Nyxoah, a clinical-stage medical device company located in Mont-Saint-Guibert (Belgium), is gaining worldwide recognition as it won the Frost & Sullivan New Product Innovation Leadership Award (2014) as well as the World Technology Award (2014) for neurostimulation implant that treats Obstructive Sleep Apnea (OSA).

 

 

Fabian Suarez, Chief Financial Officer at Nyxoah tells us more about the ambition of the company.

These two awards clearly give us international recognition towards key stakeholders. They demonstrate that Nyxoah offers a cutting-edge technological innovation which establishes our credibility and fosters our positioning on the global market.

What is Obstructive Sleep Apnea?

FS – OSA is the result of a malfunctioning physiological condition. In normal people the muscles at the back of the neck (the pharyngeal muscles) relax and the pharynx gradually collapses. As the body exhales CO2, this acts as a driver to contract the pharyngeal muscles and keep the airway open. The difference with OSA sufferers is that the pharyngeal muscles do not contract – so the airway is blocked. Left untreated, OSA can have serious and cumulative negative effects.

What kind of effect does it have on patients?

FS – Daytime sleepiness and reduced cognitive function increase the risk of motor vehicle accidents. The condition can lead to memory loss, depression and a lower quality of life. Moreover, the persistent lack of oxygen during sleep can lead to high blood pressure, pulmonary hypertension, cardiac arrhythmia, congestive heart failure, heart disease and strokes. OSA can also be fatal.

How many people suffer from OSA?

FS – In OECD countries, 100 million people suffer from this condition, of whom 70 million suffer from moderate to severe OSA. Among these 70 million people, only 10 million are diagnosed. This number is increasing year after year. If OSA has been ignored for a long time, doctors now pay great attention with the emergence of potential causal links between OSA factors and obesity, cardiovascular diseases and strokes.

What are the treatments available and what is your solution?

FS – Today, there is one main solution to treat OSA: the Continuous Positive Airway Pressure (CPAP), a system combining a mask and a machine. Nevertheless, compliance with CPAP is still a huge challenge with more than 70 % of patients who stop using it within two years because it is not user-friendly and very constraining. Neurostimulation is now establishing its place as the best alternative to CPAP. Three companies in this field including Nyxoah are focusing on neurostimulation medical implants. Our competitors have developed technologies that are based on the pacemaker model, also referred to as IPG (implantable pulse generator). We have developed another solution with a tiny implant, wirelessly powered by a small adhesive patch and an activation chip, which is more affordable and less invasive for the patients.

You offer a therapeutic solution but do you plan to investigate diagnostic features?

FS – We are actually using a proprietary diagnostic component which allow us to predict OSA events before obstruction occurs and to stimulate the tongue before airflow is compromised. Nyxoah also plans to include its diagnostic technology in a home screening/diagnostic kit for identifying tongue-based OSA patients who might benefit from our system. Lastly, Nyxoah’s system can provide live patient information, including compliance and efficacy of the treatment, stored in a limited-access secure cloud. Healthcare providers can ensure ongoing treatment, streamline reimbursement and alert the patient if necessary.

What are you development prospects?

FS – First of all, we want to obtain the CE mark in order to commercialize our product in Europe in late 2016/beginning 2017. Then, we aim at having the FDA’s approval by 2019/2020 to launch the product on the US market, which is the biggest OSA market in the world. We are also considering to target the Middle-East region as well as Australia. To support our future development, the board of directors will soon define our financing strategy.

Do you think your international awards will support your development abroad?

FS – These two awards clearly give us international recognition towards key stakeholders. They demonstrate that Nyxoah offers a cutting-edge technological innovation which establishes our credibility and fosters our positioning on the global market.

Key facts & figures

• Nyxoah was created in 2009 by Mr. Robert Taub and Dr. Adi Mashiach.
• Headquartered in Mont-Saint-Guibert, Belgium, with R&D facilities there and in Tel Aviv, Israel.
• 20 employees.
• The company is supported by the Walloon Region in Belgium and raised in total EUR 20 million in equity and reimbursable advances from the Region.
• Nyxoah patent portfolio includes over 38 patent families around the world, of which 20 are already granted by the United States Patents Office.

Contac

Fabian Suarez
Chief Financial Officer
Tel.: + 32 2 612 17 55
E: