Nyxoah S.A Announces Implantation of First US Patient in DREAM Pivotal IDE Study

Feb, 2021 - by CMI

Nyxoah S.A., a Belgian-based medical device company, focused on R&D and commercialization of neurostimulation-based therapy for the treatment of Obstructive Sleep Apnea (OSA), achieved implantation of the first U.S patient in the DREAM pivotal IDE study. The DREAM (Dual-sided Hypoglossal neRvE stimulAtion for the treatMent of Obstructive Sleep Apnea) study will enroll 134 patients to assess the efficacy of Genio System for the treatment of OSA.

Anyone at any age could have OSA, but it is most common among middle-age and elderly adults. About 2 percent of young children have obstructive sleep apnea; however, it is also more common in elderly men than in women. According to the study, ‘Estimation of the global prevalence and burden of obstructive sleep apnea: a literature-based analysis’, published in July 2019, 936 million adults aged 30–69 years have mild to severe obstructive sleep apnea and 425 million adults aged 30–69 years have moderate to severe obstructive sleep apnea globally.

However, what is scary is the fact that as much as 90 percent of those with obstructive sleep apnea do not even know they have it and therefore untreated, it could result in serious health issues. As soon as any individual notices that he or she has sleep apnoea, he or she should seek medical advice to determine the cause and find out a proper treatment for it. The sooner a person gets treated for sleep apnea, the better his or her long-term prognosis will be.

There are various types of treatments for obstructive sleep apnea depending on the severity of the condition. One of the most recommended treatments is surgery. In most cases, when the upper airways are clogged by fat deposits, surgery is needed to remove these fatty layers in order for the airways to open up and properly breathe. Surgery is usually done as an outpatient procedure in order to reduce any possible complications. In some severe cases, permanent surgery may be required, but this should only be considered as a last resort after all other measures have been taken to correct the condition.

Nyxoah’s Genio System is an easy-to-use, comfortable and efficient sleep apnea treatment that provides users the freedom to enjoy a restful sleep and live their life to the fullest again. It received its European CE Mark in March 2019 following successful completion of the BLAST OSA study in patients with moderate to severe OSA.