Nyxoah's DREAM Study Shows Promising Results for OSA Treatment
Nyxoah's DREAM Study Overview
Nyxoah SA has recently made headlines with their stellar presentation of the DREAM pivotal study data, showcasing significant advancements in tackling Obstructive Sleep Apnea (OSA) during the International Surgical Sleep Society's educational session. The comprehensive data underscores how the innovative Genio device is changing the landscape for patients suffering from this troubling condition.
Clinical Findings Highlighted
The results reveal a remarkable median reduction of 71.0% in the Apnea-Hypopnea Index (AHI) for patients sleeping in the supine position after 12 months of therapy compared to baseline. This statistic is particularly noteworthy, indicating that the Genio therapy is not only effective but also provides a real improvement in the quality of sleep for many individuals.
Additionally, a significant 82.0% of patients who completed a polysomnography at the 12-month mark had an AHI below 15. Even more impressively, 67.4% achieved an AHI below 10. These statistics speak volumes about the effectiveness of the Genio device, allowing more people to experience healthier sleep, which is critical for overall well-being.
Presenting at the ISSS Educational Update
The presentation at the International Surgical Sleep Society (ISSS) 2024 awaited the fall event in Miami, emphasizing the clinical relevance of the findings. This worldwide platform allowed Nyxoah to share insights from their pivotal study, emphasizing the transformational potential of their neuromodulation approaches in treating OSA.
Effectiveness Across Sleep Positions
A key aspect of the study revolves around the device’s performance based on sleep positions. It was noted that while there was a reported 71.0% median reduction in AHI for patients sleeping supine, there was also a notable median reduction of 70.8% observed across all sleeping positions at the 12-month follow-up. This comprehensive approach showcases the device's versatility and efficacy.
Quality of Life Enhancements
In addition to the primary efficacy measures, the study reported secondary improvements concerning quality of life. Patients exhibited a mean increase of 2.3 points in the Functional Outcomes of Sleep Questionnaire (FOSQ) assessment, while the Epworth Sleepiness Score was reduced by an average of 3.4 points, reflecting a sizeable enhancement in their daily lives. These measures further highlight how medical advancements can directly affect a patient’s quality of life.
Genio and Future Prospects
Dr. B. Tucker Woodson, the study's principal investigator at the Medical College of Wisconsin, commented on the transformative efficacy of Genio therapy. He remarked on the clinically significant outcomes observed, suggesting that Genio harbors the potential to successfully advance neuromodulation therapies for OSA treatment.
Olivier Taelman, CEO of Nyxoah, shared an optimistic outlook about their approach in the field of OSA treatment. By consistently achieving significant AHI reductions, the company validates its patient-centric approach while amassing tangible results that promise to enhance the quality of life for countless individuals.
About Nyxoah
Nyxoah is reinventing solutions for the vast population suffering from OSA. Their flagship innovation, the battery-free Genio device, is a testament to their commitment to developing practical and effective therapies through neuromodulation. This device is positioned for easy integration into surgical practices, marking a significant leap forward in OSA treatment methodologies.
With their CE Mark obtained in 2019, following the successful BLAST OSA study, Nyxoah's credibility in the medical technology space continues to rise. The company has impressively listed on both Euronext Brussels and NASDAQ, solidifying its presence on global stages as they continue to push for FDA approval for the Genio device—a highly anticipated milestone in their mission to aid OSA patients.
Frequently Asked Questions
What is the DREAM study about?
The DREAM study is a pivotal clinical trial focusing on the effectiveness of Nyxoah's Genio device in treating Obstructive Sleep Apnea (OSA).
What results were presented at the ISSS event?
The study showcased a 71.0% median reduction in Apnea-Hypopnea Index (AHI) and significant quality-of-life improvements for participants after 12 months.
How does the Genio device work?
The Genio device is a battery-free hypoglossal neuromodulation system that effectively stimulates upper airway muscles to prevent sleep apnea events.
What are the future plans for Genio?
Nyxoah aims to obtain FDA approval for the Genio device, marking a critical step in making this treatment accessible to U.S. patients.
Who to contact for more information?
For inquiries, individuals can reach out to Nyxoah's Chief Financial Officer, Loïc Moreau, via the provided contact information.
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