Nyxoah Receives FDA IDE Approval to Initiate the ACCCESS Study of Genio® in Complete Concentric Collapse Patients
11 Juli 2022 - 8:00AM
Nyxoah Receives FDA IDE Approval to Initiate the ACCCESS Study of
Genio® in Complete Concentric Collapse Patients
REGULATED INFORMATIONINSIDE
INFORMATION
Nyxoah Receives FDA IDE Approval to
Initiate the ACCCESS Study of Genio® in Complete Concentric
Collapse Patients
First ACCCESS patient expected to be implanted in
Q4 2022
Mont-Saint-Guibert, Belgium – July 11,
2022, 8:00am CET / 2:00am 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 that the U.S. Food and Drug Administration (FDA)
has approved an Investigational Device Exemption (IDE) to enable
Nyxoah to initiate a clinical trial, called ACCCESS, to evaluate
the use of the Genio® system for the treatment of adult patients
with moderate-to-severe OSA and Complete Concentric Collapse (CCC)
of the soft palate. The FDA had previously granted Breakthrough
Device Designation to Genio® to treat CCC patients.
In the ACCCESS trial, Nyxoah will implant up to
106 patients with co-primary efficacy endpoints of Apnea-Hypopnea
Index (AHI) responder rate, per the Sher criteria, and Oxygen
Desaturation Index (ODI) responder rate, both assessed at 12 months
post-implant. The first patient is expected to be
implanted during the fourth quarter of 2022, in-line with prior
guidance.
“The ACCCESS IDE approval is an important first
step to unlocking an enormous patient population, as more than 30%
of OSA patients in the U.S. have CCC. Nyxoah is the only
hypoglossal nerve stimulation (HGNS) company with a positive CCC
clinical trial and CCC approval in Europe, and the ACCCESS study
further strengthens our leadership position in addressing the needs
of these patients,” commented Olivier Taelman, Nyxoah’s Chief
Executive Officer. “CCC patients who are refractory to CPAP are
left with no option other than major palate surgery to treat their
OSA. Our BETTER SLEEP trial, which enabled Nyxoah to secure a CCC
label expansion in Europe and FDA Breakthrough Device Designation,
demonstrated that Genio® can provide these patients with a
minimally invasive solution for their disorder. Nyxoah is already
the only HGNS company with European CCC approval, bilateral
stimulation and both 1.5T and 3.0T full-body MRI compatibility, and
the ACCCESS trial is further demonstrating Nyxoah’s mission of
offering HGNS solutions to all patients suffering from CCC. We are
seeing outstanding results in CCC patients treated with Genio® in
Europe and are excited to begin the ACCCESS study and make Genio®
available to as many patients as possible.”
“Patients with Complete Concentric Collapse at
the soft palate, who have failed CPAP, represent a significant
unmet need in the treatment of OSA since, currently, the only FDA
approved hypoglossal nerve stimulation therapy is contraindicated
for these patients,” commented Dr. Maria Suurna, Otolaryngologist
and Director of Sleep Surgery at the University of Miami Health.
“The ACCCESS study provides hope for these patients, and their
treating physicians, that there may soon be a minimally invasive
surgical solution to address their OSA. I, along with the entire
sleep community, applaud Nyxoah for developing Genio® with
bilateral hypoglossal nerve stimulation and for conducting the
ACCCESS trial to provide a treatment alternative for this
underserved population.”
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.
Contacts:NyxoahLoic Moreau, Chief
Financial Officercorporate@nyxoah.com+32 473 33 19 80
Jeremy Feffer, VP IR and Corporate
Communicationsjeremy.feffer@nyxoah.com+1 917 749 1494
- ENGLISH_ACCCESS IDE Approval PR _FINAL
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