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 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.
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.