DREAM Pivotal Study Data Presented at the
International Surgical Sleep Society 2024 Educational
Update
Additional clinical data on patients suffering
from Obstructive Sleep Apnea (OSA) demonstrate a clinically
significant 71.0% median reduction in Apnea-Hypopnea index (AHI)
while sleeping supineat 12 months compared with baseline.
82.0% of patients who completed a polysomnography
at 12 months had an AHI below 15, and 67.4% of patients who
completed a polysomnography at 12 months had an AHI below 10.
Mont-Saint-Guibert, Belgium – September
27, 2024, 10:30pm CET / 4:30pm ET – Nyxoah SA (Euronext
Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), a
medical technology company that develops breakthrough treatment
alternatives for Obstructive Sleep Apnea (OSA) through
neuromodulation, announced that data from the DREAM U.S. pivotal
study were presented in an oral session at the International
Surgical Sleep Society (ISSS) 2024 Educational Update, taking place
from September 26 -27 in Miami, Florida.
Additional data were presented for AHI reduction
in supine and non-supine positions. Genio bilateral stimulation
resulted in a clinically meaningful 71.0% median reduction in
supine AHI at 12 months compared with baseline. This reduction
compares to a median 12-month AHI reduction of 70.8% across all
sleeping positions.
With respect to secondary endpoints reported at
ISSS, subjects demonstrated significant improvements in
quality-of-life outcomes. Specifically, a mean increase of 2.3
points was observed in the Functional Outcomes of Sleep
Questionnaire (FOSQ) assessment. Additionally, the Epworth
Sleepiness Score was reduced by a mean of 3.4 points from
baseline.
The presentation included previously announced
data demonstrating that the study achieved its co-primary endpoints
of 12-month AHI responder rate, per the Sher criteria, and Oxygen
Desaturation Index (ODI) responder rate, both on an Intent-To-Treat
(ITT) basis. In the DREAM U.S. pivotal study, 115 patients received
the Genio® implant and were included in the safety analysis. These
patients had a mean AHI of 28.0, mean ODI of 27.0 and mean body
mass index of 28.5 at baseline. At 12 months, 73 subjects were
determined to be AHI responders, per the Sher criteria*, resulting
in an ITT AHI responder rate of 63.5% (p=0.002), and 82 subjects
were determined to be ODI responders, resulting in an ODI responder
rate of 71.3% (p<0.001). Safety results were in line with other
neuromodulation therapies, with 11 serious adverse events, or SAEs,
in ten subjects resulting in an SAE rate of 8.7%. Out of the 11
SAEs, three were device related, and there were three explants.
“The DREAM study demonstrated efficacy of
bilateral hypoglossal nerve stimulation using Genio for the
treatment of obstructive sleep apnea. Clinically significant
improvements in primary and secondary endpoints were observed,”
said B. Tucker Woodson, MD, Chief, Professor – Medical College of
Wisconsin and Principal Investigator of the DREAM study. “Genio has
the potential of helping us advance neuromodulation therapy for the
treatment of OSA.”
“Achieving meaningful AHI reductions regardless
of sleep position is a clinical validation of our patient-centric
approach,” said Olivier Taelman, CEO of Nyxoah. “Genio bilateral
stimulation also enabled more than 80% of patients to hit 12 months
with an AHI below 15, positively impacting their overall quality of
life and reducing sleepiness. Nyxoah is now entering the final
regulatory phase and is progressing toward FDA approval. This will
be a huge milestone in our mission to make Genio available to OSA
patients in the US.”
About Nyxoah
Nyxoah is reinventing sleep for the billion
people that suffer from obstructive sleep apnea (OSA). We are a
medical technology company that develops breakthrough treatment
alternatives for OSA through neuromodulation. Our first innovation
is Genio®, a battery-free hypoglossal neuromodulation device that
is inserted through a single incision under the chin and controlled
by a wearable. Through our commitment to innovation and clinical
evidence, we have shown best-in-class outcomes for reducing OSA
burden.
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 for
FDA and U.S. commercialization approval.
For more information, please see the Company’s annual report for
the financial year 2023 and 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 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 U.S. pivotal
trial; filing for FDA approval; and entrance to the U.S. market. 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.
Contacts:
NyxoahLoïc Moreau, Chief
Financial OfficerIR@nyxoah.com
For MediaIn United StatesFINN
Partners – Glenn Silverglenn.silver@finnpartners.com
In Belgium/FranceBackstage Communication –
Gunther De Backergunther@backstagecom.be
In International/GermanyMC Services – Anne
Henneckenyxoah@mc-services.eu
- ENGLISH_DREAM Data Presentation at ISSS Congress_FINAL
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