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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 disclosed new share capital information in a regulatory announcement dated September 30, 2022. The company reported a total share capital of EUR 4,440,069.16 and indicated that there are 25,846,279 securities carrying voting rights, consisting entirely of ordinary shares. Furthermore, it outlined the number of subscription rights for various Employee Stock Option Plans (ESOP) dating from 2016 to 2021, which entitle holders to subscribe for a total of 1,916,625 additional securities.
Nyxoah, a medical technology company specializing in solutions for Obstructive Sleep Apnea (OSA), will participate in the 17th Annual Wells Fargo Securities Healthcare Conference from September 7-9, 2022, in Everett, MA. Management will conduct one-on-one meetings with investors on September 9. The announcement comes as Nyxoah continues to advance its Genio® system, a revolutionary treatment for OSA. With CE Mark approval since 2019 and ongoing studies for FDA approval, Nyxoah aims to improve patient outcomes and expand its market presence.
Nyxoah reported strong financial results for Q2 and H1 2022, highlighted by revenues of €935,000, a 5x increase from the previous year. The company completed enrollment in the DREAM U.S. pivotal trial and plans to release 12-month clinical data in fall 2023. Furthermore, FDA approved the ACCCESS study and the Genio® 2.1 system. However, Nyxoah experienced an operating loss of €7.4 million in Q2, with R&D and SG&A expenses rising significantly. The cash position stood at €123.3 million, offering sufficient liquidity for upcoming U.S. commercialization efforts in 2024.
Nyxoah has announced a distribution agreement with Acurable to offer the AcuPebble SA100 home sleep test for Obstructive Sleep Apnea patients in Germany. This advanced wearable device captures acoustic signals for rapid diagnosis, demonstrating high sensitivity and specificity. The AcuPebble is CE marked and FDA cleared. Nyxoah aims to enhance patient access to effective OSA diagnosis and treatment. The launch is expected in Q4 2022, aligning with Nyxoah's mission to improve the quality of life for OSA patients.
Nyxoah, a medical technology company based in Belgium, has announced its participation in the Canaccord Genuity 42nd Annual Growth Conference in Boston from August 8 to 11, 2022. Olivier Taelman, CEO, will present a corporate update on August 10 at 3:30pm EDT. Investors can access the live webcast on the Company's Investor Relations website. Nyxoah specializes in solutions for Obstructive Sleep Apnea (OSA) and features the Genio® system, an innovative therapy recognized with a CE Mark since 2019.
Nyxoah SA announced the release of its Q2 and H1 2022 financial results on August 8, 2022, after market close. The healthcare company specializes in solutions for Obstructive Sleep Apnea (OSA), with its lead product, the Genio® system, already CE marked. Following positive study outcomes, Nyxoah expanded its therapeutic indications, enhancing its market position. Investors can join a conference call on the same day at 10:30pm CET / 4:30pm ET to discuss the results. For further details, visit the investor relations page.
Nyxoah has announced the CE Mark Approval for its next-generation Genio® 2.1 system, enhancing the treatment of Obstructive Sleep Apnea (OSA)
Nyxoah has received FDA Investigational Device Exemption (IDE) approval to begin the ACCCESS study for its Genio® system, aimed at treating adult patients with moderate-to-severe Obstructive Sleep Apnea (OSA) and Complete Concentric Collapse (CCC) of the soft palate. This clinical trial will involve up to 106 patients, with key endpoints assessed at 12 months post-implant. The first patient implant is expected in Q4 2022. This marks a significant advancement in the treatment options for CCC patients who have not benefitted from CPAP therapy.
Mont-Saint-Guibert, Belgium, June 30, 2022 – Nyxoah SA (Euronext Brussels and Nasdaq: NYXH) has disclosed information per article 15 of the Law of 2 May 2007 regarding its capital structure. The updated share capital stands at EUR 4,438,351.16, with the total number of voting rights amounting to 25,836,279 (all ordinary shares). The press release also details the unissued rights to subscribe to various securities, totaling 1,932,125 from different ESOP warrants, enhancing future voting rights potential.
Nyxoah, a medical technology company focused on Obstructive Sleep Apnea, has joined the Euronext Tech Leaders Initiative as of June 7, 2022. This initiative includes over 100 high-growth technology companies with a collective market capitalization exceeding 1 trillion Euros. Nyxoah's inclusion in the Euronext Tech Leaders Index provides benefits such as improved trading conditions for retail investors and enhanced international visibility. The company is known for its Genio® system, a hypoglossal neurostimulation therapy that received CE Mark approval in 2019 and is currently undergoing FDA pivotal study.
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