Medical-technology company Nyxoah identified obstructive sleep apnea as a critical market due to vast patient need and the limitations of current treatment options. This prompted the Belgian company to develop a new device that treats the sleep disorder.
“One of our primary motivators was the high patient dropout rate associated with airway pressure therapy, the standard first-line treatment for obstructed sleep apnea,” says Olivier Taelman, CEO of Nyxoah. “This clear unmet need to develop some patient-centric solution led us to create a minimally invasive neurostimulation device.”
Nyxoah’s innovative design for its Genio device could be a big development for the estimated 14% of men and 7% of women who suffer from moderate to severe sleep apnea.
The standard treatment with “continuous positive airway pressure” machines require wearing an uncomfortable mask throughout the night. Many patients aren’t able to tolerate the treatment, finding it uncomfortable or it disturbs their sleep. Half of users drop the treatment within a few years.
The European Investment Bank recognised Genio’s potential to transform sleep apnea treatment and invested €37.5 million in July 2024 to support further research and development and to scale-up production.
“Our neurostimulation technology, designed to enhance comfort and compliance, will enable patients to experience a higher quality of life through an effective, patient-friendly solution that addresses a significant unmet medical need,” says Taelman.
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What is obstructive sleep apnea?
Obstructive sleep apnea causes a person’s breathing repeatedly to stop and start, because of blockage in the airways. This is often caused by the collapse of soft tissue in the throat.
Clinical studies have shown that the mortality rate of non-treated patients suffering from OSA increases significantly over time. Untreated obstructive sleep apnea is associated with a two-times more risk of stroke and five-times more risk of cardiovascular mortality.
This condition increases the risk of heart failure by 140%. Untreated sleep apnea also can cause sleepiness during the day, poor concentration and increases the risk of high blood pressure and type two diabetes.
The growing recognition of sleep apnea’s health implications underscores the demand for accessible and effective treatments, particularly for patients unable to tolerate continuous positive airway pressure machines.
“Sleep apnea affects a significant number of people in Europe, but so does its treatment,” says Nicolas Di Prata, an investment officer from the European Investment Bank who worked on the loan to Nyxoah. “The airway pressure mask impacts a person’s comfort at night, their social life, and their partner, often leading to discontinuation of use. For people who struggle with it, that’s where Nyxoah offers a solution.”
A mask-free solution
The Genio device is designed to be minimally invasive. It’s implanted under the chin, roughly two centimetres deep, in a brief outpatient procedure. It operates without an external battery or visible parts, allowing for comfortable and discreet use.
“By offering a durable, reliable alternative to existing treatments, we aim to lower the healthcare burden associated with obstructive sleep apnea,” says Taelman. “Our focus on neurostimulation reduces the need for frequent hospital visits and mitigates the ongoing operational costs of managing chronic conditions.”
Nyxoah’s Taelman explains how it works.
“The most important muscle of the tongue is called the genioglossus muscle and its nerve is called hypoglossal,” he says. “Genio stimulates this nerve on both the left and right side, just under the chin, triggering the contraction of the posterior portion of the tongue, which will be gently pushed forward.”
By stimulating this nerve, the system keeps the tongue from collapsing back into the throat, ensuring that the airway remains open throughout the night.
Unlike invasive external devices, the neuro stimulator remains completely passive, until it’s needed.
“Genio is an entirely different way of working compared to the traditional masks,” says Ginger Smith, a project officer from the European Investment Bank who worked on the project. “The mask forces air into the airways, keeping the airways open. But with hypoglossal nerve stimulation, we’re stimulating a nerve that keeps things open. So, it’s a very different feeling.”
Distributing to sleep clinics and doctors
Nyxoah plans to commercialise its product through strategic partnerships and medical providers who specialise in sleep apnea and related treatments. Currently, its focus is on the European market, where it is already commercialised in some countries, with plans to expand to the US, establishing distribution channels through sleep clinics, hospitals, and specialised medical practitioners who can implant the device and provide ongoing patient support.
“With the EIB’s support, we are scaling up our operations to ensure that we can effectively bring our innovative solution to the U.S. market while continuing to serve Europe’s expanding needs,” says Taelman. “This includes ramping up production to ensure timely access for patients as we anticipate significant demand once regulatory approvals are finalised in the U.S.”
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