Nyxoah rings closing bell on Nasdaq as it prepares to launch innovative sleep apnea device in the US

Nyxoah rings closing bell on Nasdaq as it prepares to launch innovative sleep apnea device in US market

FDA regulatory filing for company’s Genio® device completed, U.S. approval on track for late 2024

US commercial launch expected early 2025, fully funded with over €85M in new capital raised

Nyxoah – NASDAQ Closing Bell Ceremony August 29, 2024

Mont-Saint-Guibert, Belgium – September 2, 2024 10:05 PM CET / 4:05 PM ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), a medical technology company focused on the development and commercialization of innovative solutions for the treatment of obstructive sleep apnea (OSA), rang the Nasdaq Closing Bell on August 29, 2024 to recognize the Company’s recent progress and highlight upcoming milestones toward the U.S. market launch of its innovative, patient-centric Genio® hypoglossal nerve stimulation technology for OSA, a common and serious sleep-related breathing disorder associated with increased risk of mortality and cardiovascular comorbidities.

“We are honored to ring the Closing Bell and celebrate our recent clinical and regulatory achievements in the U.S. We are excited about the upcoming U.S. launch of our lead product, Genio,” according to Olivier Taelman, CEO of Nyxoah. “The US is the largest healthcare market globally and therefore of strategic importance to us. With robust clinical evidence from our pivotal DREAM study, solid financing and our strengthened US commercial team, we feel well positioned to enter the US market. We have submitted the final module of our PMA application to the FDA and are on track for approval in the US by the end of 2024. If approved, Genio could be available in the US as early as early 2025.”

Olivier Taelman, CEO of Nyxoah – NASDAQ Closing Bell Ceremony August 29, 2024

Recent highlights and upcoming milestones of Nyxoah’s US commercialization strategy

Announcement of positive data from the pivotal U.S. study, DREAM, involving Nyxoah’s Genio® System, an innovative hypoglossal neurostimulation therapy for obstructive sleep apnea (OSA) in spring 2024.
Final module submitted in the modular PMA submission, initiating FDA’s interactive review.
Establishing a commercial organization in the US, led by Scott Holstine as the new Chief Commercial Officer, together with key leaders in sales, marketing and market access.
The launch of Genio® in the US market is fully financed after successfully raising over €85 million in growth capital through a €48.5 million equity offering and a €37.5 million loan agreement with the European Investment Bank (EIB).
FDA approval expected by the US Food and Drug Administration by the end of 2024.
Genio® is scheduled to launch in the US market in early 2025.

To watch the broadcast of the Nasdaq Closing Bell ceremony, go to: https://www.nasdaq.com/news-and-insights/nasdaq-stock-market-bell-ceremonies

About Nyxoah

Nyxoah is a medical technology company focused on the development and commercialization of innovative solutions for the treatment of obstructive sleep apnea (OSA). Nyxoah’s lead solution is the Genio® System, a patient-centric, leadless, battery-free hypoglossal neurostimulation therapy for OSA, the world’s most common sleep-related breathing disorder associated with increased mortality and cardiovascular comorbidities. Nyxoah is driven by the vision that OSA patients should enjoy restful nights and feel empowered to live their lives to the 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 positive outcomes from the BETTER SLEEP study, Nyxoah received CE Mark for the expansion of its therapeutic indications to Complete Concentric Collapse (CCC) patients, who are currently contraindicated with competitor therapies. In addition, the company announced positive outcomes from the DREAM IDE pivotal study for FDA and U.S. commercialization approval.

For more information, please refer to the Company’s fiscal year 2023 Annual Report or visit http://www.nyxoah.com/.

Caution – CE Marked since 2019. Investigational device in the United States. Restricted by U.S. Federal law to investigational use in the United States.

Forward-looking statements

Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the current expectations of the Company or, as applicable, the Company’s directors or management with respect to the entering into of the Loan Agreement and the Synthetic Warrant Agreement with EIB; the use of proceeds from the Loan Agreement; the Genio® System and ongoing clinical studies of the Genio® System; the potential benefits of the Genio® System; Nyxoah’s goals with respect to the development, regulatory pathway and potential uses of the Genio® System; the utility of clinical data in potentially obtaining FDA clearance of the Genio® System; the reporting of data from Nyxoah’s DREAM US pivotal trial; the filing for FDA clearance; and entry into the U.S. market. Forward-looking statements, by their nature, 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. In addition, these risks and uncertainties include, but are not limited to, those set forth in the “Risk Factors” section of the Company’s Annual Report on Form 20-F for the year ended December 31, 2023 filed with the Securities and Exchange Commission (“SEC”) on March 20, 2024, 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, could cause actual events, performance or results to differ materially 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 or 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 the officers or employees of any such person 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.

Contacts:

Nyxoah
Loïc Moreau, Financial Director
[email protected]

For media
Belgium/France
Backstage Communication – Gunther De Backer
[email protected]

International/Germany
MC Services – Anne Hennecke
[email protected]