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Nyxoah SA (NYSE: NYXH) is a pioneering health technology company focused on innovative treatments for sleep disordered breathing, particularly Obstructive Sleep Apnea (OSA). This page serves as the definitive source for official updates about their FDA-cleared Genio neurostimulation system, financial developments, and clinical research progress.
Investors and medical professionals will find curated press releases covering regulatory milestones, partnership announcements, and quarterly earnings reports. All content is sourced directly from company filings and verified channels to ensure accuracy.
Key focus areas include updates about international market expansions, clinical trial outcomes for OSA therapies, and technological enhancements to the Genio platform. Bookmark this page to stay informed about Nyxoah's progress in developing patient-centric solutions for chronic sleep conditions.
Nyxoah SA (NYXH), a medical technology company focused on innovative solutions for Obstructive Sleep Apnea (OSA), has announced the release of its second quarter and first half 2024 financial results on August 6, 2024, after market close. The company will host a conference call to discuss the financial results on the same day at 10:30pm CET / 4:30pm ET.
Investors and interested parties can access the earnings call webcast through the Investor Relations page of Nyxoah's website or via a provided link. Those planning to ask questions during the call are advised to register separately using a different link. Registration is recommended at least 10 minutes before the call starts to ensure proper connection. An archived version of the webcast will be available for replay shortly after the call concludes.
Nyxoah SA (NYXH) has appointed Scott Holstine as Chief Commercial Officer to lead the company's commercial operations and enable a successful U.S. launch of its Obstructive Sleep Apnea (OSA) treatment. Holstine brings 26 years of experience in the medical device industry, with expertise in U.S. product launches and building commercial organizations. The appointment is important as Nyxoah expects FDA approval by the end of 2024 and aims to have a fully operational commercial team by year-end.
CEO Olivier Taelman emphasized the importance of this hire in accelerating Nyxoah's U.S. go-to-market strategy. Holstine, a West Point graduate with an MBA from the University of Minnesota, expressed enthusiasm about joining Nyxoah, citing the company's strong DREAM study results and Genio's success in markets outside the U.S. as indicators of the technology's potential in the Hypoglossal Nerve Stimulation (HGNS) field.
On July 3, 2024, Nyxoah announced a €37.5 million loan agreement with the European Investment Bank (EIB), supported by the European Commission’s InvestEU program. The funding will facilitate research and development and scale up manufacturing to meet demands in Europe and the U.S. The loan is divided into three tranches: €10 million, €13.75 million, and €13.75 million, each carrying a 5% cash and 5% capitalized interest rate with a five-year repayment schedule.
Conditions apply for fund disbursement, and a synthetic warrant agreement is intended, granting EIB synthetic warrants based on tranche-specific formulas. Each tranche's maturity determines warrant exercise dates, with initial expectations for 468,384 synthetic warrants for Tranche A at an €8.11 strike price. The loan agreement and synthetic warrant terms tied to control changes will be submitted for shareholder approval.
CEO Olivier Taelman highlighted the combined access to over €80 million in capital, emphasizing the support’s role in commercializing Genio and expanding production.
Nyxoah, a medical technology company, announced the submission of the fourth and final module of its Premarket Approval (PMA) application for the Genio system to the U.S. FDA. Genio, a non-implanted, leadless HGNS solution, treats Obstructive Sleep Apnea (OSA) and offers patients a fully-body MRI compatible, wearable-powered device. The DREAM U.S. pivotal study showed significant reductions in the 12-month AHI and ODI responder rates. Plans for a U.S. launch by the end of 2024 are underway, with complete DREAM data to be presented in September at the International Surgical Sleep Society meeting.
Nyxoah SA (Euronext Brussels and Nasdaq: NYXH) has disclosed updated information regarding its share capital and voting rights as of June 28, 2024. The company now reports a share capital of EUR 5,904,962.41 with a total of 34,373,015 ordinary shares carrying voting rights. Additionally, there are rights to subscribe to securities carrying voting rights that haven't been issued yet. These include 50,000 shares from the 2018 ESOP Warrants, 400,500 shares from the 2020 ESOP Warrants, 1,057,625 shares from the 2021 ESOP Warrants, and 698,875 shares from the 2022 ESOP Warrants. This information is released in compliance with article 15 of the Law of 2 May 2007 on the disclosure of large shareholdings.
Nyxoah, a medical technology company specializing in innovative treatments for Obstructive Sleep Apnea (OSA), will participate in the Jefferies Global Healthcare Conference on June 5-6, 2024, in New York. CEO Olivier Taelman will present on June 5 at 7:30 am ET. The presentation will be webcast and available on Nyxoah's Investor Relations website. The company will also hold 1-on-1 meetings with institutional investors. Lyxoah’s Investor Presentation is available in the Shareholder Information section of its Investor Relations page.
Nyxoah SA, listed on Euronext Brussels and Nasdaq under the symbol NYXH, disclosed updated information on its share capital and voting rights as of June 3, 2024. The company reported a share capital of EUR 5,902,793.43, with a total of 34,360,390 ordinary shares, each carrying one voting right.
Additionally, there are warrants issued under various ESOP programs from 2018 to 2022, potentially adding 2,221,000 ordinary shares to the total number of voting rights. This information complies with Article 15 of the Law of 2 May 2007, regarding the disclosure of large shareholdings.
On June 3, 2024, Nyxoah announced the receipt of four transparency notifications in compliance with Belgian law. This follows significant changes in shareholding.
FMR acquired 4.99% of voting rights, crossing the 3% threshold. BlackRock Inc. also crossed the 3% threshold and now holds 3.28% of voting rights.
Together Partnership and Gilde Healthcare passively decreased their holdings below the 10% threshold to 8.63% and 8.62%, respectively.
These notifications reflect notable shifts in Nyxoah's shareholder base.
On May 31, 2024, Nyxoah, a medical technology company focused on treating Obstructive Sleep Apnea (OSA), announced the closing of an underwritten public offering in the United States. The offering included both public and private shares, raising $50 million (EUR 45.9 million) from 5,374,755 shares at $9.25 (EUR 8.54) per share. Furthermore, underwriters exercised their option to purchase an additional 300,000 shares, bringing total gross proceeds to $52.5 million (EUR 48.5 million). The proceeds will be used for commercialization in the U.S., clinical research, R&D for the Genio system, and general corporate purposes. The closing for the additional shares is expected on June 3, 2024, subject to customary closing conditions. Cantor Fitzgerald & Co. acted as the sole book-running manager, and Degroof Petercam was the co-manager.
On May 28, 2024, Nyxoah announced updates regarding its share capital and voting rights, following the issuance of new shares. As per Belgian law, the total share capital now stands at EUR 5,851,253.43.
The company has 34,060,390 ordinary shares, each carrying a voting right. Additionally, there are rights to subscribe to unissued securities under various Employee Stock Option Plans (ESOPs), which could potentially add 2,222,500 voting securities if fully exercised.
This disclosure aligns with regulatory requirements to keep shareholders informed about changes in capital structure.
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