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 (NYSE: NYXH) is a pioneering health technology company focused on innovative treatments for sleep disordered breathing, particularly Obstructive Sleep Apnea (OSA). This page serves as the definitive source for official updates about their FDA-cleared Genio neurostimulation system, financial developments, and clinical research progress.
Investors and medical professionals will find curated press releases covering regulatory milestones, partnership announcements, and quarterly earnings reports. All content is sourced directly from company filings and verified channels to ensure accuracy.
Key focus areas include updates about international market expansions, clinical trial outcomes for OSA therapies, and technological enhancements to the Genio platform. Bookmark this page to stay informed about Nyxoah's progress in developing patient-centric solutions for chronic sleep conditions.
Nyxoah (NASDAQ: NYXH) announced on October 6, 2025 that the first U.S. commercial patients have been implanted with the Genio® system following FDA approval. The PR states the company has trained surgeons, secured Value Analysis Committee approvals, and achieved payor coverage including CMS. Dr. Andrew T. Huang performed the initial U.S. commercial implants at Townsen Memorial Health System in Houston, completing five implants in one week. Nyxoah says it will track surgeon training, VAC submissions, prior authorizations, and accounts opened as leading indicators of future revenue growth.
Nyxoah (NASDAQ: NYXH) published a transparency notification on October 3, 2025 reporting a holding change by Vestal Point Capital.
Per the notification dated September 30, 2025, Vestal Point Capital, LP now holds 1,113,575 voting rights, representing 2.97% of total voting rights (denominator: 37,544,782) as of September 24, 2025. The filing notes a downward crossing of the 3% threshold. Vestal Point Capital, LLC is the GP controlled by Ryan Wilder; Vestal Point Capital, LP acts as investment manager and may exercise voting rights at its discretion.
Nyxoah (NASDAQ: NYXH), a medical technology company focused on Obstructive Sleep Apnea (OSA) treatment, announced the expansion of its commercial presence in the Middle East. Following the first successful Genio® implant in Abu Dhabi in September 2025, the company has established new centers across Dubai, Kuwait, and Abu Dhabi.
The Genio® system, which is the only leadless, externally powered bilateral hypoglossal nerve stimulation system for treating moderate-to-severe OSA, is now available through partnerships with leading healthcare institutions in these regions. This expansion follows the company's initial Middle East launch earlier in 2025, targeting patients who cannot tolerate CPAP therapy.
["Geographic expansion into multiple Middle East markets", "Successful first Genio implant completed in Abu Dhabi", "Partnerships established with leading healthcare institutions in the region", "Entry into world-class healthcare systems with renowned Key Opinion Leaders"]Nyxoah (NASDAQ:NYXH) has filed a patent infringement lawsuit against Inspire Medical Systems in the United States District Court for the District of Delaware. The lawsuit alleges that Inspire's IV and V devices infringe on three of Nyxoah's U.S. patents (8,700,183, 9,415,215, and 9,415,216).
The Company is seeking injunctive relief and damages, while defending its proprietary Genio® system, which features bilateral stimulation, full body MRI compatibility, and an upgradable platform that eliminates the need for battery replacement surgery. CEO Olivier Taelman highlighted positive feedback from the first month of U.S. commercial launch of the Genio system for Obstructive Sleep Apnea (OSA) treatment.
Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) announced receiving a transparency notification from Cochlear Limited and Cochlear Investments Pty Ltd following a passive threshold crossing. The notification reveals that Cochlear Investments Pty Ltd now holds 5,631,319 voting rights, representing 14.999% of total voting rights (37,544,782) as of August 29, 2025.
The change represents a passive downward crossing of the 15% threshold, with Cochlear Investments Pty Ltd's holding decreasing from 15.04% to 14.999%. Cochlear Investments Pty Ltd is a wholly owned subsidiary of Cochlear Limited, an Australian Securities Exchange-listed company with no controlling shareholder.
Nyxoah (NASDAQ: NYXH), a medical technology company focused on Obstructive Sleep Apnea (OSA) treatment, has announced its participation in four major healthcare investor conferences in September 2025.
The company will attend the Wells Fargo Healthcare Conference in Boston (Sept 3), Cantor Global Healthcare Conference in New York (Sept 4, 11:30-12:00 pm ET), Morgan Stanley Global Healthcare Conference in New York (Sept 9, 5:35-6:10 pm ET), and Baird's Global Healthcare Conference in New York (Sept 10). Live webcasts will be available on Nyxoah's Investor Relations website, and the company will conduct one-on-one meetings with institutional investors.
Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) has disclosed updated information regarding its voting rights and shares as required by Belgian law. The company reported a share capital of EUR 6,449,871.98 with 37,544,782 ordinary shares, each carrying one voting right. Additionally, there are 2,775,566 subscription rights not yet issued, excluding 493,057 subscription rights that were issued but not yet granted.
Nyxoah (NASDAQ:NYXH) has achieved a significant milestone with FDA approval of its Genio system, the first and only bilateral hypoglossal neurostimulation therapy for Obstructive Sleep Apnea (OSA) in the U.S. market. The company has initiated its commercial launch with strong Q2 2025 results, reporting revenue of €1.3 million, a 74% year-over-year increase.
The Genio system's approval was supported by the DREAM pivotal trial data, demonstrating 66.6% median AHI reduction in supine position and 71.0% reduction in non-supine position. The company's cash position stands at €43.0 million as of June 30, 2025, with an additional €27.5 million available through a term debt facility.
Operating loss increased to €19.9 million in Q2 2025, primarily due to expanded commercialization efforts and R&D activities.
Nyxoah (NASDAQ: NYXH), a medical technology company focused on Obstructive Sleep Apnea (OSA) treatment, has announced preliminary Q2 2025 results. The company achieved revenue of €1.3 million, marking a 73% year-over-year increase. Operating expenses rose 50% to €20.7 million.
Key developments include FDA approval of the Genio® system for moderate to severe OSA patients with AHI between 15 and 65. The company maintains €43.0 million in cash and equivalents, with access to an additional €27.5 million in debt facility. Nyxoah plans to conclude ACCCESS trial enrollment early while maintaining the study's co-primary endpoints. The company faces a patent infringement lawsuit from Inspire Medical Systems and is reorganizing its R&D operations from Israel to the U.S. and Belgium.
Nyxoah (NASDAQ: NYXH) has received FDA approval for its Genio® system, a breakthrough treatment for moderate to severe Obstructive Sleep Apnea (OSA). The approval covers patients with an Apnea-Hypopnea Index (AHI) between 15 and 65.
The Genio system represents a novel approach to hypoglossal nerve stimulation, featuring bilateral stimulation and a unique leadless design that is MRI compatible. The system's efficacy was demonstrated in the DREAM pivotal trial, achieving a 63.5% AHI responder rate and an impressive 70.8% median AHI reduction.
Notably, the system showed consistent effectiveness across all sleeping positions, with a 66.6% median AHI reduction in supine position and 71.0% reduction in non-supine position. The company has officially launched its U.S. commercialization efforts.
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