The Genio system, developed by the American company Nyxoah, has been implanted in the first patients in the United States after being officially approved by the U.S. Food and Drug Administration (FDA). This groundbreaking implant aims to help treat obstructive sleep apnea (OSA), offering an alternative to traditional CPAP masks.
The treatment of obstructive sleep apnea may finally become simpler, especially for patients who struggle with using traditional CPAP machines and masks. Nyxoah has announced that the first patients have successfully undergone implantation procedures with the Genio system — a new technology designed to make nighttime breathing easier without the need for a mask.
The Genio system implantations were performed at Townsen Memorial Health System in Houston, Texas, by Dr. Andrew T. Huang, MD FACS, Director of Sleep Surgery at Baylor College of Medicine. He emphasized that both the simplicity of the implantation and its effectiveness left a very positive impression on him.
So how exactly does the Genio system work? It operates through hypoglossal nerve stimulation, which prevents airway obstruction during sleep. The activator placed under the patient’s chin powers the implant and stimulates the nerve, gently moving the tongue forward. This prevents the airway from collapsing, allowing the patient to breathe freely throughout the night.
It’s worth noting that Genio implants have been officially approved by the U.S. Food and Drug Administration (FDA) after many years of research and clinical testing. This is especially important for conditions like OSA, as it means we’re dealing with a proven and reliable therapy using verified medical equipment — not an experimental gadget that could have various side effects.
Unlike other popular solutions on the market (such as implants from Inspire Medical Systems), Genio does not contain a battery. Instead, it uses an external activator that is placed under the chin during sleep. This means the patient doesn’t have to worry about having a battery inside their body or about future replacement surgeries. In traditional implants, the battery typically needs to be replaced approximately every 10 years.
Genio implants offer several advantages over traditional CPAP machines with masks. They allow patients to travel without carrying bulky equipment, improve sleep comfort (since one can sleep in any position without worrying about the mask), and eliminate noise that could disturb family members. It’s also one of the few solutions available for people who cannot tolerate CPAP therapy for various reasons.
The Genio implantation procedure itself is minimally invasive — it requires only a single incision under the chin. The manufacturer also highlights that Genio is compatible with MRI scans and can be updated without needing to remove the implant from under the skin.
After receiving approval from the U.S. Food and Drug Administration (FDA), Nyxoah has begun the active commercialization of the Genio system in the United States. The company also reports that it is already training surgeons and building a network of clinics where patients will be able to access this Genio implant therapy.
