Summary: Nyxoah SA presented additional data from its DREAM US study on the Genio neurostimulation system for treating obstructive sleep apnea (OSA) at the 2024 International Surgical Sleep Society (ISSS) Educational Update, which showed that Genio’s bilateral stimulation resulted in a 71% median reduction in apnea-hypopnea index (AHI) for patients sleeping in a supine position at 12 months. The overall AHI reduction across all sleep positions was 70.8%. Secondary outcomes included improvements in quality of life and reduced daytime sleepiness. Safety outcomes were comparable to other neuromodulation therapies, with low rates of serious adverse events.
Three Key Takeaways:
- Significant AHI Reductions: The Genio neurostimulation system achieved a 71% median reduction in AHI in supine positions, compared to 70.8% across all sleeping positions after 12 months.
- Quality of Life Improvements: Patients showed a 2.3-point improvement in the Functional Outcomes of Sleep Questionnaire and a 3.4-point reduction in the Epworth Sleepiness Score, indicating better sleep quality and reduced sleepiness.
- Safety Consistent with Neuromodulation Therapies: The study reported 11 serious adverse events (SAEs) in 10 subjects, with three device-related SAEs and three explants, comparable to other neuromodulation treatments.
Nyxoah SA, maker of the CE-marked Genio neurostimulation system for the treatment of obstructive sleep apnea (OSA), presented additional data from the DREAM US study in an oral session at the International Surgical Sleep Society (ISSS) 2024 Educational Update, showing the Genio implant reduced patients’ apnea-hypopnea index (AHI) in supine and non-supine positions.
Genio bilateral stimulation resulted in a clinically meaningful 71% median reduction in supine AHI at 12 months compared with baseline. This reduction compares to a median 12-month AHI reduction of 70.8% across all sleeping positions.
With respect to secondary endpoints reported at ISSS, subjects demonstrated significant improvements in quality-of-life outcomes. Specifically, a mean increase of 2.3 points was observed in the Functional Outcomes of Sleep Questionnaire assessment. Additionally, the Epworth Sleepiness Score was reduced by a mean of 3.4 points from baseline.
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The presentation included previously announced data demonstrating that the study achieved its co-primary endpoints of 12-month AHI responder rate, per the Sher criteria, and Oxygen Desaturation Index (ODI) responder rate, both on an Intent-to-Treat basis.
Dream US Pivotal Study
In the DREAM US pivotal study, 115 patients received the Genio implant and were included in the safety analysis. These patients had a mean AHI of 28, mean ODI of 27, and mean body mass index of 28.5 at baseline. At 12 months, 82% of patients who completed a polysomnography had an AHI below 15, and 67.4% of patients who completed a polysomnography had an AHI below 10.
Safety results were in line with other neuromodulation therapies, with 11 serious adverse events, or SAEs, in 10 subjects resulting in an SAE rate of 8.7%. Out of the 11 SAEs, three were device-related, and there were three explants.
“The DREAM study demonstrated efficacy of bilateral hypoglossal nerve stimulation using Genio for the treatment of obstructive sleep apnea. Clinically significant improvements in primary and secondary endpoints were observed,” says B. Tucker Woodson, MD, chief, professor at Medical College of Wisconsin, and principal investigator of the DREAM study, in a release. “Genio has the potential of helping us advance neuromodulation therapy for the treatment of OSA.”
Olivier Taelman, CEO of Nyxoah, adds in a release, “Achieving meaningful AHI reductions regardless of sleep position is a clinical validation of our patient-centric approach. Genio bilateral stimulation also enabled more than 80% of patients to hit 12 months with an AHI below 15, positively impacting their overall quality of life and reducing sleepiness. Nyxoah is now entering the final regulatory phase and is progressing toward FDA approval. This will be a huge milestone in our mission to make Genio available to OSA patients in the US.”
Photo caption: Genio
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