{"id":829812,"date":"2025-03-26T03:03:12","date_gmt":"2025-03-26T07:03:12","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/fda-issues-nyxoah-an-approvable-letter-for-its-genio-system\/"},"modified":"2025-03-26T03:03:12","modified_gmt":"2025-03-26T07:03:12","slug":"fda-issues-nyxoah-an-approvable-letter-for-its-genio-system","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/fda-issues-nyxoah-an-approvable-letter-for-its-genio-system\/","title":{"rendered":"FDA Issues Nyxoah an Approvable Letter for its Genio\u00ae System"},"content":{"rendered":"
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\n INSIDE INFORMATION<\/b>
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\n REGULATED INFORMATION<\/b>\n <\/p>\n

\n FDA Issues Nyxoah an Approvable Letter for its Genio\u00ae System<\/b>\n <\/p>\n

\n Mont-Saint-Guibert, Belgium \u2013 March 26, 2025, 8:00am CET \/ 3:00am ET \u2013 Nyxoah SA (Euronext Brussels\/Nasdaq: NYXH)<\/b> (\u201cNyxoah\u201d or the \u201cCompany\u201d), that develops breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA) through neuromodulation, today announced that the U.S. Food and Drug Administration (FDA) has issued an Approvable Letter regarding the Company’s Pre-Market Approval (PMA) application for the Genio\u00ae system.<\/p>\n

The Approvable Letter means that Nyxoah\u2019s application for marketing the device in the United States substantially meets the requirements of the Federal Food, Drug and Cosmetic Act and the FDA\u2019s 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. The Company will work closely with the FDA to address these requests and is committed to bringing this innovative therapy to U.S. patients.<\/p>\n

\u201cThe FDA has reviewed our submission and determined that it substantially meets the requirements for approval: the FDA\u2019s Approvable Letter included no further questions on the clinical data or biocompatibility that support the submission,\u201d commented Olivier Taelman, Nyxoah\u2019s Chief Executive Officer. \u201cWe are still on the right track to make Genio available to U.S. patients suffering from OSA.\u201d<\/p>\n

This decision does not impact Genio’s CE Mark or ongoing commercial activities in Europe, where the device is approved for both Complete Concentric Collapse (CCC) and non-CCC patients.<\/p>\n

\n About Nyxoah<\/b>
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Nyxoah is a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA). Nyxoah\u2019s lead solution is the Genio\u00ae system, a patient-centered, leadless and battery-free hypoglossal neurostimulation therapy for OSA, the world\u2019s 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.\u00a0<\/p>\n

Following the successful completion of the BLAST OSA study, the Genio\u00ae 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\u2019 therapy. Additionally, the Company announced positive outcomes from the DREAM IDE pivotal study.<\/p>\n

For more information, please visit http:\/\/www.nyxoah.com\/<\/a>.<\/p>\n

\n Caution <\/b>\u2013 CE marked since 2019. Investigational device in the United States. Limited by U.S. federal law to investigational use in the United States.<\/p>\n

\n FORWARD-LOOKING STATEMENTS<\/b>\n <\/p>\n

Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company\u2019s or, as appropriate, the Company directors\u2019 or managements\u2019 current expectations regarding\u00a0 the Genio\u00ae system; planned and ongoing clinical studies of the Genio\u00ae system; the potential advantages of the Genio\u00ae system; Nyxoah\u2019s goals with respect to the development, regulatory pathway and potential use of the Genio\u00ae system; the utility of clinical data in potentially obtaining FDA approval of the Genio\u00ae system; the satisfactory completion of a manufacturing facilities, methods and controls review and receipt of FDA approval; entrance to the U.S. market; and 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 outcome and financial effects of the plans and events described herein. Additionally, these risks and uncertainties include, but are not limited to, the risks and uncertainties set forth in the \u201cRisk Factors\u201d section of the Company\u2019s Annual Report on Form 20-F for the year ended December 31, 2024, filed with the Securities and Exchange Commission (\u201cSEC\u201d) on March 20, 2025, and subsequent reports that the Company files with the SEC. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities are not guarantees of future performance and should not be taken as a representation that such trends or activities will continue in the future. In addition, even if actual results or developments are consistent with the forward-looking statements contained in this press release, those results or developments may not be indicative of results or developments in future periods. No representations and warranties are made as to the accuracy or fairness of such forward-looking statements. As a result, the Company expressly disclaims any obligation or undertaking to release any updates or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based, except if specifically required to do so by law or regulation. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person’s officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.<\/p>\n

\n Contacts:<\/b>\n <\/p>\n

\n Nyxoah<\/b>
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John Landry, CFO
IR@nyxoah.com<\/a><\/p>\n

\n For Media<\/b>
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In United States
FINN Partners \u2013 Alyssa Paldo
alyssa.paldo@finnpartners.com<\/a><\/p>\n

In International\/Germany
MC Services \u2013 Anne Hennecke
nyxoah@mc-services.eu<\/a><\/p>\n

In Belgium\/France
Backstage Communication \u2013 Gunther De Backer
gunther@backstagecom.be<\/a><\/p>\n

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\n Attachment<\/strong>\n <\/p>\n