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Revealed Sep 02, 2024 • 5 minute learn
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Nyxoah Rings the Closing Bell at Nasdaq whereas Making ready for U.S. Market Launch of Modern Sleep Apnea System
FDA regulatory submission for the Firm’s Genio® machine is full, U.S. approval on monitor for the tip of 2024
U.S. industrial launch, anticipated at the start of 2025, absolutely funded with over €85 million in new capital raised
Nyxoah – NASDAQ Closing Bell Ceremony 29 août 2024
Mont-Saint-Guibert, Belgium – September 2, 2024 10:05pm CET / 4:05PM ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Firm”), a medical expertise firm centered on the event and commercialization of progressive options to deal with Obstructive Sleep Apnea (OSA), rang the Nasdaq Closing Bell on August 29, 2024 to acknowledge the Firm’s latest progress and spotlight upcoming milestones on its path to the U.S. market launch of its progressive patient-centric Genio® hypoglossal nerve stimulation expertise for OSA, a prevalent and extreme sleep-related respiratory dysfunction related to elevated mortality threat and cardiovascular comorbidities.
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“We’re honored to ring the Closing Bell and to have a good time our latest medical and regulatory achievements within the U.S. We glance ahead with pleasure to the upcoming U.S. launch of our lead product, Genio,” commented Olivier Taelman, Nyxoah’s Chief Govt Officer. “The U.S. is the most important healthcare market globally and due to this fact of strategic significance for us. With sturdy medical proof from our pivotal DREAM examine, strong funding in place and our strengthened US industrial group, we really feel nicely positioned to enter the US market. We have now submitted the ultimate module of our PMA submission to the FDA and are on monitor for U.S. approval by the tip of 2024. If permitted, Genio might change into accessible within the U.S. as early as the start of 2025.”
Olivier Taelman, CEO of Nyxoah – NASDAQ Closing Bell Ceremony 29 august 2024
Current Highlights and Upcoming Milestones of Nyxoah’s U.S. Commercialization Technique
- Announcement of optimistic information from the pivotal U.S. examine, DREAM, concerning Nyxoah’s Genio® system, an progressive hypoglossal neurostimulation remedy for Obstructive Sleep Apnea (OSA) in spring 2024.
- Remaining module submitted within the modular PMA submission, initiating FDA interactive evaluate.
- Constructing a U.S. industrial group, headed by Scott Holstine as the brand new Chief Business Officer together with key gross sales, advertising and market entry leaders.
- The U.S. market launch of Genio® is absolutely funded following the profitable elevating of over €85 million in development capital via a €48.5 million fairness providing and a €37.5 million mortgage facility settlement with the European Funding Financial institution (EIB).
- FDA approval anticipated approval by US Meals and Drug Administration by the tip of 2024.
- U.S. market launch of Genio® deliberate for the start of 2025.
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To view the published of the Nasdaq Closing Bell ceremony, please go to: https://www.nasdaq.com/news-and-insights/nasdaq-stock-market-bell-ceremonies
About Nyxoah
Nyxoah is a medical expertise firm centered on the event and commercialization of progressive options to deal with Obstructive Sleep Apnea (OSA). Nyxoah’s lead resolution is the Genio® system, a patient-centered, leadless and battery-free hypoglossal neurostimulation remedy for OSA, the world’s most typical sleep disordered respiratory situation that’s related to elevated mortality threat and cardiovascular comorbidities. Nyxoah is pushed by the imaginative and prescient that OSA sufferers ought to get pleasure from restful nights and really feel enabled to stay their life to its fullest.
Following the profitable completion of the BLAST OSA examine, the Genio® system acquired its European CE Mark in 2019. Nyxoah accomplished two profitable IPOs: on Euronext Brussels in September 2020 and NASDAQ in July 2021. Following the optimistic outcomes of the BETTER SLEEP examine, Nyxoah acquired CE mark approval for the growth of its therapeutic indications to Full Concentric Collapse (CCC) sufferers, presently contraindicated in opponents’ remedy. Moreover, the Firm introduced optimistic outcomes from the DREAM IDE pivotal examine for FDA and U.S. commercialization approval.
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For extra data, please see the Firm’s annual report for the monetary 12 months 2023 and go to http://www.nyxoah.com/.
Warning – CE marked since 2019. Investigational machine in the US. Restricted by U.S. federal regulation to investigational use in the US.
Ahead-looking statements
Sure statements, beliefs and opinions on this press launch are forward-looking, which mirror the Firm’s or, as applicable, the Firm administrators’ or managements’ present expectations concerning the entry into of the mortgage facility settlement and the artificial warrant settlement with the EIB; the usage of proceeds from the mortgage facility settlement; the Genio® system and ongoing medical research of the Genio® system; the potential benefits of the Genio® system; Nyxoah’s objectives with respect to the event, regulatory pathway and potential use of the Genio® system; the utility of medical information in doubtlessly acquiring FDA approval of the Genio® system; reporting information from Nyxoah’s DREAM U.S. pivotal trial; submitting for FDA approval; and entrance to the U.S. market. By their nature, forward-looking statements contain a lot of dangers, uncertainties, assumptions and different elements that would trigger precise outcomes or occasions to vary materially from these expressed or implied by the forward-looking statements. These dangers, uncertainties, assumptions and elements might adversely have an effect on the result and monetary results of the plans and occasions described herein. Moreover, these dangers and uncertainties embrace, however will not be restricted to, the dangers and uncertainties set forth within the “Danger Components” part of the Firm’s Annual Report on Type 20-F for the 12 months ended December 31, 2023, filed with the Securities and Trade Fee (“SEC”) on March 20, 2024, and subsequent experiences that the Firm recordsdata with the SEC. A large number of things together with, however not restricted to, adjustments in demand, competitors and expertise, could cause precise occasions, efficiency or outcomes to vary considerably from any anticipated improvement. Ahead trying statements contained on this press launch concerning previous tendencies or actions will not be ensures of future efficiency and shouldn’t be taken as a illustration that such tendencies or actions will proceed sooner or later. As well as, even when precise outcomes or developments are according to the forward-looking statements contained on this press launch, these outcomes or developments might not be indicative of outcomes or developments in future intervals. No representations and warranties are made as to the accuracy or equity of such forward-looking statements. Consequently, the Firm expressly disclaims any obligation or enterprise to launch any updates or revisions to any forward-looking statements on this press launch on account of any change in expectations or any change in occasions, situations, assumptions or circumstances on which these forward-looking statements are primarily based, besides if particularly required to take action by regulation or regulation. Neither the Firm nor its advisers or representatives nor any of its subsidiary undertakings or any such particular person’s officers or workers ensures that the assumptions underlying such forward-looking statements are free from errors nor does both settle for any duty for the longer term accuracy of the forward-looking statements contained on this press launch or the precise prevalence of the forecasted developments. You shouldn’t place undue reliance on forward-looking statements, which communicate solely as of the date of this press launch.
Contacts:
Nyxoah
Loïc Moreau, Chief Monetary Officer
IR@nyxoah.com
For Media
Belgium/France
Backstage Communication – Gunther De Backer
gunther@backstagecom.be
Worldwide/Germany
MC Companies – Anne Hennecke
nyxoah@mc-services.eu
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