Physicians show ‘strong demand’ for the neurostimulator for obstructive sleep apnea patients, says Nyxoah CEO.
The first United States commercial obstructive sleep apnea patients have been successfully implanted with the Genio system following its FDA approval in August.
“We are thrilled to announce that the first commercial patients have now received Genio implants, marking a significant milestone in bringing this innovative therapy to OSA patients in the US,” says Olivier Taelman, CEO of Nyxoah SA, marketer of Genio, in a release. “Importantly, we have trained surgeons, obtained Value Analysis Committee approvals, and achieved successful coverage from major payors, including CMS. 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. These early leading indicators give us confidence that we’re building the right foundation for the sustained adoption of Genio moving forward.”
Andrew T. Huang, MD, FACS, director of Sleep Surgery at Baylor College of Medicine, implanted the first Genio devices at Townsen Memorial Health System in Houston, Texas. “I am excited to not only be the first surgeon to perform Genio implants commercially in the United States but to have completed my first five in one week,” he says in a release. “It was awesome to see the powerful and symmetric tongue protrusion at the end of each procedure. Like with any new procedure, there is a learning curve, but I’m excited to say the cases took me the same amount of time as my first unilateral [hypoglossal nerve stimulator] implants. The Genio system provides a solution for my patients who do not want two incisions, an implanted battery, and those where bilateral stimulation may be more beneficial to their airway anatomy.“
The company is tracking the following numbers, which it believes will serve as leading indicators of future revenue growth:
- surgeons trained;
- value analysis committee submissions made;
- prior authorization submissions; and
- accounts opened.
