Nyxoah Rings the Closing Bell at Nasdaq while Preparing for U.S. Market Launch of Innovative Sleep Apnea Device
FDA regulatory submission for the Company’s Genio® device is complete, U.S. approval on track for the end of 2024
U.S. commercial launch, expected at the beginning of 2025, fully funded with over €85 million in new capital raised
Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) , a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA), rang the Nasdaq Closing Bell on August 29, 2024 to recognize the Company’s recent progress and highlight upcoming milestones on its path to the U.S. market launch of its innovative patient-centric Genio® hypoglossal nerve stimulation technology for OSA, a prevalent and severe sleep-related breathing disorder associated with increased mortality risk and cardiovascular comorbidities.
“We are honored to ring the Closing Bell to celebrate our recent clinical and regulatory achievements in the U.S. and look forward with excitement to the upcoming U.S. launch of our lead product, Genio,” commented Olivier Taelman, Nyxoah’s Chief Executive Officer. “The U.S. 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. We have submitted the final module of our PMA submission to the FDA and expect a decision by the end of 2024. If approved, Genio could become available in the U.S. as early as the beginning of 2025.”
Recent Highlights and Upcoming Milestones of Nyxoah’s U.S. Commercialization Strategy
- Announcement of positive data from the pivotal U.S. study, DREAM, regarding Nyxoah’s Genio® system, an innovative hypoglossal neurostimulation therapy for Obstructive Sleep Apnea (OSA) in spring 2024.
- Final module submitted in the modular PMA submission, initiating FDA interactive review.
- Building a U.S. commercial organization, headed by Scott Holstine as the new Chief Commercial Officer along with key sales, marketing and market access leaders.
- The U.S. market launch of Genio® is fully funded following the successful 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 (EIB).
- FDA approval expected approval by US Food and Drug Administration by the end of 2024.
- U.S. market launch of Genio® planned for the beginning of 2025.
To view the broadcast of the Nasdaq Closing Bell ceremony, please visit: https://www.nasdaq.com/news-and-insights/nasdaq-stock-market-bell-ceremonies
