Welcome to our dedicated page for NYXOAH S A news (Ticker: NYXH), a resource for investors and traders seeking the latest updates and insights on NYXOAH S A stock.
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 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.
Nyxoah reported significant growth in its full-year 2021 results, generating revenue of €852,000 from the Genio® system commercialization, up from €69,000 in 2020, achieving a gross margin of 64.4%. The company made strides in Germany with a DRG code and secured reimbursement in Spain, while expanding its addressable market by 30% after receiving expanded CE mark approval. Despite a net loss of €27.6 million, up from €12.2 million in 2020, Nyxoah's cash position improved to €135.5 million after a successful IPO, positioning the company for continued operational momentum in 2022.
Nyxoah announced that its BETTER SLEEP clinical trial met its primary endpoint, demonstrating the effectiveness of hypoglossal nerve stimulation (HGNS) for treating patients with Complete Concentric Collapse (CCC) of the soft palate. The trial involved 42 moderate-to-severe obstructive sleep apnea patients, with a statistically significant reduction in apnea-hypopnea index (AHI4) of 11 points at six months. Over 60% responder rates were achieved across patient cohorts. The company aims for expanded therapeutic indications and ongoing collaboration with the FDA for clinical trials in the U.S.
Nyxoah SA announced its participation in the Oppenheimer 32nd Annual Healthcare Conference, scheduled for March 15-17, 2022. The company will present virtually with CEO Olivier Taelman providing a corporate update on March 16 at 10:40 am EST. Nyxoah specializes in innovative solutions for Obstructive Sleep Apnea (OSA) treatment, notably through its lead product, the Genio® system. This system received its CE Mark in 2019 and is currently being studied for FDA approval. Investors can access the live webcast and updated presentations via the company's investor relations page.
Nyxoah announced its participation at the World Sleep Congress 2022 in Rome, Italy, from March 11-16, 2022. The company will present data from its BETTER SLEEP clinical trial on March 14 and hold several physician events. The Genio® system, a breakthrough treatment for Obstructive Sleep Apnea (OSA), was highlighted. Nyxoah aims to improve therapies for patients with Complete Concentric Collapse (CCC) and is working towards securing FDA approval for clinical trials for CCC patients in the U.S.
Nyxoah SA will announce its 2021 financial results on March 24, 2022, after market close. A conference call for discussion is scheduled for March 25, 2022, at 2:00 PM CET / 8:00 AM ET. Investors can join by phone or via the company's investor relations website. Nyxoah specializes in treating Obstructive Sleep Apnea with its innovative Genio® system, which received CE Mark approval in 2019 and is currently under study for FDA approval.
Nyxoah SA has disclosed updated information on its voting rights and share capital as of February 11, 2022. The total share capital stands at EUR 4,431,664.69, with 25,797,359 ordinary shares now carrying voting rights. Furthermore, the company has several outstanding subscription rights, including 55 warrants from 2016 for 27,500 shares, 100 warrants from 2018 for 50,000 shares, 490,500 warrants from 2020 for 490,500 shares, and 1,400,000 warrants from 2021. This update complies with Article 15 of the Law of 2 May 2007 on large shareholdings.
Nyxoah SA (NASDAQ: NYXH) announced its participation in the virtual BTIG MedTech, Digital Health, Life Science & Diagnostic Tools Conference from February 15-17, 2022. CEO Olivier Taelman will deliver a corporate update on February 17, 2022, at 8:00 AM EST. The presentation will not be webcast, but Nyxoah will hold virtual 1x1 meetings with registered institutional investors. The company specializes in innovative treatments for Obstructive Sleep Apnea (OSA), with its lead product, Genio®, receiving CE Mark approval after the successful completion of the BLAST OSA study.
Nyxoah announced updates following a transformational 2021 that set the stage for advances in 2022. Key highlights include:
- 15 U.S. patient sites active in the DREAM IDE pivotal study.
- Secured CE Mark MR conditional labeling for Genio® system.
- Raised $97.8 million from a Nasdaq IPO.
- FDA Breakthrough Device Designation granted for OSA treatment.
- Expanded CE Mark indication, increasing market potential by over 30%.
- Strong commercial progress in Germany and Switzerland.
CEO Olivier Taelman expressed optimism for continued growth and market leadership.
Nyxoah SA disclosed its current share capital and voting rights information following the exercise of subscription rights. As of November 26, 2021, the share capital stands at EUR 4,427,369.69, with a total of 25,772,359 ordinary shares carrying voting rights. Additionally, the report outlines outstanding subscription rights from previous employee stock option plans, including a total of 1,400,000 securities available through the 2021 ESOP Warrants, issued on September 8, 2021. This transparency complies with the Law on the disclosure of large shareholdings.
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