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  • The DEKRA Notified Body has approved the use of Nyxoah SA’s NYXH next-generation Genio 2.1 system for patients in Europe. 
  • Genio 2.1 is a patient-centered, leadless, and battery-free hypoglossal neurostimulation therapy for Obstructive Sleep Apnea.
  • As with the recent approval of Genio 2.1 by the FDA for use in the DREAM U.S. IDE pivotal study, this CE mark pertains entirely to the external components of the Genio system. 
  • Related: FDA Signs Off Nyxoah’s Genio Trial In Complete Concentric Collapse Patients.
  • It will be available to all patients who have received Genio implants.
  • Genio 2.1 is designed to improve patient comfort and compliance with a new smartphone application and upgraded external activation chip. 
  • Genio 2.1 offers patients daily feedback on therapy usage and the autonomy to adjust stimulation amplitude within pre-defined boundaries. 
  • Physicians can fine-tune stimulation amplitude to determine the optimal comfort level for patients without compromising therapy efficacy. 
  • Additional embedded sensors will allow physicians to further tailor therapy stimulation parameters based on patient position and throughout the night. 
  • Price Action: NYXH shares closed 1.69% higher at $9.00 on Monday.

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