Nyxoah advances its US launch plans for the Genio system, which recently achieved positive co-primary endpoints in the DREAM US pivotal study.
Summary: Nyxoah reported its Q1 2024 financial and operating results, highlighting significant progress with its Genio system, a leadless and battery-free hypoglossal neurostimulation therapy for obstructive sleep apnea (OSA). The DREAM US pivotal study achieved co-primary endpoints, demonstrating strong efficacy in reducing the apnea-hypopnea index (AHI) in supine and non-supine positions. Nyxoah is preparing the final FDA Premarket Approval module and reported a 170% increase in quarterly sales to €1.2 million. Additionally, Maurits S. Boon, MD, was appointed chief medical officer.
Key Takeaways:
- Nyxoah’s DREAM US pivotal study for the Genio system achieved co-primary endpoints, showing a significant reduction in apnea hypopnea index (AHI) in both supine and non-supine positions, underscoring the system’s efficacy.
- Nyxoah is preparing the final module for FDA Premarket Approval of the Genio system, marking a critical step toward its US market launch.
- Nyxoah reported a 170% increase in Q1 2024 sales, reaching €1.2 million, alongside appointing Maurits S. Boon, MD, as chief medical officer to strengthen their leadership team.
Belgium-based Nyxoah SA, a medical technology company focused on developing solutions for obstructive sleep apnea (OSA), reported first-quarter highlights, showcasing progress with its lead solution, the Genio system.
Genio, a leadless and battery-free hypoglossal neurostimulation (HGNS) therapy for OSA, has received the CE Mark in Europe.
Q1 Highlights
During the quarter, the company reported the DREAM US pivotal study achieved co-primary endpoints on an intent-to-treat basis and demonstrated strong apnea hypopnea index (AHI) reductions in supine and non-supine sleep positions.
The DREAM study achieved a median AHI reduction of 70.8%, a 12-month AHI responder rate, per the Sher criteria, of 63.5% (p=0.002) on an intention-to-treat 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.
