Nyxoah publishes positive Obstructive Sleep Apnea data from BLAST OSA study in the European Respiratory Journal

BELGIUM


 

Nyxoah publishes positive Obstructive Sleep Apnea data from BLAST OSA study in the European Respiratory Journal

  • 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 worldwide1
  • The Genio® system received CE Mark approval in March 2019 based on BLAST OSA clinical study results

Mont-Saint-Guibert, Belgium – 28 October, 2019, 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 results from the BLAST OSA study published in ERJ demonstrate the potential of the Genio® system to become a next-generation, 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.”

– ENDS –

About Obstructive Sleep Apnea (OSA) and the Genio® system

OSA is the world’s most common sleep disorder, affecting almost 1 billion people globally.1 OSA 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 associated with increased mortality risk and comorbidities, including cardiovascular diseases, depression and stroke. The current standard of care consists of Positive Airway Pressure (PAP) therapy, a treatment whereby air is pushed into the upper airway via a mask connected to a pump. Despite its proven efficacy, there are many limitations to this therapeutic option meaning compliance is a serious challenge.

The Genio® system is the world’s first and only, battery-free, leadless and minimally invasive implanted neurostimulator that helps keep the upper airway open, allowing patients to breathe normally while sleeping. It offers a simple, convenient, safe and effective alternative to PAP, addressing the needs of patients seeking another treatment option.

About Nyxoah

Nyxoah is a healthtech company focused on the development of innovative, neurostimulation-based solutions and services for sleep related disorders. Nyxoah’s lead technology is the Genio® system, the world’s first and only, battery-free, leadless and minimally invasive implanted neurostimulator that treats the underlying cause of Obstructive Sleep Apnea (OSA), a market worth approximately $10bn in the US alone. The Genio® system received its European CE Mark in March 2019 and a US trial programme for FDA approval is in preparation.

For more information, please visit www.nyxoah.com.

Caution – CE marked since 2019. Investigational device in the USA. Limited by federal law to investigational use.




1 Benjafield, Adam V et al. Estimation of the global prevalence and burden of obstructive sleep apnoea: a literature-based analysis. Lancet Respir Med 2019 Published Online July 9, 2019 http://dx.doi.org/10.1016/S2213-2600(19)30198-5