The Genio system offers bilateral stimulation of the hypoglossal nerve branches, which may lead to potentially greater airway opening for patients with obstructive sleep apnea.
The FDA has approved a magnetic resonance imaging (MRI) conditional labeling for Nyxoah’s Genio neurostimulation-based obstructive sleep apnea (OSA) therapy, currently being evaluated in the DREAM pivotal investigational device exemption (IDE) study.1
The revised labeling ensures patients who have already implanted the Genio system and those set to receive the therapy can now undergo full-body 1.5T and 3T MRI diagnostic scans within approved parameters, along with accessing the benefits that the unique bilateral stimulation therapy brings.
"The approval by the [FDA], received only a week after similar CE mark approval in Europe, confirms again the unique and unparalleled design of our technology. With the prevalence of MRI scans in the United States being one of the highest in the world, we are delighted that Nyxoah will be able to fulfil the currently unmet need for full-body 1.5T and 3T MR conditional labeling,” Olivier Taelman, chief executive officer, Nyxoah, said in a statement.
Nyxoah received IDE approval from the FDA in June 2020 for the DREAM (Dual-sided Hypoglossal neRvE stimulAtion for the treatMent of Obstructive Sleep Apnea) study, which aims to confirm the safety and effectiveness of the Genio system in 134 moderate to severe patients with OSA who failed first line continuous positive airway pressure (CPAP) therapy.2
The Genio system is the world’s first and unique battery-free, leadless neurostimulator that stimulates the hypoglossal nerve bilaterally while maintaining upper airway during sleep, allowing patients to enjoy the night without be obstructed.3 Through a minimally invasive surgical procedure, the neurostimulator is implanted under a patient’s chin, as well as over the genioglossus muscle, close to the tongue’s hypoglossal nerve. The stimulator’s electrodes are placed in contact with both branches of the hypoglossal nerve resulting in bilateral stimulation of the nerve, which then triggers a slight forward movement of the posterior portion of the tongue.
It is paired with an external Activation Chip, which allows the process of stimulation and forward movement towards helping maintain an open airway. Patients who utilize the Genio system connect the Activation Chip to the Disposable Patch placed under the chin as part of bedtime routine. After use, the Activation Chip can be detached from the Disposable Patch and the used patch can be disposed.
In November 2019, Nyxoah announced data demonstrating the benefits and safety of the Genio system. The case study report featured a healthy, 60-year-old woman with moderate OSA, and found the surgical implantation of the stimulator to be well-tolerated with an uneventful recovery.4
The polysomnography (PSG) at 6 months showed that apnea hypopnea index (AHI) per hour, obstructive apnea events per hour, hypopnea events per hour, and oxygen desaturation index were reduced by 88%, 92%, 88%, and 97%, respectively, while nadir O2 saturation improved to 91%.
Taelman added, “Such an extensive labeling is unique to Nyxoah in the field of neurostimulation-based OSA therapies. Currently other therapies cannot fully address this need due to limitations to 1.5T MRI scans and body areas exclusion.”
This news follows another FDA action this month for an OSA-related indication, after the agency authorized marketing of a new prescription for Signifier Medical Technologies’ eXciteOSA device intended to reduce snoring and mild OSA in adult patients who are aged 18 years or older, according to a recent announcement.5