Nyxoah (Nasdaq:NYXH) announced today that it received FDA approval for its Genio neuromodulation device for treating sleep apnea.
Genio utilizes an implanted electrode around the hypoglossal nerve, stimulating the tongue and keeping the airway open. The unique design utilizes bilateral stimulation and offers patients a leadless, full-body 1.5T and 3T MRI-compatible, non-implanted battery powered and controlled by a wearable component. This fully upgradeable wearable component provides access to the technology without requiring additional surgeries for technology updates or battery replacements, according to Nyxoah.
Mont-Saint-Guibert, Belgium-based Nyxoah received approval for a subset of patients with moderate to severe obstructive sleep apnea (OSA). These patients have an Apnea-Hypopnea Index (AHI) of greater than or equal to 15 and less than or equal to 65.
FDA approval means Nyxoah can bring its own OSA neuromodulation system to the market to battle current leader Inspire Medical. The two companies are already embroiled in a patent spat, according to Inspire’s latest earnings report.
Companies like LivaNova and XII Medical also aim to take share in this market. They all offer an alternative for the traditional continuous positive airway pressure (CPAP) machines. Resmed currently has a leg up in that market after Philips’ Respironics recall saga. (Resmed also took part in a Nyxoah funding round in 2020.)
“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,” said Olivier Taelman, Nyxoah CEO. “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.”
How Nyxoah earned its FDA nod
The company said data from its DREAM pivotal trial supported the Genio system’s FDA approval. The study met both its primary and secondary endpoints.
Nyxoah said Genio demonstrated an AHI responder rate of 63.5% and an Oxygen Desaturation Index responder rate of 71.3%. It also had an overall median AHI reduction of 70.8%. Additionally, 82.% of all DREAM subjects saw their AHI scores drop below 15 or lower.
The company said DREAM demonstrated the system’s efficacy, regardless of patient’s sleeping position. It says this makes it the only therapy with such clinical evidence in a large, multicenter, prospective clinical study using data from a full night polysomnography.
“The Genio system’s approval represents a major addition to the treatment options available to physicians treating patients with OSA,” said Dr. Colin Huntley associate professor, Department of Otolaryngology Head & Neck Surgery, Thomas Jefferson University. “This unique bilateral stimulation technology has demonstrated consistent efficacy across all sleeping positions, including the challenging supine position, while maintaining an excellent safety profile.”
