Nyxoah Announces Real World Case Series Demonstrating Positive Results in Treating CCC Patients with Genio®

Rhea-AI Summary

Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) announced positive results in treating complete concentric collapse (CCC) patients with the Genio® hypoglossal nerve stimulation system. Data presented at the DGSM Conference in Berlin by Dr. Christian Plettenberg on December 8, 2023, showed an average AHI decrease of 73%. The results demonstrated significant improvements in AHI and ESS, with no implant-related adverse events reported. The company's CEO, Olivier Taelman, expressed excitement about the potential FDA approval and the opportunity to bring Genio to CCC patients in the US.

Positive

• Positive results in treating CCC patients with the Genio® system
• Average AHI decrease of 73%
• No implant-related adverse events reported
• Potential for FDA approval and expansion to the US market

Negative

• None.

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, 2023
Results 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 Nyxoah
Nyxoah 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:
Nyxoah
David DeMartino, Chief Strategy Officer
david.demartino@nyxoah.com
+1 310 310 1313

Attachment

• ENGLISH_Nyxoah Announces Real World Case Series Demonstrating Positive Results in Treating CCC

FAQ

What did the data presented at the DGSM Conference show?

The data showed an average AHI decrease of 73% in treating CCC patients with the Genio® system.

Who presented the data at the conference?

Dr. Christian Plettenberg presented the data at the DGSM Conference.

What were the key results of the case series?

The AHI in patients decreased by an average of 73%, and the ESS decreased by an average of 58%.

What did the CEO, Olivier Taelman, express excitement about?

He expressed excitement about the potential FDA approval and the opportunity to bring Genio to CCC patients in the US.