"Nyxoah SA a medical technology company developing innovative 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) had issued an Approvable Letter regarding the Company's Premarket Approval (PMA) application for the Genio® System.
The Approvable Letter signifies that Nyxoah's application to market 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 CFR Section 814, and that the FDA will approve the application subject to satisfactory completion of a review of manufacturing facilities, methods, and controls. The FDA has accepted all other data submitted with the PMA application, including, most importantly, the clinical study demonstrating the safety and effectiveness of the Genio® System.
Nyxoah is actively working on one remaining item before FDA approval is potentially granted: validation of a process used with a component of the Genio system at its U.S. manufacturing site. The Company is confident it will be able to successfully complete this validation in the near term. As such, Nyxoah anticipates its application could be approved during the second quarter and plans to provide an update on the review process during its first quarter 2025 earnings conference call in May.
“We are pleased to announce that the FDA’s approvable letter confirms that we are very close to PMA approval,” commented Olivier Taelman, Chief Executive Officer of Nyxoah. “We believe the last remaining milestone is the completion of process validation at our U.S. manufacturing facility—a step taken in response to the latest round of specific validation questions sent by the FDA—which we are confident we can address quickly and successfully. We look forward to launching Genio in the U.S. as soon as we receive FDA approval.”
Nyxoah operates in the medical technology sector. It focuses on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea Syndrome (OSAS). Nyxoah's lead solution is the Genio® System, a CE-marked, patient-centric, lead-free, battery-free hypoglossal nerve stimulation therapy for the treatment of Obstructive Sleep Apnea Syndrome (OSAS), the most common sleep-disordered breathing syndrome worldwide. OSAS is associated with an increased risk of mortality and comorbidities, including cardiovascular disease. Nyxoah's vision is that patients suffering from OSAS should be able to enjoy restful nights of sleep and live life to the fullest.
Following the successful completion of the BLAST OSA study, the Genio® System received the European CE Mark in 2019. Nyxoah successfully completed two IPOs: one on Euronext Brussels in September 2020 and the other on NASDAQ in July 2021. With the positive results of the BETTER SLEEP study, Nyxoah received the CE Mark for the extension of its therapeutic indications to patients suffering from complete concentric collapse (CCC), for whom competing therapies are currently contraindicated. In addition, the Company announced positive results from the pivotal DREAM IDE study.
For more information, visit www.nyxoah.com
Caution – CE Marked since 2019. Research Device in the United States. Restricted to investigational use in the United States by U.S. federal law.
Certain statements, beliefs and opinions contained in this press release are forward-looking in nature and reflect the current expectations of the Company or, as applicable, the directors or management of the Company regarding the Genio® System, the planned and ongoing clinical studies of the Genio® System, the potential benefits of the Genio® System, Nyxoah's objectives regarding the development, regulatory pathway and potential use of the Genio® System, receipt of FDA approval, satisfactory completion of the review of manufacturing facilities, methods and controls, and the anticipated timing of the foregoing, entry into the U.S. market, as well as the Company's results of operations, financial condition, liquidity, performance, prospects, growth and strategies. By their nature, forward-looking statements involve a number of risks, uncertainties, assumptions and other factors that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties, assumptions and factors could adversely affect the results and financial effects of the plans and events described herein. In addition, these risks and uncertainties include, but are not limited to, the risks and uncertainties set forth in the “Risk Factors” section of the Company’s Annual Report on Form 20-F for the year ended December 31, 2024, filed with the Securities and Exchange Commission (“SEC”) on March 20, 2025, and subsequent reports the Company files with the SEC. A multitude of factors, including, but not limited to, changes in demand, competition and technology, may cause actual events, performance or results to differ materially from any anticipated development. Forward-looking statements in this press release regarding past trends or activities are not guarantees of future performance and should not be relied upon as a representation that such trends or activities will continue in the future. Furthermore, even if actual results or developments are consistent with the forward-looking statements contained in this press release, such results or developments may not be indicative of results or developments in future periods. No representation or warranty is given as to the accuracy or correctness of such forward-looking statements. Accordingly,The Company expressly disclaims any obligation or undertaking to release updates or revisions to the forward-looking statements contained in this press release as a result of a change in expectations or a change in events, conditions, assumptions or circumstances on which these forward-looking statements are based, except as expressly required by law or regulation. Neither the Company, its advisors or representatives, nor any of its subsidiaries, nor the officers or employees of such persons guarantee that the assumptions underlying these forward-looking statements are free from errors and accept no responsibility for the future accuracy of the forward-looking statements contained in this press release or for the actual occurrence of the anticipated developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.
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