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Nyxoah SA Ordinary Shares (symbol: NYXH) is at the forefront of medical technology, focusing on innovative solutions to address Obstructive Sleep Apnea (OSA). The company is committed to enhancing the lives of individuals suffering from sleep-disordered breathing conditions through its state-of-the-art products and services.
Nyxoah's flagship product, the Genio system, is a CE-Mark validated, bilateral neurostimulation therapy designed to treat moderate to severe OSA. This user-centered system provides an effective and non-invasive treatment option for a condition that has been linked to increased mortality risks and various comorbidities, including cardiovascular diseases, depression, and stroke.
The Genio system stands out in the market due to its unique approach, focusing on bilateral stimulation to open the airway during sleep, thereby improving the quality of life for patients. The development and commercialization of this innovative platform underscore Nyxoah's commitment to addressing critical health issues with cutting-edge technology.
Recent achievements of Nyxoah include advancements in clinical trials, expansion into new markets, and strategic partnerships that underscore the company's growth potential and dedication to innovation. Financially, Nyxoah has shown resilience and strategic foresight, ensuring robust investment in research and development to maintain its competitive edge.
Nyxoah continually updates its stakeholders with the latest company news, ensuring transparency and fostering investor confidence. With its headquarters in Belgium, Nyxoah is well-positioned to expand its global presence and continue its mission of providing effective solutions for OSA and related conditions.
Stay informed with the latest updates and developments from Nyxoah to keep track of their performance, events, and strategic initiatives.
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.
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