Nyxoah SA announced that the Company has entered into a distribution agreement with Acurable SL, a venture-backed medical device company developing wearable technologies for home use, to provide the AcuPebble SA100 home sleep test to OSA patients in Germany. The AcuPebble SA100 is a next-generation wearable home sleep test that uses acoustic signals to diagnose OSA. The patient attaches the reusable AcuPebble sensor to the base of the neck to record sounds generated by the respiratory and cardiac functions.

These recorded signals are uploaded to a secure cloud platform through a smartphone application where patented algorithms extract OSA parameters providing an automated diagnostic report within minutes. AcuPebble has demonstrated high levels of sensitivity and specificity for both the apnea-hypopnea index (AHI) and the oxygen-desaturation index (ODI) compared with the gold-standard polygraphy test, and is clinically validated through a randomized study published in the BMJ Open. The system is CE marked and has FDA clearance.