Nyxoah S.A., a medical device company focused on the development and commercialization of a best-in-class hypoglossal nerve stimulation (HGNS) therapy for the treatment of Obstructive Sleep Apnea (OSA), announced today that it successfully raised an additional €15 million ($17.1 million USD) in their most recent round of equity financing.
The financing was led by Cochlear Limited (www.cochlear.com), an Australian medical device company (ASX: COH) and global leader in implantable hearing solutions. Cochlear invested €13 million and the round was completed by several existing Nyxoah shareholders. A representative of Cochlear has joined the Nyxoah Board.
Robert Taub, Chairman of the Nyxoah Board said: “We are extremely pleased to welcome Cochlear as a new investor. Their board-level participation will accelerate Nyxoah’s vision of becoming a leader in OSA therapy.”
Jan Janssen, Chief Technology Officer of Cochlear said: “Cochlear actively monitors the market for novel technologies and implantable devices that over the long term may leverage its core business. Nyxoah’s minimally invasive solution presents an attractive alternative for patients with compliance or intolerance issues in respect of existing therapies. We look forward to working with Nyxoah.”
Nyxoah recently completed the BLAST-OSA (BiLAteral Hypoglossal Nerve Stimulation for Treatment of Obstructive Sleep Apnea) clinicalstudy, an essential milestone for its CE marking dossier already submitted to the European regulatory body.
“Patients from the BLAST OSA study show a major improvement in sleep apnea symptoms including a significant reduction of ODI (Oxygen Desaturation Index) and AHI (Apnea Hypopnea Index),” said Enrique Vega, Chief Executive Officer of Nyxoah S.A. “The Nyxoah therapy was also associated with high patient compliance and improvements in patient Quality of Life. We look forward to publishing the clinical results in a leading medical journal during 2019.” The additional financing will be used to initiate post-CE Mark European market development activities and to work toward Investigational Device Exemption (IDE) with the US Food and Drug Administration (FDA)
About Obstructive Sleep Apnea (OSA) and the Genio® system
OSA is the world’s most common sleep disordered breathing condition, affecting almost one billion people globally1. 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, type 2 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.
The Genio® system is the world’s first and only, battery-free, leadless and minimally invasive implanted neurostimulator designed to keep the upper airway open during sleep for certain people with OSA by bilateral stimulation of the hypoglossal nerve.
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 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 risk2 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.
For more information, please visit www.nyxoah.com.
Caution – CE marked since 2019. Investigational device in the United States. Limited by United States federal law to investigational use.
1.Benjafield, Adam V et al. Estimation of the global prevalence and burden of obstructive sleep apnea: a literature-based analysis. Lancet Respir Med 2019 Published Online July 9, 2019 http://dx.doi.org/10.1016/S2213-2600(19)30198-5
2 Young T. et al: Sleep Disordered Breathing and Mortality: Eighteen-Year Follow-up of the Wisconsin Sleep Cohort, Sleep. 2008 Aug 1; 31(8): 1071–1078.