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Nyxoah Shares Surge After Sleep Apnea Device Study Meets Key Goals
Shares of Nyxoah SA (Nasdaq: NYXH) surged on Thursday after the medical technology company announced its pivotal U.S. study for its sleep apnea treatment met its primary safety and efficacy goals. The positive results are a critical step toward seeking expanded U.S. regulatory approval for its flagship device.
Pivotal Study Meets Endpoints
Nyxoah reported that its ACCCESS study, which evaluated the Genio system in patients with Complete Concentric Collapse (CCC), successfully met all primary endpoints. CCC is a condition of the soft palate that currently makes patients ineligible for other commercially available hypoglossal nerve stimulation therapies in the United States.
According to the company's announcement, the key findings at the 12-month mark include:
- An Apnea-Hypopnea Index (AHI) responder rate of 77.2%.
- An Oxygen Desaturation Index (ODI) responder rate of 78.7%.
- A strong safety profile, with zero device-related serious adverse events reported.
The primary analysis was conducted on a full set of 47 patients who were implanted with the device. Nyxoah had previously closed enrollment in August 2025, ahead of its planned maximum of 106 patients, citing confidence that the existing cohort would yield statistically significant results.
AdMarket Impact and Next Steps
Investors reacted positively to the news, with Nyxoah's stock price climbing 11.9% in Thursday trading. The successful trial outcome is significant as it could open a new and previously unaddressed market segment for the company's Genio system.
Following these results, Nyxoah stated it is preparing a premarket approval (PMA) supplement to submit to the U.S. Food and Drug Administration (FDA). The company aims to expand Genio's indication to include patients with CCC, leveraging the device's FDA Breakthrough Device Designation, which can help expedite the review process.
Nyxoah plans to present the complete 12-month dataset from the ACCCESS study at the International Surgical Sleep Society annual meeting in Los Angeles on October 15-16, 2026.
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