Nasdaq-listed shares of Nyxoah SA (NYXH) soared 13% on Monday morning after the company announced that the first U.S commercial patients with Obstructive Sleep Apnea (OSA) have been successfully implanted with its Genio system.

OSA is a common sleep disorder where the upper airway repeatedly collapses during sleep, leading to breathing pauses. It is associated with increased mortality risk and comorbidities, including cardiovascular diseases, depression, and stroke.

Nyxoah's Genio therapy is a mask-free treatment option and works by gently stimulating hypoglossal nerves to contract muscles on both sides of the tongue, keeping the airway open throughout the night. The Genio System features a battery-free stimulator that's externally powered by a sleep wearable, with customizable settings. It provides an alternative to CPAP therapy, which uses a machine to deliver pressurized air through a mask, keeping the airway open during sleep and preventing breathing pauses.

Nyxoah CEO Olivier Taelman said that the company has also trained surgeons, obtained Value Analysis Committee (VAC) approvals, and achieved successful coverage from major payors.

“What's also particularly encouraging is the strong demand we're seeing from physicians, with surgeons actively reaching out for training opportunities, many of whom already have patients lined up for implants,” he added.

The Genio system received approval from the U.S. Food and Drug Administration in August for a subset of patients with moderate to severe OSA. The approval was supported by a trial that demonstrated Genioi's efficacy regardless of a patient's sleeping position.

NYXH stock is down by 30% this year and by about 40% over the past 12 months. 

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