FDA Signs Off Nyxoah's Genio Trial In Complete Concentric Collapse Patients

  • The FDA has approved Nyxoah SA's NYXH Investigational Device Exemption (IDE) to initiate a trial, called ACCCESS, to evaluate the Genio system for moderate-to-severe Obstructive Sleep Apnea (OSA) and Complete Concentric Collapse (CCC) of the soft palate. 
  • The FDA had previously granted Breakthrough Device Designation to Genio to treat CCC patients.
  • In the ACCCESS trial, Nyxoah will implant up to 106 patients with co-primary efficacy endpoints of Apnea-Hypopnea Index (AHI) and Oxygen Desaturation Index (ODI) responder rates, both assessed at 12 months post-implant.
  • The first patient is expected to be implanted during the fourth quarter of 2022, in line with prior guidance.
  • "The ACCCESS IDE approval is an important first step to unlocking an enormous patient population, as more than 30% of OSA patients in the U.S. have CCC," commented Olivier Taelman, Nyxoah's Chief Executive Officer. 
  • Nyxoah's lead solution is the Genio system, a patient-centered, leadless, and battery-free hypoglossal neurostimulation therapy for OSA.
  • Price Action: NYXH shares are up 20.20% at $9.35 during the market session on the last check Monday.
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