Nyxoah מספקת עדכון על אישור ה- FDA למערכת Genio
מצפה לעמוד בדרישות הסופיות של ה-FDA לאישור מלא של PMA ברבעון השני
מונט-סנט-גיברט, בלגיה, 8 באפריל 2025, (GLOBE NEWSWIRE) :
Nyxoah SA (נאסד"ק/יורונקסט בריסל: NYXH) ("Nyxoah" או "החברה"), חברת טכנולוגיות רפואיות שמתמקדת בפיתוח ומסחור של פתרונות ושירותים חדשניים לדום נשימה בשינה (OSA) באמצעות נוירומודולציה, הודיעה היום כי מינהל המזון והתרופות האמריקני (FDA) הודיעה היום על עדכון תהליך אישור ה-FDA למערכת Genio.
Nyxoah Provides Update on FDA Approvable Letter for Genio System
Expects to meet final FDA requirements for full PMA approval in the second quarter
Mont-Saint-Guibert, Belgium – April 8, 2025, 07:00am CET / 1:00am ET –
Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), which develops breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA) through neuromodulation, today announced an update on the FDA approval process for the Genio system.
On March 26, 2025, the Company announced that the U.S. Food and Drug Administration (FDA) issued an Approvable Letter regarding the Company's Pre-Market Approval (PMA) application for the Genio® system.
The Approvable Letter means that Nyxoah’s application for marketing the device in the United States substantially meets the requirements of the Federal Food, Drug and Cosmetic Act and the FDA’s PMA implementing regulations codified at 21 C.F.R. Part 814, and the FDA will approve the application subject to satisfactory completion of a manufacturing facilities, methods and controls review. FDA has accepted all other data provided with the PMA submission, including most importantly the clinical study that demonstrates the safety and effectiveness of the Genio® system.
Nyxoah is actively addressing one remaining item before FDA approval may be granted which is the validation of one process used with a component of the Genio system at its U.S. manufacturing site. The Company is confident that it will be able to successfully complete this validation in the near term. As such, Nyxoah anticipates that its application could potentially be approved in the second quarter and intends to provide an update on the review process on its first quarter 2025 earnings call to be held in May.
“We are pleased to share that the Approvable Letter from FDA confirms that we are very close to PMA approval,” commented Olivier Taelman, Nyxoah’s Chief Executive Officer. “We believe the final remaining step is completing a process validation at our U.S. manufacturing site – action taken in response to the last set of specific validation questions sent by the FDA – which we are confident we can address swiftly and successfully. We look forward to launching Genio in the U.S. upon receipt of FDA approval.”
About Nyxoah
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. Nyxoah completed two successful IPOs: on Euronext Brussels in September 2020 and NASDAQ in July 2021. 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 announced positive outcomes from the DREAM IDE pivotal study.
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
Contacts:
Nyxoah John Landry, CFO [email protected]
For Media In United States FINN Partners – Alyssa Paldo [email protected]
In International/Germany MC Services – Anne Hennecke [email protected]
In Belgium/France Backstage Communication – Gunther De Backer [email protected]
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