Belgian medtech firm Nyxoah launches Genio neurostimulation therapy in England

Nyxoah SA, a Belgium-based medical technology company listed on Euronext Brussels and Nasdaq, has announced the commercial launch of its Genio system in England. This groundbreaking achievement is marked by the first successful patient implants at University College London Hospitals (UCLH), a globally recognised institution for healthcare excellence. The launch represents a significant step forward in the treatment of obstructive sleep apnea (OSA), a condition that affects millions of people worldwide.

First Patients Treated Under NHS Specialised Services

The Genio system is now available under the NHS Specialised Services Devices Programme (SSDP), a vital initiative aimed at increasing patient access to cutting-edge medical technologies. This inclusion allows patients at designated centres to benefit from advanced solutions like the Genio system, addressing a critical need for effective OSA treatment innovation.

At UCLH, the first two implants were performed by Ryan Chin Taw Cheong, Consultant ENT and Sleep Surgeon. Highlighting the importance of the therapy, Cheong explained that the Genio system introduces a neurostimulation therapy solution specifically designed for patients who have not responded well to traditional CPAP therapy alternatives. This approach provides a minimally invasive yet highly effective treatment for moderate to severe cases of obstructive sleep apnea.

What Sets Genio Apart

The Genio system offers a revolutionary approach to innovative sleep treatment, leveraging neuromodulation to treat obstructive sleep apnea. Unlike conventional therapies, Genio is a battery-free device implanted beneath the chin via a single incision, making it a convenient and less invasive option.

The system operates by stimulating the hypoglossal nerve, which prevents the tongue from blocking the airway during sleep. This forward movement of the tongue significantly reduces apnea episodes and improves breathing, offering a comfortable and user-friendly alternative to CPAP therapy alternatives. The external activation chip, placed under the chin with an adhesive patch, controls the device during sleep, ensuring seamless functionality and ease of use.

Clinical studies have repeatedly validated the effectiveness of the Genio system. Patients treated with this neurostimulation therapy solution have experienced reduced apnea severity, diminished snoring, and improved overall quality of life, making it an essential development in OSA treatment innovation.

Clinical and Regulatory Milestones

Nyxoah’s journey toward bringing the Genio system to market has been marked by significant milestones. Following the BLAST OSA study, the device secured European CE Mark approval in 2019. Further advancements included an expanded indication for Complete Concentric Collapse (CCC) patients, a group previously excluded from many competitor treatments.

The company’s DREAM IDE pivotal study demonstrated positive outcomes, laying the groundwork for FDA approval and the eventual launch of the Genio system in the United States. As a leader in OSA treatment innovation, Nyxoah has also strengthened its position in the market through successful IPOs on Euronext Brussels in 2020 and Nasdaq in 2021, reflecting confidence in its ability to redefine obstructive sleep apnea treatment.

CEO Highlights Vision for Expansion

Olivier Taelman, CEO of Nyxoah, called the commercial launch of the Genio system in England a momentous achievement. He praised the collaboration with University College London Hospitals and expressed excitement about expanding access to this innovative sleep treatment through partnerships with other NHS centres of excellence.

“This is a pivotal step in making Genio available to patients who need an alternative to traditional therapies. Our mission to provide simple, effective solutions for obstructive sleep apnea continues to drive our commitment to innovation and patient care,” he said.

A Promising Future for OSA Treatment in England

The introduction of the Genio system in England provides a game-changing opportunity for individuals who cannot tolerate conventional therapies like CPAP. By offering a minimally invasive, effective, and comfortable solution, Nyxoah aims to transform the landscape of obstructive sleep apnea management.

As collaborations with leading hospitals such as University College London Hospitals expand, the availability of this neurostimulation therapy solution will grow, improving patient outcomes and setting a new standard for OSA treatment innovation in England and beyond.