Nyxoah Publishes DREAM Study Data, Highlighting Genio System's Efficacy and Safety

Nyxoah has published data from its DREAM study, showcasing the efficacy and safety of its Genio system over 12 months. The study found high patient satisfaction, consistent device usage, and significant reductions in apnea hypopnea burden and improvements in quality of life. These findings support Nyxoah's PMA submission to the FDA and position the company as a leader in innovative OSA solutions.

Nyxoah SA (Euronext Brussels/Nasdaq: NYXH), a medical technology company focused on developing innovative solutions for Obstructive Sleep Apnea (OSA), has published data from its DREAM pivotal study in the Journal of Clinical Sleep Medicine. The study, which evaluated the Genio® system over 12 months, provides comprehensive safety and efficacy results that support the company's PMA submission to the FDA.

The peer-reviewed publication reveals new data on device usage and patient satisfaction. Nightly device usage exceeded 4 hours in more than 70% of nights for 84.3% of participants who completed diary entries in the 3 months preceding the 12-month visit. Overall, the device was used on over 70% of nights by 85.9% of participants. Additionally, 90% of patients expressed satisfaction with the therapy.

The study also shows significant reductions in apnea hypopnea burden and improvements in quality of life. The snoring score, as reported by bedpartners, decreased from 83.5% at baseline to 30.4% at 12 months. Furthermore, the Functional Outcomes of Sleep Questionnaire (FOSQ) assessment increased by a mean of 2.3 points, and the Epworth Sleepiness Score was reduced by a mean of 3.4 points from baseline.

The DREAM study achieved its co-primary endpoints of 12-month AHI responder rate and Oxygen Desaturation Index (ODI) responder rate on an Intent-To-Treat (ITT) basis. The ITT AHI responder rate was 63.5% (p=0.002), and the ODI responder rate was 71.3% (p0.001). Safety results were in line with other neuromodulation therapies, with an SAE rate of 8.7%.

The findings from the DREAM study position Nyxoah as a leader in innovative OSA solutions. The high patient satisfaction and consistent usage patterns validate the company's belief that the Genio system addresses real patient needs. The significant improvement in bedpartner sleep quality demonstrates the broader impact of the technology on OSA patients and their families.

References:
[1] https://www.globenewswire.com/news-release/2025/07/28/3122839/0/en/Nyxoah-s-DREAM-Pivotal-Study-Data-Published-in-the-Journal-of-Clinical-Sleep-Medicine.html
[2] https://www.biospace.com/press-releases/nyxoahs-dream-pivotal-study-data-published-in-the-journal-of-clinical-sleep-medicine