Francis Kim appointed as Chief Regulatory and Quality Officer
Mont-Saint-Guibert, Belgium – November 28, 2023, 10:30pm CET / 4:30pm ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA), today announced the appointment of Francis Kim as Chief Regulatory and Quality Officer. Francis will be leading Nyxoah’s Global Regulatory and Quality departments.
Francis is a highly experienced global regulatory and quality executive in the healthcare industry, having spent more than 25 years in the medical device and life sciences sector. Francis has led Regulatory and Quality departments at Medtronic, Philips, and other companies, including introducing several innovative products and therapies to the market.
“Nyxoah is entering the most exciting time in the Company’s history, with data from the DREAM U.S. pivotal study in early 2024, followed by submission of the final module in our modular PMA and FDA approval expected by the end of the year. I am excited having someone with Francis’ regulatory and quality experience joining Nyxoah at this important time, and I look forward to continued investments as we prepare to for a U.S. market entrance,” commented Olivier Taelman, Nyxoah Chief Executive Officer.
Nyxoah is a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA). Nyxoah’s lead solution is the Genio® system, a patient-centered, leadless and battery-free hypoglossal neurostimulation therapy for OSA, the world’s most common sleep disordered breathing condition that is associated with increased mortality risk and cardiovascular comorbidities. Nyxoah is driven by the vision that OSA patients should enjoy restful nights and feel enabled to live their life to its fullest.
Following the successful completion of the BLAST OSA study, the Genio® system received its European CE Mark in 2019. Following the positive outcomes of the BETTER SLEEP study, Nyxoah received CE mark approval for the expansion of its therapeutic indications to Complete Concentric Collapse (CCC) patients, currently contraindicated in competitors’ therapy. Additionally, the Company is currently conducting the DREAM IDE pivotal study for FDA and U.S. commercialization approval.
For more information, please visit http://www.nyxoah.com/.
Caution – CE marked since 2019. Investigational device in the United States. Limited by U.S. federal law to investigational use in the United States.
David DeMartino, Chief Strategy Officer
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