Genio for healthcare professionals
The Genio system is the world’s first and unique battery-free, leadless, 1.5T and 3T full-body MRI compatible and single incision neurostimulator for patients who suffer from moderate to severe Obstructive Sleep Apnea (OSA). By dissociating the neurostimulator from its power unit and thanks to the unique bilateral nerve stimulation, the Genio sleep apnea treatment will shift the current paradigm in OSA therapy.
Patient outcomes
With the help of Genio hundreds of patients improved their lives
%
of patients reported using Genio more than 5 days/week
%
decrease of bed partners reporting loud or very intense snoring
%
of patients are satisfied with the Genio system
BLAST OSA Study
The BLAST OSA study data, published in the European Respiratory Journal, provide compelling safety and efficacy data of the Genio system, demonstrating that treatment with the Genio system resulted in a significant improvement in sleep apnea symptoms and patients' quality of life.
Safe therapy
The results from the BLAST OSA study demonstrated that the Genio system is well tolerated with no device-related serious adverse events.
Effective therapy
The BLAST OSA study demonstrated a 45.6% reduction in AHI (p<0.001) and a decrease in the oxygen desaturation index ODI by 48.7% (p<0.001), which is in line with other Hypoglossal Nerve Stimulation (HGNS) technologies reported performance at the same time stamp.
High therapy compliance
BLAST OSA data reported high therapy compliance, with 91% of participants using the system more than five nights per week and 77% of patients reporting a nightly use of more than 5 hours per night at 6 months.
Quality of life improvement
Results from the BLAST OSA study demonstrated that patients' quality of life significantly improved as assessed using the FOSQ-10 questionnaire, with an increase in score by 1.9 units (p=0.0157) and a decrease in the daytime sleepiness (ESS score) by 3.0 units (p=0.0113).
Snoring decreased
In addition, bed partners reporting loud, very intense snoring, or leaving the bedroom due to partner snoring decreased from 96% at baseline to 35% at 6 months post-implantation.
Clinical Research Program
Nyxoah is conducting several studies in Australia, New Zealand, Europe and USA, which are showing promising results so far.
EliSA Study
Multicenter, prospective single arm Post-Market Clinical Follow-up (PMCF) study of the Genio system in Europe for the treatment of Obstructive Sleep Apnea in adult moderate to severe OSA patients. At least 110 patients will be enrolled
Primary objective: Confirm the long-term safety and clinical effectiveness of the Genio system over a period of 5 years post-surgery.
BETTER SLEEP Study
Multicenter, prospective, open-label, 2 groups study, 42 patients enrolled
Objective: Collect clinical evidence on a sub-group of patients exhibiting a Complete Concentric Collapse (CCC) at the soft palate level, that will serve as an indication
DREAM Study
IDE pivotal study to receive FDA approval for the Genio system
Surgical implantation procedure
The implantation procedure is performed by a trained and certified surgeon. The procedure requires only one incision, takes about one hour to complete and is done under general anesthesia. The Implantable Stimulator constitutes the only implanted component of the Genio system. The device is placed over the genioglossus muscle, close to the tongue’s hypoglossal nerve.
Genio reinvents sleep
Genio is the world’s first and unique battery-free, leadless and single incision neurostimulator that was designed and developed with the user in mind.
Indications
Genio is indicated for moderate to severe OSA patients (AHI of 15 to 65) who are not significantly overweight, and who cannot tolerate, have failed or refused Positive Airway Pressure (PAP) therapy.
Surgeon Certification Process
To get started with Genio you need to follow a certain certification process:
1. Assessment
Qualification: ENT, Maxillo-Facial, Neurosurgeon
2. Initial Surgeon Training
Module 1: Self pre-training reading materials
Module 2: Genio system and implantation procedure
Module 3: Hands-on implant procedure on cadaver
Evaluation of cadaver implantation by the trainer > Initial certification
3. First Implantation
Requirement to line-up 2 patients for the first implantation
Implantations proctored by an experienced implanter
1. Assessment
Qualification: ENT, Maxillo-Facial, Neurosurgeon
2. Initial Surgeon Training
Module 1: Self pre-training reading materials
Module 2: Genio system and implantation procedure
Module 3: Hands-on implant procedure on cadaver
Evaluation of cadaver implantation by the trainer > Initial certification
3. First Implantation
Requirement to line-up 2 patients for the first implantation
Implantations proctored by an experienced implanter
1. Assessment
Qualification: ENT, Maxillo-Facial, Neurosurgeon
2. Initial Surgeon Training
Module 1: Self pre-training reading materials
Module 2: Genio system and implantation procedure
Module 3: Hands-on implant procedure on cadaver
Evaluation of cadaver implantation by the trainer > Initial certification
3. First Implantation
Requirement to line-up 2 patients for the first implantation
Implantations proctored by an experienced implanter
