Full Press Release Details
Preliminary Results for the Fourth Quarter and Full Year 2023
Belgium - January 9, 2024, 10:05pm CET / 4:05pm ET - Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) ("Nyxoah"
or the "Company"), a medical technology company focused on the development and commercialization of innovative solutions
to treat Obstructive Sleep Apnea (OSA), today announced certain preliminary, unaudited results for the fourth quarter and full year ended
Preliminary, Unaudited Fourth Quarter and Full
"We are excited with the strong preliminary
fourth quarter sales, which are anticipated to be nearly double from last quarter. This anticipated growth reflects both strong underlying
demand for Genio and focus on streamlining the patient referral pathway through initiatives such as our direct-to-consumer online campaigns
launched in March," commented Olivier Taelman, Chief Executive Officer. "This performance throughout 2023 sets the stage for
an exciting 2024, as in a few months we expect to report data from our DREAM US pivotal trial, file for FDA approval, begin preparations
to enter the US market, and begin to see contribution from the ResMed commercial partnership in Germany."
The preliminary, unaudited revenue
results described in this press release are estimates only and are subject to revision until Nyxoah reports its full financial results
for 2023 in its Annual Report on Form 20 F.
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 is currently conducting the DREAM IDE pivotal study for FDA and U.S. commercialization
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; the utility of clinical data in potentially obtaining FDA approval of the Genio
system; reporting data from Nyxoah's DREAM US pivotal trial; filing for FDA approval; entrance to the US market, contributions
from the ResMed commercial partnership in Germany; 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, 2022, filed
with the Securities and Exchange Commission ("SEC") on March 22, 2023, 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.
David DeMartino, Chief Strategy Officer