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

Additional clinical data on patients suffering from Obstructive Sleep Apnea (OSA) demonstrate a clinically significant 71.0% median reduction in Apnea-Hypopnea index (AHI) while sleeping supine

at 12 months compared with baseline.

82.0% of patients who completed a polysomnography at 12 months had an AHI below 15, and 67.4% of patients who completed a polysomnography at 12 months had an AHI below 10.

Mont-Saint-Guibert, Belgium - September 27, 2024, 10:30pm CET / 4:30pm ET - Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) ("Nyxoah” or the "Company”), a medical technology company that develops breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA) through neuromodulation, announced that data from the DREAM U.S. pivotal study were presented in an oral session at the International Surgical Sleep Society (ISSS) 2024 Educational Update, taking place from September 26 -27 in Miami, Florida.

Additional data were presented for AHI reduction in supine and non-supine positions. Genio bilateral stimulation resulted in a clinically meaningful 71.0% 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 (FOSQ) assessment. Additionally, the Epworth Sleepiness Score was reduced by a mean of 3.4 points from baseline.

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 (ITT) basis. In the DREAM U.S. pivotal study, 115 patients received the Genio® implant and were included in the safety analysis. These patients had a mean AHI of 28.0, mean ODI of 27.0 and mean body mass index of 28.5 at baseline. At 12 months, 73 subjects were determined to be AHI responders, per the Sher criteria*, resulting in an ITT AHI responder rate of 63.5% (p=0.002), and 82 subjects were determined to be ODI responders, resulting in an ODI responder rate of 71.3% (p