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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 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.
Nyxoah has reported its financial and operating results for Q1 2022, achieving €660,000 in revenue from the commercialization of Genio®, a significant increase from €185,000 in Q1 2021. The number of active implant sites in Germany rose by 25%, reaching 15, with plans to expand to 25 by Q3 2022. R&D expenses increased to €3.6 million due to ongoing clinical studies. The net loss for the quarter was €6.7 million, compared to €5.7 million in Q1 2021. Nyxoah maintains a strong cash position of €127.8 million, providing liquidity for its U.S. commercialization in 2024.
Nyxoah has announced the nomination of Raymond Cohen and Virginia Kirby for its Board of Directors, pending approval at the Annual Shareholders' Meeting on June 8, 2022. This follows the resignations of Don Deyo and Jan Janssen, maintaining eight board members. Cohen brings extensive experience from leading Axonics and Cardiac Science, while Kirby offers significant expertise in clinical and regulatory affairs within the medical device industry. Nyxoah specializes in solutions for Obstructive Sleep Apnea, with its Genio® system already CE marked and undergoing further FDA studies.
On June 8, 2022, NYXOAH SA (Euronext Brussels: NYXH) will hold its annual and extraordinary shareholders' meetings at 2:00 PM CET. Shareholders are encouraged to register from 1:30 PM CET, with measures in place due to COVID-19. Key agenda items include the approval of statutory annual accounts for 2021, remuneration reports, and changes to the remuneration policy to introduce share-based compensation for non-executive directors. Shareholders can participate remotely via video conference. Further details are available on the Company’s website.
Nyxoah has announced the release of its Q1 2022 financial results, scheduled for May 9, 2022, after market close. A conference call will follow on May 10, 2022, at 2:00 PM CET / 8:00 AM ET, enabling investors to discuss these results. The call can be accessed through various dialing options for attendees from the U.S., Belgium, and international locations. Nyxoah focuses on treating Obstructive Sleep Apnea with its lead solution, the Genio® system, which has received CE Mark approval and is currently under review for FDA clearance.