• Compelling data published in prestigious journal show safety and efficacy of the Genio® system, a next-generation neurostimulation therapy for Obstructive Sleep Apnea (OSA)
• Results validate Genio® system as a novel, safe and effective treatment for OSA, a growing patient condition with 425 Million people suffering from moderate to severe OSA worldwide 1
• The Genio® system received CE Mark approval in March 2019 based on BLAST OSA clinical study results
Nyxoah S.A., a healthtech company focused on the development of innovative solutions and services for sleep related disorders, announced today the publication of data from the BLAST OSA (BiLAteral Hypoglossal Nerve Stimulation for Treatment of Obstructive Sleep Apnea) clinical study for the Genio® system in the European Respiratory Journal. These data demonstrate that treatment with the Genio® system was safe and effective, and resulted in significant improvement in patients’ Quality of Life measurements.
Key results from the BLAST OSA study include:
▪ A significant reduction in OSA severity: ▪ Apnea Hypopnea Index (AHI) decrease from 23.7 to 12.9 events/hr, a mean change of 10.8 events/hr (p<0.001)
▪ Oxygen Desaturation Index (ODI) decrease from 19.1 to 9.8 events/hr, a mean change of 9.3 events/hr (p<0.001)
▪ A significant improvement of daytime sleepiness (Epworth Sleepiness Scale (ESS), p=0.01) and sleep-related quality of life (Functional Outcomes of Sleep Questionnaire -10, p=0.02)
▪ The number of bed partners reporting loud, very intense snoring, or leaving the bedroom due to participant snoring decreased from 96% to 35%
▪ 91% of participants reported device use more than 5 days per week
The Genio® system is the world’s first and only battery-free, leadless and minimally invasive neurostimulator, capable of delivering bilateral hypoglossal nerve stimulation in moderate to severe Obstructive Sleep Apnea (OSA) patients who have not tolerated, have failed or refused Positive Airway Pressure (PAP) therapy.
Enrique Vega, Chief Executive Officer of Nyxoah,said: “The resultsfrom the BLAST OSA study published in ERJ demonstrate the potential of the Genio® system to become a nextgeneration, safe and efficient treatment option for patients in need of alternative solutions to PAP therapy.”
Robert Taub, Executive Chairman of Nyxoah, said: “OSA is a severe sleep disordered breathing condition that is associated with increased mortality risk and comorbidities, including cardiovascular diseases, depression and stroke. Nyxoah is currently focused on bringing this innovative technology to OSA patients in need of an alternative solution in Europe, Australia, New Zealand and the United States.”
About Obstructive Sleep Apnea (OSA) and the Genio® system
OSA is the world’s most common sleep disordered breathing condition, affecting almost one billion people globally1. It makes a person stop breathing during sleep, while the airway repeatedly becomes partially (hypopnea) or totally (apnea) blocked, limiting the amount of air that reaches the lungs. OSA is a chronic condition that is associated with increased mortality risk and comorbidities, including cardiovascular diseases, type 2 diabetes, obesity, depression and stroke. The current standard of care consists of Continuous Positive Airway Pressure (CPAP) therapy, a treatment whereby air is pushed into the upper airway to keep it open.
The Genio® system is the world’s first and only, battery-free, leadless and minimally invasive implanted neurostimulator designed to keep the upper airway open during sleep for certain people with OSA by bilateral stimulation of the hypoglossal nerve.
Nyxoah is a healthtech company focused on the development and commercialization of innovative solutions and services for sleep disordered breathing conditions. Nyxoah’s lead solution is the Genio® system, a validated, user-centered, next generation hypoglossal neurostimulation therapy for OSA, the world’s most common sleep disordered breathing condition that is associated with increased mortality risk2 and comorbidities including cardiovascular diseases, depression and stroke.
Following successful completion of the BLAST OSA study in patients with moderate to severe OSA, the Genio® system received its European CE Mark in March 2019. The Company is currently conducting the BETTER SLEEP study in Australia and New Zealand for therapy indication expansion, and a post-marketing EliSA study in Europe to confirm the long-term safety and efficacy of the Genio® system.
For more information, please visit www.nyxoah.com.
Caution – CE marked since 2019. Investigational device in the United States. Limited by United States federal law to investigational use.
1.Benjafield, Adam V et al. Estimation of the global prevalence and burden of obstructive sleep apnea: a literature-based analysis. Lancet Respir Med 2019 Published Online July 9, 2019 http://dx.doi.org/10.1016/S2213-2600(19)30198-5
2 Young T. et al: Sleep Disordered Breathing and Mortality: Eighteen-Year Follow-up of the Wisconsin Sleep Cohort, Sleep. 2008 Aug 1; 31(8): 1071–1078.