Key Takeaways
- Nyxoah’s DREAM study revealed a 71% median reduction in the AHI among obstructive sleep apnea patients after 12 months, showcasing the effectiveness of the Genio device.
- Patients in the DREAM study reported significant quality of life improvements, with a 2.3-point increase in the FOSQ and reduced daytime sleepiness.
- Nyxoah is advancing toward FDA approval for its Genio device, aiming to make this innovative OSA treatment widely accessible in the U.S. following its successful clinical outcomes.
Nyxoah SA, a pioneering medical technology company, has unveiled groundbreaking data from its DREAM U.S. pivotal study, showcasing significant advancements in the treatment of obstructive sleep apnea (OSA). The results, presented at the International Surgical Sleep Society 2024 Educational Update in Miami, reveal clinically meaningful reductions in the Apnea-Hypopnea Index (AHI) and substantial improvements in patients’ quality of life.
The DREAM study data highlight a 71.0% median reduction in AHI among patients sleeping in a supine position after 12 months compared to baseline. This reduction is in line with a 70.8% median AHI reduction across all sleeping positions. Impressively, 82.0% of patients who underwent polysomnography at 12 months reported an AHI below 15, while 67.4% had an AHI below 10. These results underscore the efficacy of Genio’s bilateral hypoglossal nerve stimulation in managing obstructive sleep apnea.
DREAM Study Confirms Genio’s Efficacy and Quality of Life Improvements in Obstructive Sleep Apnea Treatment
Secondary endpoints also demonstrated notable improvements. Patients reported a mean increase of 2.3 points in the Functional Outcomes of Sleep Questionnaire (FOSQ) and a reduction of 3.4 points in the Epworth Sleepiness Score from baseline, indicating enhanced quality of life and reduced daytime sleepiness.
The DREAM study also achieved its co-primary endpoints, with a 63.5% AHI responder rate and a 71.3% Oxygen Desaturation Index (ODI) responder rate based on Intent-To-Treat (ITT) criteria. Among the 115 patients who received the Genio implant, safety outcomes were comparable to other neuromodulation therapies, with an 8.7% serious adverse event (SAE) rate.
Dr. B. Tucker Woodson, Chief Professor at the Medical College of Wisconsin and Principal Investigator of the DREAM study noted, “The study confirms the efficacy of Genio in treating OSA, showing significant improvements in both primary and secondary endpoints. Genio could revolutionize neuromodulation therapy for obstructive sleep apnea patients.”
Nyxoah’s Genio Poised for FDA Approval, Offering New Hope for Obstructive Sleep Apnea Patients in the U.S.
Olivier Taelman, CEO of Nyxoah, emphasized, “These results validate our patient-centric approach, showing significant AHI reductions and quality of life improvements. We are advancing towards FDA approval, a crucial step in making Genio accessible to obstructive sleep apnea patients in the U.S.”
Nyxoah continues to innovate in the field of sleep apnea treatment with its Genio device, a battery-free hypoglossal neuromodulation device. Following its European CE Mark approval in 2019 and successful IPOs, the company is poised for further growth with the positive outcomes of the DREAM IDE pivotal study, paving the way for U.S. commercialization.
With the continuous advancements in the treatment of obstructive sleep apnea, patients can look forward to more effective and less invasive solutions. The promising results from the DREAM study suggest that Genio may significantly improve patient outcomes and overall quality of life. As Nyxoah progresses toward FDA approval, the potential for widespread adoption of this innovative device in the U.S. market appears increasingly likely, offering new hope for those suffering from obstructive sleep apnea.
Resource: Nyxoah SA, September 27, 2024
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