Summary: Nyxoah described its Q1 2024 economic and operating outcomes, highlighting sizeable progress with its Genio program, a leadless and battery-cost-free hypoglossal neurostimulation therapy for obstructive snooze apnea (OSA). The Aspiration US pivotal study reached co-key endpoints, demonstrating powerful efficacy in minimizing the apnea-hypopnea index (AHI) in supine and non-supine positions. Nyxoah is preparing the final Fda Premarket Approval module and noted a 170% enhance in quarterly income to €1.2 million. Also, Maurits S. Boon, MD, was appointed main professional medical officer.
Important Takeaways:
- Nyxoah’s Aspiration US pivotal research for the Genio procedure accomplished co-most important endpoints, demonstrating a considerable reduction in apnea hypopnea index (AHI) in equally supine and non-supine positions, underscoring the system’s efficacy.
- Nyxoah is getting ready the closing module for Fda Premarket Acceptance of the Genio method, marking a significant stage towards its US sector launch.
- Nyxoah claimed a 170% boost in Q1 2024 profits, achieving €1.2 million, alongside appointing Maurits S. Boon, MD, as main medical officer to reinforce their management group.
Belgium-based Nyxoah SA, a healthcare technological innovation enterprise targeted on establishing answers for obstructive snooze apnea (OSA), reported very first-quarter highlights, showcasing development with its guide remedy, the Genio procedure.
Genio, a leadless and battery-absolutely free hypoglossal neurostimulation (HGNS) remedy for OSA, has acquired the CE Mark in Europe.
Q1 Highlights
Throughout the quarter, the company documented the Dream US pivotal study accomplished co-major endpoints on an intent-to-take care of basis and shown strong apnea hypopnea index (AHI) reductions in supine and non-supine sleep positions.
The Desire examine accomplished a median AHI reduction of 70.8%, a 12-month AHI responder fee, per the Sher criteria, of 63.5% (p=.002) on an intention-to-handle basis, and a 12-month ODI responder rate of 71.3% (p<0.001) on an intention-to-treat basis.
The company is preparing the fourth and final Premarket Approval module for submission this quarter.
“The DREAM US study achieving its primary endpoints is a pivotal milestone for Nyxoah and further differentiates Genio as the only HGNS therapy to demonstrate strong efficacy in supine and non-supine OSA. With the DREAM data in hand, our US launch preparations are focused on attracting commercial talent to set us up for success when we introduce Genio,” says Olivier Taelman, Nyxoah chief executive officer, in a release. “With continued European commercial traction, positive DREAM data, and a highly differentiated, patient-centric HGNS solution, I could not be more excited for Nyxoah’s future.”
Additionally, during the first quarter, Nyxoah appointed Maurits S. Boon, MD, as chief medical officer, and quarterly sales reached €1.2 million, showing 170% growth versus Q1 2023.
Leave a Reply