After years of being cleared on the European market, Nyxoah’s neuromodulation therapy for obstructive sleep apnea has now claimed an FDA approval. The company is preparing to start its U.S. rollout—but it may run into a legal roadblock.
The company’s Genio system—designed as an alternative to nightly CPAP—received a green light for patients with moderate to severe cases of the condition, defined by a person’s difficulty breathing tallied on an hourly basis through a measurement known as the apnea-hypopnea index.
Genio includes a small, battery-free nerve stimulation implant that’s powered by an external device worn during sleep, and controlled with a smartphone app. The system delivers bilateral electric pulses to the hypoglossal nerves that control the muscles of the tongue and keep it clear of the airway.
In Nyxoah’s pivotal trial, the device delivered an overall median reduction in the apnea-hypopnea index of about 71%, and 82% of all participants saw their scores drop into at least the mild range, regardless of their sleeping position.
The latter is an important point, according to the company, because while people sleep on their back between 35% and 40% of the night on average, airway obstructions typically double during that time.
“Today marks a defining moment for Nyxoah and for U.S. patients suffering from OSA. With the FDA’s marketing approval of the Genio system, we are proud to bring this innovative therapy to the U.S. market,” Nyxoah CEO Olivier Taelman said in a statement Aug. 8. “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.”
That strategy may be complicated by a patent infringement lawsuit filed by rival developer Inspire Medical on May 30.
Inspire is seeking an injunction in Delaware federal court that would bar the Belgium-based Nyxoah from the U.S. market, claiming the Genio system runs afoul of three of its neurostimulation patents.
Inspire received an FDA approval in 2014 for its pacemaker-like approach, with a pulse generator implanted near the collarbone and leads that connect it to the hypoglossal nerves as well as a breathing sensor. Its label was expanded by the agency in 2023.
In a statement, Nyxoah said it “is well prepared, has the means and intends to vigorously defend itself in this matter.”
Meanwhile, earlier this year, Inspire disclosed that it is the subject of a civil false claims investigation by the Department of Justice, which is looking into reimbursements from Medicare and Medicaid.
This week, Nyxoah also offered a preliminary look at its quarterly earnings, posting 1.3 million euros of revenue, or about $1.5 million U.S., for a 73% increase over last year’s second quarter.
Operating expenses, meanwhile, are set to top 20 million euros, for a 50% increase. The company also said it had restructured its global operations, and “expects to transition all ongoing R&D activities from Israel to the U.S. and Belgium.”
“We are pleased with the growth we saw in the second quarter, which provides further evidence that our commercial proof of concept in Germany has been successful,” said Taelman, with Genio obtaining a European CE mark in 2019. “With FDA approval in hand, we expect to take the lessons learned from Germany and apply them to the U.S. as we bring our unique Genio system to the U.S.”