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 its participation in the Piper Sandler 33rd Annual Virtual Healthcare Conference from November 22 to December 2, 2021. CEO Olivier Taelman will participate in a fireside chat, accessible via the company's investor relations website. Nyxoah specializes in innovative solutions for Obstructive Sleep Apnea (OSA), with its lead product, the Genio® system, receiving a European CE Mark in 2019. The company is also conducting the DREAM IDE pivotal study for FDA approval to advance its offerings in the U.S.
Nyxoah Announces New CFO Appointment
Mont-Saint-Guibert, Belgium – November 8, 2021 - Nyxoah (NYSE: NYXH) appointed Loïc Moreau as its new CFO, effective January 1, 2022. Moreau joins from GSK, where he held significant finance roles. He replaces Fabian Suarez, who is leaving to become CEO of a MedTech startup. CEO Olivier Taelman expressed gratitude for Suarez's contributions, particularly during the company's IPOs on Euronext and Nasdaq. Nyxoah specializes in innovative treatments for Obstructive Sleep Apnea, and its Genio® system has achieved CE Mark approval.
Nyxoah announces participation in the Stifel 2021 Virtual Healthcare Conference on November 15, 2021. CEO Olivier Taelman will engage in a fireside chat at 4:00 pm CET/10:00 am ET. Nyxoah specializes in innovative solutions for Obstructive Sleep Apnea (OSA) and is known for its lead product, the Genio® system, a leadless and battery-free hypoglossal neurostimulation therapy. The company received its European CE Mark in 2019 and is currently pursuing FDA approval for its devices in the US through the DREAM IDE pivotal study.
Nyxoah SA has disclosed important information regarding its voting rights and share capital as of October 29, 2021. The total share capital now stands at EUR 4,407,612.69 with a total of 25,657,359 voting rights, all relating to ordinary shares. Additionally, there are 1,400,000 new securities available via 2021 ESOP Warrants, which allows holders to subscribe to these voting rights. This update aligns with the company's obligations under Belgian law concerning shareholder information.
Nyxoah SA (NYSE: NYXH) announced on October 4, 2021, the CE-Mark indication approval from DEKRA for its Genio® system to treat Complete Concentric Collapse (CCC) patients. This approval expands their market by at least 30%. The decision is based on positive findings from the BETTER SLEEP study, confirming the effectiveness of the system for CCC patients without needing prior Drug-Induced Sleep Endoscopy. This marks a significant advancement for patients previously excluded from hypoglossal nerve stimulation therapies and boosts Nyxoah's growth prospects in Europe.
Nyxoah SA announces an increase in share capital following the issuance of 27,000 new shares on September 30, 2021, pursuant to subscription rights. The total share capital is now EUR 4,388,714.69, with a total of 25,547,359 voting rights related to ordinary shares. Additionally, the company discloses information regarding various ESOP warrants that allow holders to subscribe to over 2.2 million additional shares. This announcement aligns with regulations on large shareholdings as outlined in local law.
Nyxoah has received FDA Breakthrough Device Designation for its Genio® system, aimed at treating Obstructive Sleep Apnea (OSA) in adults with Complete Concentric Collapse (CCC). This designation facilitates quicker access to innovative therapies, offering priority review and interaction with FDA experts. The designation is supported by results from the BETTER SLEEP trial, which demonstrated safety and effectiveness in OSA patients. This advancement could significantly expand Nyxoah's market potential.
Nyxoah, a medical technology company specializing in innovative solutions for Obstructive Sleep Apnea (OSA), announced its participation in the Cantor 2021 Global Healthcare Conference on September 28, 2021, at 4:00 pm CET/10:00 am ET. CEO Olivier Taelman will present virtually, and a live webcast will be available on the company’s investor relations website. Nyxoah is known for its lead product, the Genio® system, which received the European CE Mark in 2019 following the successful BLAST OSA study. The company is also conducting the DREAM IDE pivotal study for FDA approval.
On September 12, 2021, Nyxoah SA disclosed the issuance of 1,400,000 new warrants and 82,500 new shares. Following these events, the company's share capital has reached EUR 4,384,076.09 and the total number of securities carrying voting rights is now 25,520,359, all ordinary shares. The number of outstanding subscription rights includes various ESOP warrants issued between 2013 and 2021, entitling holders to subscribe to a total of 1,721,500 additional voting rights. This update is aligned with the Law of 2 May 2007 on large shareholdings.
Nyxoah SA (Nasdaq: NYXH) announced its participation in the Baird 2021 Global Healthcare Conference, scheduled for September 14, 2021. CEO Olivier Taelman and CFO Fabian Suarez will present virtually at 3:05 pm CET / 9:05 am ET. Nyxoah specializes in innovative solutions for Obstructive Sleep Apnea (OSA), with its leading product, the Genio® system, receiving CE Mark approval in 2019 following successful clinical trials. The company is currently conducting the DREAM IDE pivotal study for FDA approval and a European study to confirm the Genio® system's long-term effectiveness.
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