Mont-Saint-Guibert (Belgium) and Utrecht (The Netherlands) – Nyxoah S.A. (“Nyxoah” or the “Company”) a health-technology company focused on the development and commercialization of innovative solutions and services to treat sleep disordered breathing conditions, today announces its intention to raise new funds through an Initial Public Offering (“IPO”) with admission of all of its shares on the regulated market of Euronext Brussels (the “Offering”). Current shareholders have already expressed their commitment to subscribe for an aggregate amount of no less than €15 million in the Offering to the Nyxoah IPO.
- Nyxoah is developing and commercializing the Genio® system, a CE-Mark validated, user-centered, bilateral neurostimulation therapy to treat moderate to severe Obstructive Sleep Apnea (OSA), the world’s most common sleep disordered breathing condition that is associated with increased mortality risk and comorbidities including cardiovascular diseases, depression and strokes.
- Compared to other hypoglossal nerve stimulation (HGNS) technologies for the treatment of OSA, the Genio® system is the world’s first and only battery-free, minimally invasive and leadless neurostimulator implant.
- Focused on the large and fast-growing world OSA market with 936 million people between 30 and 69 years of age suffering from OSA globally. There are 425 million moderate-to-severe OSA patients for whom treatment would be required.
- Yearly eligible population to Hypoglossal Nerve Stimulation in the U.S. and Europe/ANZ combined is estimated to be 1.1 million new patients, representing a USD 20 billion opportunity.
- The Genio® system is intended to be used as a second-line therapy to treat moderate-to-severe OSA patients who have failed conventional therapy, including Continuous Positive Airway Pressure (“CPAP”).
- Nyxoah has currently obtained reimbursement in Germany under the existing NUB (Neue Untersuchungs- und Behandlungsmethoden) system for HGNS, generating its first revenue and is further preparing commercial market entrance in focused European countries.
- Nyxoah has recently obtained approval by the FDA (Food and Drug Administration) to initiate its DREAM IDE (Investigational Device Exemption) pivotal trial. First U.S. patient enrolments are expected to take place in 2020.
- The BLAST OSA clinical study which was published in the European Respiratory Journal, a leading clinical journal, provided first positive results on safety and efficacy on the Genio® System.
- Long-term clinical data (five years) are being gathered through the ongoing EliSA trial, spread over approximately 25 sleep centers across Europe.
- The ongoing BETTER SLEEP study is designed to build clinical evidence for a potential additional therapy indication for contraindicated complete concentric collapse (“CCC”) patients, who represent approximately 25% of moderate to severe OSA patients.
- Led by a strong and experienced team with a proven track record in the Health Industry and bringing companies to market.
- Backed by high-quality investors combining historical shareholders under the lead of Mr. Robert Taub and other serial entrepreneurs as well as strategic investors Cochlear Limited (ASX: COH) and ResMed Inc. (NYSE: RMD, ASX: RMD), Gilde Healthcare and SRIW, the Regional Investment Company of Wallonia.
About Obstructive Sleep Apnea
OSA is the world’s most common sleep disordered breathing condition. It makes a person stop breathing during sleep, while the airway repeatedly becomes partially (hypopnea) or totally (apnea) blocked, limiting the amount of air that reaches the lungs. OSA is a chronic condition that is associated with increased mortality risk and comorbidities, including cardiovascular diseases, diabetes, obesity, depression and stroke. The current standard of care consists of Continuous Positive Airway Pressure (CPAP) therapy, a treatment whereby air is pushed into the upper airway to keep it open.
Key advantages of the Genio® System
The Company believes that the Genio® system has the potential to have an improved therapeutic effect compared to other existing hypoglossal nerve stimulation therapies and other second-line OSA therapies, thanks to the following key benefits:
- Safe and effective therapy: results from the BLAST OSA study demonstrated that the Genio® system is well tolerated, with no device-related serious adverse events being reported and effective with a statistically significant reduction in AHI (Apnea Hypopnea Index) and ODI (Oxygen Desaturation Index) after six months compared to no treatment.
- High therapy compliance: BLAST OSA data reported high therapy compliance, with 91% of participants using the system more than five nights per week over a period of six months.
- Quality of life improvement: results from the BLAST OSA study demonstrated that patients’ quality of life significantly improved.
- Specifically designed for OSA: in contrast to other hypoglossal nerve stimulation technologies, the Genio® system has been specifically designed to treat OSA.
- Minimally invasive: the Genio® system only has one implantable part, which is leadless and battery-free, and which requires only one incision allowing for a quick and easy implantation procedure.
- Bilateral hypoglossal nerve stimulation: As clinical research suggests, Nyxoah believes that bilateral stimulation results in a stronger muscle contraction, a more symmetric tongue movement, and a wider opening of the airway as compared to unilateral stimulation whereby only one branch of the hypoglossal nerve is stimulated.
- Partially external device, without implanted battery: the activation chip, including the user’s personalized therapy program and the device’s battery, is an external device, which will facilitate future updates and upgrades of the Genio® system or battery replacements, without the need for additional surgery.
- To demonstrate an improvement in net health outcomes for the sleep community, long-term clinical data (five years) are being gathered through the Company’s ongoing EliSA trial, spread over approximately 25 sleep centers across Europe.
For further information, please contact:
Rémi Renard, VP Therapy Development and Education
+32 472 12 64 40
For media enquiries, please contact:
Consilium Strategic Communications
Amber Fennell, Ashley Tapp, Lindsey Neville, Taiana De Ruyck Soares
+44 (0)20 3709 5700
Nyxoah is a healthtech company focused on the development and commercialization of innovative solutions and services for sleep disordered breathing conditions. Nyxoah’s lead solution is the Genio® system, a CE-Mark validated, user-centered, next generation hypoglossal neurostimulation therapy for OSA, the world’s most common sleep disordered breathing condition that is associated with increased mortality risk and comorbidities including cardiovascular diseases, depression and stroke.
Following successful completion of the BLAST OSA study in patients with moderate to severe OSA, the Genio® system received its European CE Mark in March 2019. The Company is currently conducting the BETTER SLEEP study in Australia and New Zealand for therapy indication expansion, and a post-marketing EliSA study in Europe to confirm the long-term safety and efficacy of the Genio® system. In June 2020, the FDA has approved Nyxoah’s Investigational Device Exemption (IDE) application allowing Nyxoah to commence the pivotal DREAM study to support FDA approval in the U.S. For more information, please visit the company’s website at www.nyxoah.com.
About Gilde Healthcare
Gilde Healthcare is a specialized healthcare investor managing over €1.4 billion ($1.5 billion) across two fund strategies: venture & growth capital and private equity. Gilde Healthcare’s venture & growth capital fund invests in fast growing companies active in digital health, medtech and therapeutics. The venture & growth companies are based in Europe and North America. Gilde Healthcare’s private equity fund invests in profitable European lower mid-market healthcare companies with a focus on the Benelux and DACH region. The private equity fund targets healthcare providers, suppliers of medical products and service providers in the healthcare market. For more information, visit the company’s website at www.gildehealthcare.com.
Caution – CE marked since 2019. Investigational device in the United States. Limited by federal law to investigational use.