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Nyxoah SA (NYXH) is a medical technology company that develops and commercializes neuromodulation-based therapies for obstructive sleep apnea (OSA), centered on its Genio hypoglossal neurostimulation system. The Nyxoah news feed on Stock Titan brings together company-issued announcements, regulatory disclosures and market updates that reflect how the business is progressing in its target markets.
Investors following Nyxoah’s news can track updates on U.S. and European commercialization of the Genio system, including surgeon training, account activations and the completion of commercial implants. Company press releases describe milestones such as the commercial launch of Genio in new countries, early U.S. implant activity after FDA approval, and developments in reimbursement coverage with public and private payers.
Nyxoah also regularly reports on its financial position and capital markets activity. News items include quarterly financial and operating results, preliminary revenue updates, private placements, registered direct offerings and convertible bond financings, as well as information on voting rights, share capital and transparency notifications regarding significant shareholdings. These disclosures provide context on how the company funds its commercialization and research plans.
In addition, the news stream features regulatory and legal developments, such as FDA approval of the Genio system for a defined subset of adult OSA patients, CE mark expansions, and intellectual property litigation updates referenced in company filings. By reviewing the NYXH news page, readers can see how Nyxoah communicates progress on clinical, regulatory, commercial and financing fronts over time.
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.
Nyxoah, a medical technology company focusing on obstructive sleep apnea (OSA) treatments, announced the pricing of its underwritten public offering. The offering includes 5,374,755 ordinary shares at $9.25 per share, potentially raising approximately $50 million. Additionally, underwriters have a 30-day option to purchase up to 806,213 more shares. The offering aims to fund U.S. pre-commercialization activities, clinical data gathering, research, and general corporate purposes. The closing is expected on May 28, 2024, contingent upon customary conditions. Cantor Fitzgerald & Co. is the sole book-running manager, with Degroof Petercam as co-manager.