Full Press Release Details
Provides Update on FDA Approvable Letter for Genio System
Expects to meet final FDA requirements for full
PMA approval in the second quarter
Mont-Saint-Guibert, Belgium - April
8, 2025, 7:00am CET / 1:00am ET - Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) ("Nyxoah" or the
"Company"), which develops breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA) through
neuromodulation, today announced an update on the FDA approval process for the Genio system.
On March 26, 2025, the Company announced that
the U.S. Food and Drug Administration (FDA) issued an Approvable Letter regarding the Company's Pre-Market Approval (PMA) application
for the Genio system.
The Approvable Letter means that Nyxoah's
application for marketing the device in the United States substantially meets the requirements of the Federal Food, Drug and Cosmetic
Act and the FDA's PMA implementing regulations codified at 21 C.F.R. Part 814, and the FDA will approve the application subject
to satisfactory completion of a manufacturing facilities, methods and controls review. FDA has accepted all other data provided with
the PMA submission, including most importantly the clinical study that demonstrates the safety and effectiveness of the Genio
Nyxoah is actively addressing one remaining item
before FDA approval may be granted which is the validation of one process used with a component of the Genio system at its U.S. manufacturing
site. The Company is confident that it will be able to successfully complete this validation in the near term. As such, Nyxoah anticipates
that its application could potentially be approved in the second quarter and intends to provide an update on the review process on its
first quarter 2025 earnings call to be held in May.
"We are pleased to share that the Approvable
Letter from FDA confirms that we are very close to PMA approval," commented Olivier Taelman, Nyxoah's Chief Executive Officer.
"We believe the final remaining step is completing a process validation at our U.S. manufacturing site - action taken in response
to the last set of specific validation questions sent by the FDA - which we are confident we can address swiftly and successfully.
We look forward to launching Genio in the U.S. upon receipt of FDA approval."
Nyxoah is a medical technology company focused
on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (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.
Following 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.
For more information, please visit http://www.nyxoah.com/.
Caution - CE marked since 2019. Investigational
device in the United States. Limited by U.S. federal law to investigational use in the United States
FORWARD-LOOKING STATEMENTS
Certain 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; receipt of FDA approval; satisfactory completion of a manufacturing facilities,
methods and controls review, and the anticipated timing of the foregoing; entrance to the U.S. market; 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, 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
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