Full Press Release Details
Provides Update on Expanded Middle East Presence
Centers in Dubai, Kuwait, and Abu Dhabi Following First Genio Implant in the Region Earlier in 2025
Belgium - September 23, 2025, 10:10pm CET / 4:10pm ET - Nyxoah SA (Euronext Brussels/Nasdaq: NYXH), a medical technology
company that develops breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA), today announced the continued expansion
of its commercial footprint in the Middle East, following the first successful Genio implant in Abu Dhabi in September 2025.
Middle East is home to world-class healthcare systems, renowned Key Opinion Leaders, and centers of excellence with outstanding facilities.
Nyxoah is proud to partner with these institutions spread over Dubai, Kuwait, and Abu Dhabi to broaden access to Genio and improve outcomes
for patients living with Obstructive Sleep Apnea who are unable to tolerate CPAP.
Taelman, Chief Executive Officer of Nyxoah, commented: "The Middle East represents an important and growing market for Nyxoah, and
we are delighted to see this momentum since our initial launch in the region earlier this year. Expanding from Dubai into Kuwait and
Abu Dhabi allows us to bring the unique, patient-centric Genio solution to more individuals suffering from Obstructive Sleep Apnea. We
are grateful to collaborate with leading healthcare institutions and experts in the region, who share our mission to transform the treatment
of OSA and make sleep simple for patients worldwide."
its growing network of centers across the Middle East, Nyxoah continues to deliver on its commitment to expand patient access to Genio,
the only leadless, externally powered bilateral hypoglossal nerve stimulation system for the treatment of moderate-to-severe OSA.
is a medical technology company focused on the development and commercialization of innovative solutions to treat OSA. Nyxoah's
lead solution is the Genio system, a patient-centered, leadless and battery-free hypoglossal neurostimulation therapy for OSA, the world's
most common sleep disordered breathing condition that is associated with increased mortality risk and cardiovascular comorbidities. Nyxoah
is driven by the vision that OSA patients should enjoy restful nights and feel enabled to live their life to its fullest.
the successful completion of the BLAST OSA study, the Genio system received its European CE Mark in 2019. Nyxoah completed two successful
IPOs: on Euronext Brussels in September 2020 and NASDAQ in July 2021. Following the positive outcomes of the BETTER SLEEP study, Nyxoah
received CE mark approval for the expansion of its therapeutic indications to Complete Concentric Collapse (CCC) patients, currently
contraindicated in competitors' therapy. Additionally, the Company announced positive outcomes from the DREAM IDE pivotal study
and U.S. FDA approval of a Premarket Approval application.
more information, please visit http://www.nyxoah.com/.
- CE marked since 2019. FDA approved in August 2025 as prescription-only device.
statements, beliefs and opinions in this press release are forward-looking, which reflect the Company's or, as appropriate, the
Company directors' or managements' current expectations regarding the Genio system; planned and ongoing clinical studies
of the Genio system; the potential advantages of the Genio system; Nyxoah's goals with respect to the development, regulatory pathway
and potential use of the Genio system; the Company's commercialization strategy and entrance to the U.S. and Middle East markets; the
Company's intellectual property portfolio; and the Company's results of operations, financial condition, liquidity, performance,
prospects, growth and strategies. By their nature, forward-looking statements involve a number of risks, uncertainties, assumptions and
other factors that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements.
These risks, uncertainties, assumptions and factors could adversely affect the outcome and financial effects of the plans and events
described herein. Additionally, these risks and uncertainties include, but are not limited to, the risks and uncertainties set forth
in the "Risk Factors" section of the Company's Annual Report on Form 20-F for the year ended December 31, 2024, filed
with the Securities and Exchange Commission ("SEC") on March 20, 2025, and subsequent reports that the Company files with
the SEC. A multitude of factors including, but not limited to, changes in demand, competition and technology, or adverse litigation outcomes
can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements
contained in this press release regarding past trends or activities are not guarantees of future performance and should not be taken
as a representation that such trends or activities will continue in the future. In addition, even if actual results or developments are
consistent with the forward-looking statements contained in this press release, those results or developments may not be indicative of
results or developments in future periods. No representations and warranties are made as to the accuracy or fairness of such forward-looking
statements. As a result, the Company expressly disclaims any obligation or undertaking to release any updates or revisions to any forward-looking
statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances
on which these forward-looking statements are based, except if specifically required to do so by law or regulation. Neither the Company
nor its advisers or representatives nor any of its subsidiary undertakings or any such person's officers or employees guarantees that
the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future
accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You
should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.