Skip to main content

Nyxoah announces full-body 1.5T and 3T MRI compatibility for the Genio® system to treat Obstructive Sleep Apnea (OSA)

Written by Customer Service on . Posted in Public Companies.

A picture containing clock, light, drawing Description automatically generatedPRESS RELEASENyxoah announces full-body 1.5T and 3T MRI compatibility for the Genio® system to treat Obstructive Sleep Apnea (OSA)Mont-Saint-Guibert, Belgium – 26th January, 2021 – Nyxoah SA (Euronext: NYXH) (“Nyxoah” or the “Company”), a health-technology company focused on the development and commercialization of innovative solutions and services to treat Obstructive Sleep Apnea (OSA), today announces the Company has received CE Mark Magnetic Resonance Imaging (MRI) conditional labeling for the current Genio® neurostimulation-based OSA therapy to treat Obstructive Sleep Apnea.This revised labeling ensures that patients who receive the Genio® system and those already implanted can now undergo full-body 1.5T and 3T MRI diagnostic scans within approved parameters and access the benefits of Genio® unique bilateral stimulation therapy.Olivier Taelman, Chief Executive Officer of Nyxoah, commented: “We are delighted to announce full-body 1.5T and 3T MR conditional CE mark approval for the Genio® system, resulting from the unique and unparalleled design of our technology. Such an extensive labeling is unique to Nyxoah in the field of neurostimulation-based OSA therapies. Currently other therapies cannot fully  address this need due to limitations to 1.5T MRI scans and body areas exclusion. As a company, Nyxoah always puts the patient first and seeks to ensure minimal disruption of their daily life and optimal Quality of Life (QOL).”Prof. Dr. Clemens Heiser, MD, MHBA, PhD, ENT surgeon from Klinikum Rechts der Isar – Munich added: “Prevalence of MRI scans as diagnostic modality is growing, especially for OSA patients, as this condition is being associated with increased risk of comorbidities, such as cardiovascular diseases. The addition of 1.5T and 3T full-body MR conditional labeling for the Genio® system will be another critical benefit for my patients and will help me ensure those who may need an MRI can benefit from Nyxoah’s innovations with no fear for themselves and their implant during the exam”.– ENDS –For further information, please contact:Nyxoah
Milena Venkova, Corporate Communications Manager
milena.venkova@nyxoah.com
+32 490 11 93 57
About NyxoahNyxoah is a healthtech company focused on the development and commercialization of innovative solutions and services to treat Obstructive Sleep Apnea (OSA). Nyxoah’s lead solution is the Genio® system, a CE-validated, patient-centered, next generation hypoglossal neurostimulation therapy for OSA, the world’s most common sleep disordered breathing condition that is associated with increased mortality risk1 and comorbidities including cardiovascular diseases, depression and stroke.
Following the successful completion of the BLAST OSA study in patients with moderate to severe OSA, the Genio® system received its European CE Mark in 2019. The Company is currently conducting the BETTER SLEEP study in Australia and New Zealand for therapy indication expansion, the DREAM IDE pivotal study for FDA approval 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 – Genio® is CE marked since 2019. Investigational device in the United States. Limited by U.S. federal law to investigational use in the United States.1 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.AttachmentPR – Genio MRI Compatible labeling

Disclaimer & Cookie Notice

Welcome to GOLDEA services for Professionals

Before you continue, please confirm the following:

Professional advisers only

I am a professional adviser and would like to visit the GOLDEA CAPITAL for Professionals website.

Important Notice for Investors:

The services and products offered by Goldalea Capital Ltd. are intended exclusively for professional market participants as defined by applicable laws and regulations. This typically includes institutional investors, qualified investors, and high-net-worth individuals who have sufficient knowledge, experience, resources, and independence to assess the risks of trading on their own.

No Investment Advice:

The information, analyses, and market data provided are for general information purposes only and do not constitute individual investment advice. They should not be construed as a basis for investment decisions and do not take into account the specific investment objectives, financial situation, or individual needs of any recipient.

High Risks:

Trading in financial instruments is associated with significant risks and may result in the complete loss of the invested capital. Goldalea Capital Ltd. accepts no liability for losses incurred as a result of the use of the information provided or the execution of transactions.

Sole Responsibility:

The decision to invest or not to invest is solely the responsibility of the investor. Investors should obtain comprehensive information about the risks involved before making any investment decision and, if necessary, seek independent advice.

No Guarantees:

Goldalea Capital Ltd. makes no warranties or representations as to the accuracy, completeness, or timeliness of the information provided. Markets are subject to constant change, and past performance is not a reliable indicator of future results.

Regional Restrictions:

The services offered by Goldalea Capital Ltd. may not be available to all persons or in all countries. It is the responsibility of the investor to ensure that they are authorized to use the services offered.

Please note: This disclaimer is for general information purposes only and does not replace individual legal or tax advice.