Nyxoah, a medical technology company focused on treating obstructive sleep apnea (OSA), announced that the FDA has approved its Genio system for a portion of patients with moderate to severe OSA with an apnea-hyponea index (AHI) of greater than or equal to 15 and less than or equal to 65.
Nyxoah's Genio system, which has already received a CE mark in the EU, is a bilateral neurostimulation therapy aimed at treating moderate to severe OSA.
Genio, which is a wearable device, utilizes hypoglossal nerve stimulation as an alternative to CPAP therapy.
According to Johns Hopkins Medicine, a hypoglossal nerve stimulator is an implantable device used to treat OSA by detecting each breath and sending an electrical impulse to stimulate the nerves that move the tongue and open the airway while a person sleeps.
"Today marks a defining moment for Nyxoah and for U.S. patients suffering from OSA," Olivier Taelman, CEO of Nyxoah, said in a statement.
"With the FDA’s marketing approval of the Genio system, we are proud to bring this innovative therapy to the U.S. market. Our mission has always been to make sleep simple for OSA patients by offering them a solution that empowers better sleep. We look forward to the successful execution of our U.S. commercialization strategy."
THE LARGER TREND
Upon announcement of the FDA approval of Genio, Nyxoah's stock was trading around $7.28 per share.
On Aug. 11, Nyxoah announced preliminary earnings for the second quarter of 2025.
The company reported revenue in Q2 2025 of approximately $1.5 million (€1.3 million), a 73% increase over the second quarter of 2024.
Operating expenses for the second quarter are anticipated to be $24 million (€20.7 million), a 50% increase from the same period last year.
Cash, cash equivalents and financial assets were reported to be roughly $49.9 million (€43 million).
Nyxoah also reported a term debt facility with $31.9 million (€27.5 million) of remaining availability, which the company could be drawn down in two equal tranches subject to revenue and other financial milestones.
In addition, the company reported that it reorganized its global research and development function and expects to transition all current research and development activities from Israel to the U.S. and Belgium.
In May, Inspire Medical Systems filed a lawsuit in the United States District Court in Delaware against Nyxoah, alleging infringement of certain patents owned by Inspire.
The complaint says that Inspire filed the suit "to prevent self-proclaimed 'smart follower' Nyxoah from infringing at least three of Inspire's U.S. patents protecting Inspire's innovations in the field of neurostimulation therapy for obstructive sleep apnea (OSA)."
According to the complaint, Inspire Medical Systems claims that it brought the first FDA-approved OSA treatment to market as well as developed a neurostimulation implant for OSA patients without the need for a mask.
In the complaint, Inspire Medical Systems alleges "Nyxoah saw an opportunity to piggyback on Inspire’s success with its follow-on 'Genio' product, which also treats OSA through a neurostimulation implant. After selling Genio abroad for the past five years, Nyxoah is now preparing to launch Genio in the United States, following imminent FDA approval. But Genio infringes at least three Inspire U.S. patents."
Inspire is seeking injunctive relief and monetary damages, "including but not limited to an award of lost profits."
