Nyxoah SA reported a successful third quarter with clinical trial progress for its Genio neurostimulator system for the treatment of obstructive sleep apnea (OSA).

According to CEO Olivier Taelman in a release, the company plans to report data from its DREAM pivotal trial, an investigational device exemption trial designed to support the marketing authorization of the Genio neurostimulator system for OSA in the US, early next year. Shortly thereafter, the company intends to complete its modular Premarket Approval submission and hopes to receive US Food and Drug Administration approval in late 2024, says Taelman in the release. 

“Nyxoah is entering one of the most exciting times in the company’s history…Hypoglossal nerve stimulation remains highly underpenetrated and guiding patients through their OSA journey is key to unlocking the market’s potential,” Taelman says in the release.   

During the quarter, Nyxoah also initiated a commercial partnership with investor ResMed in Germany to increase OSA awareness and therapy penetration. “Our agreement with ResMed Germany, which takes ResMed from a valued investor to commercial partner, creates a continuum of care that directs patients towards the appropriate treatment, resulting in greater therapy penetration,” Taelman says in the release.  

Other recent financial and operating highlights:

  • Filed the third module in the modular Premarket Approval submission.
  • Accelerated US pre-commercialization efforts, focused on market access around CPT coding.
  • Reported third-quarter sales of €1.0 million and ended the quarter with 46 active German accounts.

Following the completion of the BLAST OSA study, the Genio system received its European CE Mark in 2019.