The US Food and Drug Administration (FDA) has approved the use of Nyxoah SA’s next generation Genio 2.1 system for use in the company’s DREAM United States investigational device exemption pivotal study. Genio is Nyxoah’s neurostimulator designed to treat moderate to severe obstructive sleep apnea (OSA). 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 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 adherence. 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,” says Olivier Taelman, Nyxoah CEO, in a release. “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.”