- 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.
Tesla’s Giga Berlin Hits Weekly Production Rate Of 5,000 Vehicles Since Delivering First Vehicles To European Customers, Elon Musk Says ‘Big Congratulations’
One of Tesla, Inc’s (NYSE: TSLA) newest Gigafactories has achieved a key milestone, drawing praise from none other than the company’s CEO Elon Musk.
