The latest announcement is out from Nyxoah ( (NYXH) ).
Nyxoah announced that the FDA has issued an approvable letter for its Genio® system, indicating that the company’s premarket approval application largely meets regulatory requirements. This milestone brings Nyxoah closer to commercializing its innovative OSA therapy in the U.S., pending satisfactory inspection of manufacturing facilities. The decision does not affect the Genio® system’s CE marking or ongoing commercial activities in Europe, where it is already approved for patients with complete concentric collapse.
More about Nyxoah
Nyxoah operates in the medical technology sector, focusing on developing and commercializing innovative solutions for Obstructive Sleep Apnea Syndrome (OSA). The company’s primary product is the Genio® system, a leadless and battery-free hypoglossal nerve stimulation therapy designed to treat OSA, a common sleep breathing disorder associated with increased mortality and comorbidities. Nyxoah has successfully completed IPOs on Euronext Brussels and NASDAQ and has received CE marking for its Genio® system in Europe.
YTD Price Performance: 25.33%
Average Trading Volume: 47,596
Technical Sentiment Signal: Strong Sell
Current Market Cap: $391.6M
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