DREAM Pivotal Study Data Presented at the International Surgical Sleep Society 2024 Educational Update

Core Insights - Nyxoah SA presented additional clinical data from the DREAM U.S. pivotal study at the International Surgical Sleep Society 2024 Educational Update, highlighting significant efficacy in treating Obstructive Sleep Apnea (OSA) through the Genio® device [2][5] Group 1: Clinical Efficacy - The study demonstrated a clinically significant 71.0% median reduction in the Apnea-Hypopnea Index (AHI) for patients sleeping in a supine position at 12 months compared to baseline [1][2] - 82.0% of patients who completed polysomnography at 12 months had an AHI below 15, while 67.4% had an AHI below 10 [1][2] - The overall median AHI reduction across all sleeping positions was 70.8% at 12 months [2] Group 2: Quality of Life Improvements - Significant improvements in quality-of-life outcomes were reported, with a mean increase of 2.3 points in the Functional Outcomes of Sleep Questionnaire (FOSQ) [3] - The Epworth Sleepiness Score decreased by a mean of 3.4 points from baseline, indicating reduced daytime sleepiness [3] Group 3: Study Results and Safety - The study achieved its co-primary endpoints, with an AHI responder rate of 63.5% and an Oxygen Desaturation Index (ODI) responder rate of 71.3% on an Intent-To-Treat (ITT) basis [4] - Out of 115 patients, 73 were classified as AHI responders, and 82 were ODI responders at 12 months [4] - Safety results were consistent with other neuromodulation therapies, reporting an SAE rate of 8.7% with 11 serious adverse events [4] Group 4: Company Progress and Future Plans - Nyxoah is progressing toward FDA approval for the Genio® system, which is seen as a significant milestone for making the device available to OSA patients in the U.S. [5] - The company has previously received CE Mark approval for the Genio® system in Europe and has completed successful IPOs on Euronext Brussels and NASDAQ [6][7]