Belgium-based Nyxoah SA expects to see full-year revenue for 2023 increase approximately 41% over the previous year, primarily driven by the rising demand for its CE-marked Genio system, a neurostimulation therapy for obstructive sleep apnea (OSA).

The Genio system has been CE-marked since 2019. The system is an investigational device in the United States.

“This anticipated growth reflects both strong underlying demand for Genio and focus on streamlining the patient referral pathway through initiatives such as our direct-to-consumer online campaigns launched in March,” says Olivier Taelman, CEO, in a release. 

Preliminary, unaudited fourth-quarter and full-year 2023 results:

  • Revenue for the fourth quarter of 2023 is anticipated to be approximately €1.8 million, a 40% increase over the fourth quarter of 2022 and an 87% increase over the third quarter of 2023.
  • Revenue for the full year 2023 is anticipated to be approximately €4.3 million, a 41% increase over the full year 2022.
  • Ended the year with 48 active German accounts.

Following the completion of the BLAST OSA study, the Genio system received its CE mark. 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 patients, currently contraindicated in competitors’ therapy.

Nyxoah is currently conducting the DREAM IDE pivotal study for FDA and U.S. commercialization approval.

“This performance throughout 2023 sets the stage for an exciting 2024, as in a few months we expect to report data from our DREAM US pivotal trial, file for FDA approval, begin preparations to enter the US market, and begin to see contribution from the ResMed commercial partnership in Germany.”