Nyxoah Announces 2024 Strategic Priorities
Mont-Saint-Guibert, Belgium - January 17, 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, in
anticipation of upcoming investor meetings, its strategic priorities for 2024.
2024 Strategic Priorities
* Complete patient follow up in the DREAM U.S. pivotal study and report
efficacy and safety data by early April. 12-month efficacy data(1) on the
first 34 DREAM patients and safety data on all DREAM patients were presented
at SLEEP 2023, demonstrating a 65% AHI responder rate, a 76% ODI responder
rate and safety in-line with expectations. These data are preliminary and
not conclusive of final DREAM success.
* File the fourth and final module in the modular PMA submission. Anticipate
submitting the final module shortly after announcing DREAM results.
* Accelerate investments in the U.S. commercial organization in preparation
for a late 2024 launch. Recently hired Francis Kim as Chief Regulatory and
Quality Officer and expanded market access to secure reimbursement at
launch.
* Complete enrollment in the ACCCESS complete concentric collapse (CCC) U.S.
pivotal study. Recently announced investigator-sponsored data in Europe
demonstrating Genio's® success in treating CCC patients.
* Increase hypoglossal nerve stimulation (HGNS) market penetration and Genio
market share in Europe. For 2024, we expect continued sales growth driven by
an increasing benefit from direct-to-consumer (DTC) initiatives, initial
contribution from the ResMed commercial partnership in Germany and
geographic expansion.
"Since Nyxoah's founding we have been guided by the mission to improve the lives
of OSA patients. This led to the development of the patient-centric Genio HGNS
system. Genio's single-incision, leadless, upgradable design powered and
controlled by a wearable resonated with clinicians and patients and led to a
strong European launch. Genio's bilateral stimulation enables treatment of CCC,
and the label was subsequently expanded to include these patients, whose only
treatment option after failing CPAP up until then was major palate surgery,"
commented Olivier Taelman, Chief Executive Officer.
"In our ongoing effort to provide patients greater control over their therapy,
thereby making sleep simple again, we then received approval for Genio 2.1.
Genio 2.1 offers patients daily feedback on therapy usage and autonomy to adjust
stimulation amplitude within pre-defined boundaries, improving patient comfort
and compliance without the need for a surgical procedure to replace the
implantable component."
"We are now on the cusp of the most significant milestone in the Company's
history with the reporting of DREAM results in the coming months. We expect to
complete the PMA submission shortly after and are accelerating manufacturing and
commercial investments to ensure we are fully prepared to replicate our European
success in the U.S. With an approaching U.S. launch and continued growth in
Europe, we are excited for the coming years."
About Nyxoah
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 approval.
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.
Contacts:
Nyxoah
David DeMartino, Chief Strategy Officer
david.demartino@nyxoah.com (mailto:David.demartino@nyxoah.com)
+1 310 310 1313
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(1) For the trial to be successful, of the 115 patients, at least 63% of
patients need to be AHI and ODI responders at the 12-month follow-up.
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