Full Press Release Details
REGULATED INFORMATION
FDA Issues Nyxoah an Approvable Letter for
Belgium - March 26, 2025, 8:00am CET / 3:00am ET - Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) ("Nyxoah"
or the "Company"), that develops breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA) through neuromodulation,
today announced that the U.S. Food and Drug Administration (FDA) has 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. The Company will work
closely with the FDA to address these requests and is committed to bringing this innovative therapy to U.S. patients.
"The FDA has reviewed our submission
and determined that it substantially meets the requirements for approval: the FDA's Approvable Letter included no further questions
on the clinical data or biocompatibility that support the submission," commented Olivier Taelman, Nyxoah's Chief
Executive Officer. "We are still on the right track to make Genio available to U.S. patients suffering from OSA."
This decision does not impact Genio's CE Mark
or ongoing commercial activities in Europe, where the device is approved for both Complete Concentric Collapse (CCC) and non-CCC patients.
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.
more information, please visit http://www.nyxoah.com/.
- 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
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 utility of clinical data in potentially obtaining FDA approval of the Genio
system; the satisfactory completion of a manufacturing facilities, methods and controls review and receipt of FDA approval; 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 this press release.
Partners - Alyssa Paldo
In International/Germany
MC Services - Anne Hennecke
Backstage Communication - Gunther De Backer