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.

for professionals

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BLAST OSA study

BLAST OSA study

Surgical implantation procedure

Surgical implantation procedure

Experts’ corner

Experts’ corner

Certification process

Certification process

MRI Information

MRI Information

Patient outcomes

With the help of Genio hundreds of patients improved their lives

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of patients reported using Genio more than 5 days/week

sleep reduction apnea

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decrease of bed partners reporting loud or very intense snoring

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%

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.

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Safe therapy

The results from the BLAST OSA study demonstrated that the Genio system is well tolerated with no device-related serious adverse events.

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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.

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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.

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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).

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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.

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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.

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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

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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.

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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.

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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:

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1. Assessment

Qualification: ENT, Maxillo-Facial, Neurosurgeon

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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

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3. First Implantation

Requirement to line-up 2 patients for the first implantation
Implantations proctored by an experienced implanter

document

1. Assessment

Qualification: ENT, Maxillo-Facial, Neurosurgeon

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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

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3. First Implantation

Requirement to line-up 2 patients for the first implantation
Implantations proctored by an experienced implanter

document

1. Assessment

Qualification: ENT, Maxillo-Facial, Neurosurgeon

steto

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

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3. First Implantation

Requirement to line-up 2 patients for the first implantation
Implantations proctored by an experienced implanter

Experts' corner

Leading international Hypoglossal Nerve Stimulation experts share their perspective on OSA, the promising future of HGNS and the Genio system.

Dr. Richard Lewis

ENT Surgeon, Perth, Australia

Dr. Lewis is a true Genio pioneer, he has performed the first Genio implantation in the world, has done more than 25 implants and has proctored around 25 surgical procedures of the system worldwide. Watch his video for an excellent overview of the Genio system and to hear about the positive impact the therapy has on the quality of life of his patients.

Prof. Dr. Olivier Vanderveken, MD, PhD

Head of Dept. of Otorhinolaryngology Head and Neck surgery, Antwerp University Hospital (UZA), Belgium

Watch the video interview of Prof. Vanderveken to learn more about the history and position of UZA as a center of excellence for the treatment of Obstructive Sleep Apnea(OSA) in Belgium and the potential of hypoglossal nerve stimulation to become a first-line therapy for OSA patients in the future.

Prof. Dr. med. Clemens Heiser

Head of the Sleep Laboratory at Klinikum rechts der Isar, Technical University of Munich, Germany

Watch the video to find out what Prof. Heiser thinks is in store for the future of hypoglossal nerve stimulation and his experience with Nyxoah’s Genio therapy.

Prof. Stuart MacKay

ENT surgeon and OSA expert, Illawarra ENT Head & Neck Clinic, Australia

Prof. Mackay explaining the Genio system bilateral hypoglossal nerve stimulation and the patient titration and programming. The video also includes the experience of Dr Jennifer Walsh, Centre for Sleep Science, at the University of Western Australia that has the greatest number of patients that are currently using the Genio therapy in Australia.

genio hotline
genio hotline
Please contact us by telephone (without obligation and free of charge) from Monday to Friday between 9:00 a.m. and 6:00 p.m. or as follows: