Nyxoah SA, a medical technology company focused on the development of solutions to treat obstructive sleep apnea (OSA), announced data from a real-world case series evaluating the treatment of three complete concentric collapse (CCC) patients with the Genio hypoglossal nerve stimulation system.
The investigator-sponsored case series was presented by Christian Plettenberg, MD, from the Universitätsklinikum Düsseldorf on Dec 8. Results showed an average apnea-hypopnea index (AHI) decrease of 73% and Epworth Sleepiness Scale 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%.
- Epworth Sleepiness Scale: The Epworth Sleepiness Scale 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 [hypoglossal nerve stimulation] eligible-to-treat OSA patients and are contraindicated to commercially available [hypoglossal nerve stimulation] therapy in the US. European [hypoglossal nerve stimulation] 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,” says Olivier Taelman, Nyxoah CEO, in a release.
Following the successful completion of the BLAST OSA study, the Genio system received its European CE Mark in 2019. Following the positive outcomes of the BETTER SLEEP study, Nyxoah received CE mark approval for the expansion of its therapeutic indications to CCC patients, currently contraindicated in competitors’ therapy.
Additionally, the company is currently conducting the DREAM IDE pivotal study for US Food and Drug Administration and US commercialization approval.
