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- 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.
Crypto Whales Are Loading Up — Are You?
New research shows the biggest crypto buyers are back. And this time? They could hold for the possibility that Bitcoin will surpass $100,000 in 2024. You don’t want to miss the next massive crypto bull run like we saw in 2020 and 2021. To know exactly what’s going on and what to buy… Get Access To Benzinga’s Best Crypto Research and Investments For Only $1.
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