Welcome to our dedicated page for Nyxoah SA news (Ticker: NYXH), a resource for investors and traders seeking the latest updates and insights on Nyxoah SA stock.
Nyxoah SA reports medical-technology developments tied to the Genio system, its patient-centered, leadless and battery-free hypoglossal neurostimulation therapy for obstructive sleep apnea. Company news commonly covers financial and operating results, U.S. commercialization activity, regulatory status, manufacturing capacity, reimbursement references, investor conference participation, and the development and commercialization of OSA treatment alternatives.
Nyxoah also publishes regulated information for its Euronext Brussels and Nasdaq securities, including transparency notifications, shareholder-meeting materials, voting-right disclosures, and bond-related capital-structure notices.
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)/b) in Europe. This approval, effective as of July 18, 2022, indicates that the external components of the Genio® system can now be used for patients with existing implants. The Genio® 2.1 features a smartphone app for real-time feedback and the ability for physicians to customize stimulation for improved patient comfort. The company aims to accelerate market share gains while addressing various patient needs.
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.
Nyxoah has announced FDA approval for its upgraded Genio® 2.1 system, which will be utilized in the DREAM U.S. IDE pivotal study. This new iteration introduces a smartphone application, an enhanced activation chip, and improved interface features that prioritize patient comfort and therapy compliance. Notably, the new system allows clinicians to make precise stimulation adjustments. The Genio system is designed to treat Obstructive Sleep Apnea (OSA)/b), aiming to improve patient outcomes and overall experience.
Nyxoah reports a strong start to 2022, achieving €660,000 in revenue, over three times growth year-over-year, primarily driven by its Genio® system in Germany. The company has expanded its active implant sites to 15, with plans for 10 more by Q3 2022. Monthly enrollment in the DREAM U.S. IDE study accelerated, expecting completion by Q2 2022. However, Nyxoah reported an operating loss of €7.3 million and a net loss of €6.7 million, with cash and financial assets totaling €127.8 million, down from €135.5 million at year-end.