  • Expected revenue: 34 millions d'euros
  • Management commentary: The Company now expects global net revenue for the full year 2026 to be in the range of €33 million to €35 million, compared to €36 million to €40 million previously.

The information presented in this article is provided for informational purposes only and does not constitute an investment recommendation, an incentive to buy or sell a financial asset, or investment advice. Readers are invited to conduct their own research before making any decision.

Investments in the stock market involve risks, including the risk of capital loss. Past performance of an asset or market is no guarantee of future results. Any investment decision should be made taking into account your personal financial situation, objectives and risk tolerance.

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