- The FDA has approved Nyxoah SA's (NASDAQ: 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.
Read at Benzinga