FDA Approves Genio® 2.1 For Use in DREAM U.S. IDE Pivotal Study
01 Juni 2022 - 10:30PM
FDA Approves Genio® 2.1 For Use in DREAM U.S. IDE Pivotal Study
FDA Approves Genio® 2.1 For Use in DREAM U.S.
IDE Pivotal Study
New smartphone application, upgraded activation
chip, improved user interface, and stimulation amplitude trimming
enhance patient experience and comfort
Mont-Saint-Guibert, Belgium – June 1, 2022,
10:30pm CET / 4:30pm 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 the
use of Nyxoah's next generation Genio® 2.1 system for use in the
Company’s DREAM U.S. IDE pivotal study. Genio® 2.1’s upgrades are
entirely related to the external components of the Genio® system,
as the implantable stimulator remains unchanged.
Genio® 2.1 further demonstrates Nyxoah’s
patient-centric approach to addressing the needs of those suffering
from moderate-to-severe OSA. The system features updates to
the Genio® activation chip and a new smartphone application to
enable daily reporting of therapy usage, which will support therapy
acclimation and long-term compliance. Additional features of Genio®
2.1 include an improved user interface and the ability for
clinicians to make more incremental stimulation adjustments. This
is particularly meaningful for patients who are more sensitive to
neurostimulation, as with Genio® 2.1 physicians can fine-tune
stimulation amplitude to determine the optimal level of comfort for
patients without compromising therapy efficacy.
“Genio® 2.1’s features, along with existing
full-body 3.0T MRI compatibility, illustrate Nyxoah’s patient-first
mission in OSA product development,” commented Olivier Taelman,
Nyxoah’s Chief Executive Officer. “The updated activation chip and
new smartphone app, combined with our upgraded user interface and
increased stimulation resolution, represent key next steps in
optimizing patient outcomes. We are excited to make these important
new features available to patients in our DREAM trial.”
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_Genio 2.1 Approval PR_FINAL
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