Nyxoah Announces Real World Case Series Demonstrating Positive Results in Treating CCC Patients with Genio®
11 Dezember 2023 - 7:30AM
Nyxoah Announces Real World Case Series
Demonstrating Positive Results in Treating CCC Patients with
Genio®
Data presented at the DGSM Conference in Berlin
by Dr. Christian Plettenberg on December 8, 2023Results showed an
average AHI decrease of 73%
Mont-Saint-Guibert, Belgium – December
11, 2023, 7:30am CET / 1:30am 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 data from a real-world case
series evaluating treatment of three complete concentric collapse
(CCC) patients with the Genio® hypoglossal nerve stimulation
system. The investigator-sponsored case series was presented by
Dr. Christian Plettenberg from the Universitätsklinikum
Düsseldorf on December 8, 2023. Results showed an average
apnea-hypopnea index (AHI) decrease of 73% and Epworth Sleepiness
Scale (ESS) decrease of 58%. There were no implant related adverse
events.
Key Results:
-
AHI: The AHI in Patient 1 decreased from 44/h to
5.6/h, in Patient 2 from 24/h to 11.2/h and in Patient 3 from 36/h
to 11.2/h. This resulted in an average reduction of 73%.
-
ESS: The ESS in Patient 1 decreased from 15 to 2,
in Patient 2 from 12 to 9 and in Patient 3 from 11 to 5. This
resulted in an average reduction of 58%.
“These data further validate Genio’s bilateral
stimulation approach in treating CCC patients, who represent
approximately 30% of HGNS eligible-to-treat OSA patients and are
contraindicated to commercially available HGNS therapy in the US.
European HGNS market growth accelerated with our CE-Mark CCC label
expansion, and, pending FDA approval, I am excited to bring Genio
to CCC patients in the US,” commented Olivier Taelman, Nyxoah’s
Chief Executive Officer. “I want to thank Dr. Plettenberg and his
colleagues for their important work which reinforces Genio as a
treatment solution for both non-CCC and CCC patients.”
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.
Contact:NyxoahDavid DeMartino,
Chief Strategy Officerdavid.demartino@nyxoah.com +1 310 310
1313
- ENGLISH_Nyxoah Announces Real World Case Series Demonstrating
Positive Results in Treating CCC
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