By Bertrand Beauté

Nyxoah is spearheading European sleep tech, living 2021 on American time. In January, Nyxoah's Genio system designed to treat obstructive sleep apnoea was implanted in an American patient for the first time as part of the DREAM clinical study. This step should pave the company’s way into the American market. In February, Nyxoah signed an exclusive licence agreement with Vanderbilt University (Tennessee) to harness its neurostimulation technology. Then in July, the Belgian starlet debuted on the Nasdaq, the leading market for technology stocks. Nyxoah raised $97.8 million, much more than the $85.1 million the company had initially projected. Amid all these important events for the company, Olivier Taelman, Nyxoah’s CEO, took the time to answer questions from Swissquote Magazine.

Why is Obstructive Sleep Apnoea (OSA) a public health problem?

In people with OSA, the muscles in the pharynx relax too much, causing the upper airway to close partially or completely during sleep. This leads to repeated, involuntary respiratory arrest that impairs the patient’s sleep and quality of life. The brain lacks oxygen during these asphyxiation episodes, forcing the heart to pump more blood. In the short term, this leads to snoring, chronic fatigue and discomfort. In the longer term, OSA damages the brain and heart. Patients double their risk of stroke and have five times greater chances of developing cardiovascular disease. Treating OSA can therefore really make a difference for public health.

How widespread is the disorder?

Worldwide, more than 900 million people aged 30 to 69 suffer from OSA. But not all of them need to be treated. People who have less than 15 apnoeas per night have a mild form, which does not require medical attention. However, patients who develop moderate (15 to 30 respiratory arrests per night) and severe (more than 30) forms should get treatment. That comes out to 400 million people, but only 20% of them are actually being treated.

Why such a low percentage?

To be diagnosed, patients must go to a specialised centre where they spend the night, and their sleep is monitored. But not everyone has access to these facilities, which are also often overcrowded (ed. note: in Switzerland it can often take over six months to get an appointment). Therefore patients mainly go to see their general practitioner. Their doctor notes several symptoms, such as snoring, chronic fatigue and high blood pressure. But they don’t necessarily make the connection with obstructive sleep apnoea. They treat the symptoms rather than the cause. They prescribe a change in bed position to limit snoring, a healthier lifestyle, or even medication to lower blood pressure. But all that does not solve the cause of the problem. Only 15% of patients are correctly diagnosed. This generates a huge additional cost for health systems, due to the unnecessary tests and treatments prescribed during this period of medical limbo.

"Only 15% of patients are correctly diagnosed"

Tech companies sell connected objects, such as smartwatches, that track people’s sleep. Some manufacturers claim that their products can detect sleep In January, Nyxoah’s Genio system designed to treat obstructive sleep apnoea was implanted in an American patient for the first time as part of the DREAM clinical study. This step should pave the company’s way into the American market. In February, Nyxoah signed an exclusive licence agreement with Vanderbilt apnoea. Could that help to fight the under-diagnosis of this condition?

Many companies are investing money in sleep, because it’s a huge market. The problem is that very few consumer products have been scientifically proven to diagnose sleep apnoea. Most have not been clinically studied at all. Medicine is based on facts, not assumptions or marketing slogans.

Today, the best way to diagnose sleep apnoea is to go to a sleep centre and undergo a polysomnographic recording (PSG). Having said that, I think it’s very positive that tech companies are interested in sleep. They’ll bring a lot of innovation to the market.

Currently, the most effective treatment for sleep apnoea is CPAP (Continuous Positive Airway Pressure) therapy. What is the point of developing a new therapy like Nyxoah’s if CPAP machines are effective enough?

CPAP therapy requires patients to wear a mask all night. The mask delivers pressurised air into the patient’s mouth or nose to keep the upper airway open and thus limit the number of apnoea events. The treatment works very well but is not easy for patients. Wearing a mask hooked up to a machine via a tube is unpleasant and limits movement in bed. Plus, it impacts their partners. As a result, 50% of patients who use CPAP machines end up stopping their treatment. That means we need to find alternative solutions for them.

"Our device operates as simply as a smartphone"

We have therefore developed a system, Genio, which stimulates the hypoglossal nerve. Basically, it’s a tiny implant surgically placed under the patient’s chin. During an apnoea event, the device stimulates the hypoglossal nerve, which controls the tongue, thus keeping the upper airway open during sleep. Clinical studies have shown the effectiveness of our system, which received the European CE Mark in 2019. Genio is already on the market and covered by health systems in Germany, Switzerland and Spain. Other countries – such as Belgium, France, the United Kingdom and the Netherlands – are expected to follow. In the United States, we have just launched a clinical study that we expect to complete by the end of 2022. We plan for market launch in mid-2023.

You are entering the market at a time when the US company Inspire Medical, the world leader in this type of device, has been selling nerve stimulators to treat sleep apnoea for several years...

We have great respect for Inspire Medical. But they’re number one worldwide because they were the only ones in this segment. Today, we come to the market with ambition. We believe that we are capable of challenging them and becoming a world leader in the treatment of OSA. Our system has several advantages over theirs, especially because it is less invasive. Our treatment requires only one incision to implant it in the patient’s neck, as opposed to three (at the hip, ribs and neck) for the Inspire system. And the effectiveness of the devices is similar. In addition, all of Genio’s software and the battery remain outside the patient. That means we don’t need to re-operate to update the software or recharge the battery. In this respect, our device operates as simply as a smartphone. Its easy implantation and use are our main advantages over the competition.

And in terms of cost for health insurance companies?

Genio is priced similarly to the Inspire device, i.e. about €20,000 for the implant plus the cost of the operation. That is more expensive than CPAP machines, but the cost is the same after five years of using implants or CPAPs. Genio is designed to work for 10 years, so it is less expensive for patients than CPAP machines over its entire life cycle.

You’ve just signed an exclusive licensing agreement with Vanderbilt University in the United States to use their neurostimulation technology. How is it different from yours?

Hypoglossal nerve stimulation, whether with Inspire’s mechanism or ours, works in 70% of apnoea patients. But for the remaining 30%, it doesn’t work. However, Vanderbilt University has developed a technology that stimulates another nerve, the ansa cervicalis. And the initial tests are very encouraging. The agreement will allow us to use this technology to develop a new implant for patients who do not respond to current neurostimulation. It opens new horizons for us and strengthens our development pipeline.

Even though Nyxoah was already listed on Euronext Brussels, you chose to launch an IPO on the Nasdaq in July. What is the advantage of being listed on both markets?

There is more liquidity on the Nasdaq and by going public we wanted to attract American institutional investors. The funds raised (€85 million) during our IPO on Euro next Brussels in September 2020 should carry us through to the commercialisation of Genio on the US market, which is scheduled for mid-2023. The $97.8 million raised on the Nasdaq in July will cover our development thereafter.

THE NEUROSTIMULATION EXPERT

Born in Sint-Truiden in Flemish-speaking Belgium in 1971, Olivier Taelman was hired as head of Nyxoah in November 2019. He has vast experience in pharmaceuticals and medtech with an MBA from the Wharton School (University of Pennsylvania). Taelman began his career at Eli Lilly in 1996. After working for at Sanofi, he moved on to Minneapolis-based Medtronic from 2004 to 2013, where he expanded his knowledge of neurostimulation devices.

Nyxoah’s IPOs on Euronext Brussels in September 2020 and on the Nasdaq in July 2021 were not firsts for Taelman. In 2014, while heading the European operations for Nevro, a California-based startup specialised in spinal cord neuromodulation, he helped lead the company’s IPO on the Nasdaq. Today, Nevro’s capitalisation is $3.6 billion! And with Nyxoah, Taelman intends to repeat that success on the stock exchange.