Nyxoah marked its recent milestones by ringing the Nasdaq Closing Bell, symbolizing the company’s forward momentum as it approaches the potential US market launch of its Genio device for OSA.

Summary: Nyxoah SA rang the Nasdaq Closing Bell on Aug 29 to celebrate its recent progress and highlight upcoming milestones related to its Genio hypoglossal nerve stimulation technology. The company has submitted the final module of its Premarket Approval (PMA) application to the FDA and expects US approval by the end of 2024, with a market launch planned for early 2025. Nyxoah has also strengthened its US commercial team and secured over €85 million in funding to support the launch.

Key Takeaways:

Nasdaq Bell Ceremony Celebrates Milestones: Nyxoah rang the Nasdaq Closing Bell to commemorate its recent clinical and regulatory achievements as it prepares for the US market launch of its Genio device for obstructive sleep apnea.
Final PMA Module Submitted to FDA: Nyxoah has completed its Premarket Approval submission to the FDA, positioning the company for potential US approval of the Genio device by the end of 2024.
US Market Launch Planned for Early 2025: With FDA approval anticipated by the end of 2024, Nyxoah’s CEO says the company is on track to launch the Genio device in the US at the beginning of 2025.

Nyxoah SA, a medical technology company focused on the development of solutions to treat obstructive sleep apnea (OSA), rang the Nasdaq Closing Bell on Aug 29 to recognize the company’s recent progress and highlight upcoming milestones on its path to the US market launch of its Genio hypoglossal nerve stimulation technology for OSA.

Nyxoah has submitted the final module of its Premarket Approval (PMA) submission to the US Food and Drug Administration (FDA) and is on track for US approval by the end of 2024, according to a release from the company.

“We are honored to ring the Closing Bell and to celebrate our recent clinical and regulatory achievements in the US. We look forward with excitement to the upcoming US launch of our lead product, Genio,” says Olivier Taelman, Nyxoah’s chief executive officer, in a release. “The US is the largest healthcare market globally and therefore of strategic importance for us. With robust clinical evidence from our pivotal DREAM study, solid funding in place, and our strengthened US commercial team, we feel well-positioned to enter the US market…If approved, Genio could become available in the US as early as the beginning of 2025.”

Recent Highlights and Milestones

Recent highlights and upcoming milestones of Nyxoah’s US commercialization strategy are:

Announcement of positive data from the pivotal US study, DREAM, regarding Nyxoah’s Genio system in spring 2024.
Final module submitted in the modular PMA submission, initiating FDA interactive review.
Building a US commercial organization, headed by Scott Holstine as the new chief commercial officer, along with key sales, marketing, and market access leaders.
The US market launch of Genio is fully funded following the raising of over €85 million in growth capital through a €48.5 million equity offering and a €37.5 million loan facility agreement with the European Investment Bank.
FDA approval is expected by the end of 2024.
US market launch of Genio is planned for the beginning of 2025.

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

Additionally, the company announced positive outcomes from the DREAM IDE pivotal study for FDA and US commercialization approval. Genio is currently an investigational device in the United States.

Photo caption: NASDAQ closing bell ceremony

Photo credit: Nyxoah