Nyxoah's Sleep Apnea Trial Meets Primary Endpoints
Nyxoah announced its BETTER SLEEP trial met primary safety and performance endpoints for the Genio® hypoglossal nerve stimulation system, showing statistically significant reductions in sleep apnea severity.
Medical technology company Nyxoah announced on June 7, 2021, that its BETTER SLEEP clinical trial met its primary safety and performance endpoints. The trial evaluated the long-term safety and performance of the Genio® system, which provides bilateral hypoglossal nerve stimulation, in 42 adult Obstructive Sleep Apnea (OSA) patients.
The trial's top-line results showed a statistically significant mean reduction in the Apnea Hypopnea Index (AHI) from baseline to six months post-implantation in the overall cohort, as well as in a subgroup of patients with Complete Concentric Collapse (CCC) of the soft palate. Approximately 42.9% of the study population had CCC.
Dr. Richard Lewis, the study's principal investigator, described the results as highly encouraging, particularly for the CCC patient subgroup, who are typically excluded from unilateral hypoglossal nerve stimulation treatments. The Genio® system demonstrated a significant AHI reduction in these patients, with the treatment being well-tolerated.
Nyxoah CEO Olivier Taelman stated the results support the company's belief in the Genio® system's potential to deliver positive clinical outcomes for CCC patients. The company plans to use these findings to expand the CE-mark indication to include CCC patients and initiate discussions with the U.S. Food and Drug Administration (FDA). Nyxoah expects to release further data as analyses are completed.