Nyxoah SA announced that comprehensive 12-month data from its DREAM pivotal study has been published in the Journal of Clinical Sleep Medicine, revealing new insights into patient satisfaction and device usage patterns for the Genio hypoglossal neurostimulation system in treating obstructive sleep apnea (OSA). The peer-reviewed publication provides detailed analysis supporting the company's PMA submission to the FDA.
High Patient Satisfaction and Usage Rates
The publication reveals previously unreported data showing exceptional patient adherence and satisfaction with the Genio system. Among participants completing diary entries in the three months preceding the 12-month visit, 84.3% used the device for more than four hours on greater than 70% of nights. Overall device usage exceeded 70% of nights in 85.9% of participants, with 90% of patients expressing satisfaction with the therapy.
"The high patient satisfaction and consistent usage patterns validate our belief that Genio's leadless, externally powered design addresses real patient needs," said Olivier Taelman, CEO of Nyxoah. The study also demonstrated significant improvement in bedpartner sleep quality, with patients' snoring scores reduced from 83.5% at baseline to 30.4% at 12 months.
Primary Endpoint Achievement
The DREAM U.S. pivotal study enrolled 115 patients who received the Genio implant, with participants having a mean AHI of 28.0, mean ODI of 27.0, and mean body mass index of 28.5 at baseline. The study successfully achieved its co-primary endpoints on an Intent-To-Treat basis, with 73 subjects meeting AHI responder criteria per Sher criteria, resulting in a 63.5% responder rate (p=0.002). Additionally, 82 subjects achieved ODI responder status, yielding a 71.3% responder rate (p<0.001).
"The DREAM study demonstrated efficacy of bilateral hypoglossal nerve stimulation using Genio for the treatment of obstructive sleep apnea," said B. Tucker Woodson, MD, Chief Professor at Medical College of Wisconsin and Principal Investigator of the DREAM study. "Genio demonstrated a strong effect in reducing disease burden and improving quality of life by significantly reducing the apnea hypopnea burden encouraging patient adherence and satisfaction."
Positional Efficacy and Safety Profile
The bilateral stimulation approach showed consistent efficacy across different sleeping positions. Genio achieved a clinically meaningful 66.6% median reduction in supine AHI at 12 months compared with baseline, while demonstrating a 70.8% median AHI reduction across all sleeping positions.
Safety results aligned with other neuromodulation therapies, with 11 serious adverse events occurring in ten subjects, resulting in an 8.7% SAE rate. Of these events, three were device-related, and three patients required explants.
Quality of Life Improvements
Secondary endpoint analysis revealed significant improvements in patient-reported outcomes. Participants showed a mean increase of 2.3 points in the Functional Outcomes of Sleep Questionnaire (FOSQ) assessment and a mean reduction of 3.4 points in the Epworth Sleepiness Score from baseline.
Dr. Woodson noted that "Genio's patient-centric design and bilateral HGNS stimulation offer an exciting advancement in treatment of OSA patients who fail or refuse CPAP."
Regulatory and Commercial Status
The Genio system received European CE Mark approval in 2019 following the successful BLAST OSA study. The company has expanded its therapeutic indications to include Complete Concentric Collapse (CCC) patients through the BETTER SLEEP study results. The device remains investigational in the United States, limited by federal law to investigational use pending FDA approval.
