- The shares of Nyxoah S.A., surged ~31% in the pre-market Monday after the Belgium-based medTech company announced that the FDA greenlighted a clinical trial to study its neurostimulation therapy Genio system for a type of sleeping disorder.
- The FDA issued Investigational Device Exemption (IDE) to initiate a clinical trial to evaluate Genio as a treatment for adults with moderate-to-severe Obstructive Sleep Apnea (OSA) and Complete Concentric Collapse (CCC) of the soft palate, the company said.
- The trial called ACCCESS is expected to involve 106 patients. The company plans to recruit the first patient in 4Q 2022 and assess the co-primary efficacy endpoints after 12 months from the implant.
- “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,” the Chief Executive of Nyxoah ( NASDAQ: NYXH ) Olivier Taelman said.
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Nyxoah jumps 31% on FDA nod to start trial for sleeping disorder