Nyxoah Submits Fourth and Final Module in PMA Application for Genio to the US FDA
01 7월 2024 - 3:00PM
Nyxoah Submits Fourth and Final Module in
PMA Application for Genio to the US FDA
Mont-Saint-Guibert
(Belgium), July 1,
2024, 8:00am CET / 2:00am
ET – (“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 that the Company submitted the
fourth and final module of its Premarket Approval (PMA) application
for Genio to the U.S. Food and Drug Administration (FDA).
Genio is a different approach to hypoglossal
nerve stimulation (HGNS). Genio offers patients a leadless,
fully-body MRI compatible, non-implanted battery solution, powered
and controlled by a wearable. Thanks to the fully upgradable
wearable component, Genio patients can always have access to the
most advanced technology without needing another surgery. In March
2024, Nyxoah announced the DREAM U.S. pivotal study data achieved a
statistically significant reduction in the co-primary endpoints of
12-month AHI responder rate, per the Sher criteria, and ODI
responder rate, both on an intent-to-treat basis, and that Genio is
the only HGNS solution to show similar outcomes in supine and
non-supine sleep.“I am proud to achieve this important milestone,
which brings us one step closer to offering Genio to obstructive
sleep apnea patients in the U.S. I would like to congratulate our
entire team on their hard work in completing the PMA submission. I
could not be more excited for the remainder of 2024, which includes
presenting the complete DREAM data at the International Surgical
Sleep Society meeting in September and preparing for a U.S. launch
by the end of the year,” commented Olivier Taelman, Nyxoah’s Chief
Executive Officer.
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 US
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; 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, 2023, filed with the
Securities and Exchange Commission (“SEC”) on March 20, 2024, 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.
Contact:
NyxoahDavid DeMartino, Chief
Strategy OfficerIR@nyxoah.com
For
MediaBelgium/FranceBackstage Communication – Gunther De
Backergunther@backstagecom.be
International/GermanyMC Services – Anne
Henneckeanne.hennecke@mc-services.eu
- ENGLISH_Nyxoah Submits Final Module in PMA
Application_FINAL
Nyxoah (EU:NYXH)
과거 데이터 주식 차트
부터 10월(10) 2024 으로 11월(11) 2024
Nyxoah (EU:NYXH)
과거 데이터 주식 차트
부터 11월(11) 2023 으로 11월(11) 2024
