Nyxoah Announces 2024 Strategic Priorities
17 Janeiro 2024 - 6:05PM
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
data1 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 NyxoahNyxoah 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:NyxoahDavid DeMartino,
Chief Strategy Officerdavid.demartino@nyxoah.com +1 310 310
1313
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.
- ENGLISH_Nyxoah Announces 2024 Strategic Priorities
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