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Nyxoah to Release Second Quarter 2025 Financial Results on August 18, 2025
Globenewswire· 2025-07-29 20:30
Company Overview - Nyxoah is a medical technology company focused on developing and commercializing innovative solutions for Obstructive Sleep Apnea (OSA) through neuromodulation [4] - The company's lead product is the Genio® system, which is a patient-centered, leadless, and battery-free hypoglossal neurostimulation therapy for OSA [4] Financial Results Announcement - Nyxoah will release its financial results for the second quarter of 2025 on August 18, 2025 [1] - A conference call will be hosted by company management on the same day to discuss the financial results, starting at 10:30 PM CET / 4:30 PM ET [1] Webcast Information - A webcast of the earnings call will be available on the Investor Relations page of Nyxoah's website [2] - For participants wishing to ask questions, registration is required to receive dial-in details and a unique access code [3] Recent Developments - The Genio® system received its European CE Mark in 2019 following the successful completion of the BLAST OSA study [5] - Nyxoah has completed two successful IPOs, one on Euronext Brussels in September 2020 and another on NASDAQ in July 2021 [5] - The company received CE mark approval for expanding therapeutic indications to Complete Concentric Collapse (CCC) patients after positive outcomes from the BETTER SLEEP study [5]
Nyxoah's DREAM Pivotal Study Data Published in the Journal of Clinical Sleep Medicine
Globenewswire· 2025-07-28 20:05
Core Insights - Nyxoah's DREAM pivotal study data has been published, demonstrating the safety and efficacy of the Genio® system for treating Obstructive Sleep Apnea (OSA) [1][2][4] Study Results - The DREAM study showed that over 70% of nights had device usage greater than 4 hours in 84.3% of participants, with 85.9% using the device over 70% of the nights [2] - Patient satisfaction with the therapy was reported at 90%, and snoring scores decreased from 83.5% at baseline to 30.4% at 12 months [3] - The study achieved co-primary endpoints with an AHI responder rate of 63.5% (p=0.002) and an ODI responder rate of 71.3% (p<0.001) [4][5] Device Performance - The Genio® system resulted in a median AHI reduction of 66.6% in supine positions and 70.8% across all sleeping positions at 12 months [5] - Quality of life improvements were noted, with a mean increase of 2.3 points in the Functional Outcomes of Sleep Questionnaire and a reduction of 3.4 points in the Epworth Sleepiness Score [6] Company Overview - Nyxoah focuses on innovative solutions for OSA, with the Genio® system being a leadless and battery-free hypoglossal neurostimulation therapy [7] - The company received its European CE Mark in 2019 and has completed successful IPOs on Euronext Brussels and NASDAQ [8]
Nyxoah to Present at the Jefferies Global Healthcare Conference
Globenewswire· 2025-05-28 20:30
Company Overview - Nyxoah is a medical technology company focused on developing innovative solutions for Obstructive Sleep Apnea (OSA) [4] - The company's lead product is the Genio® system, which is a leadless and battery-free hypoglossal neurostimulation therapy for OSA [4] Recent Developments - Nyxoah will participate in the Jefferies Global Healthcare Conference from June 3 to June 5, 2025, in New York [2] - CEO Olivier Taelman will present on June 4, 2025, at 4:55 PM ET, with a webcast available on the company's Investor Relations website [3] - The company will also hold one-on-one meetings with institutional investors during the conference [3] Product Milestones - The Genio® system received its European CE Mark in 2019 following the successful completion of the BLAST OSA study [5] - Nyxoah has completed two successful IPOs: on Euronext Brussels in September 2020 and NASDAQ in July 2021 [5] - The company received CE mark approval for expanded therapeutic indications to treat Complete Concentric Collapse (CCC) patients, which are currently contraindicated in competitors' therapies [5] - Positive outcomes from the DREAM IDE pivotal study have also been announced [5]
Nyxoah Reports First Quarter Financial and Operating Results
GlobeNewswire News Room· 2025-05-14 05:00
Core Insights - Nyxoah is on track for anticipated PMA approval of its Genio® system in the second quarter of 2025, having successfully completed FDA validation requirements and currently undergoing final site inspection [2][4][17] - The company reported a revenue of €1.1 million for Q1 2025, a decrease from €1.2 million in Q1 2024, with a gross profit margin of 61.8% [5][10][11] - Significant increases in research and development expenses (€9.0 million) and selling, general and administrative expenses (€12.4 million) were noted, contributing to an operating loss of €20.6 million for Q1 2025 [12][13][14] Financial Performance - Revenue for Q1 2025 was €1.1 million, down from €1.2 million in Q1 2024 [10] - Cost of goods sold was €406,000, resulting in a gross profit of €658,000 [11] - Research and development expenses rose to €9.0 million from €7.2 million year-over-year [12] - Selling, general and administrative expenses increased to €12.4 million from €6.0 million year-over-year [13] - The operating loss for Q1 2025 was €20.6 million, compared to €12.2 million in Q1 2024 [14] Cash Position - As of March 31, 2025, cash, cash equivalents, and financial assets totaled €63.0 million, down from €85.6 million at the end of 2024 [15] Regulatory Progress - The FDA issued an Approvable Letter for Nyxoah's PMA application for the Genio® system, indicating that the application meets the necessary requirements [6][17] - The final step before full PMA approval is an on-site inspection of the U.S. manufacturing site, which has already passed a previous inspection with no deficiencies [4][18] Company Overview - Nyxoah focuses on developing innovative solutions for Obstructive Sleep Apnea (OSA), with its lead product being the Genio® system, a hypoglossal neurostimulation therapy [21] - The company received its European CE Mark for the Genio® system in 2019 and has conducted successful IPOs on Euronext Brussels and NASDAQ [22]
INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Nyxoah S.A. - NYXH
GlobeNewswire News Room· 2025-04-07 13:33
Core Viewpoint - Pomerantz LLP is investigating potential securities fraud or unlawful business practices involving Nyxoah S.A. and its officers or directors [1] Company Developments - On March 25, 2025, Nyxoah announced that the FDA issued an Approvable Letter for its Pre-Market Approval application for the Genio® system, indicating that the application substantially meets regulatory requirements [3] - The FDA's approval is contingent upon satisfactory completion of a review of manufacturing facilities, methods, and controls [3] - Following this announcement, analysts projected a delay in the commercial launch of the Genio system pending further FDA review [3] Market Reaction - Nyxoah's stock price fell by $2.42 per share, or 21.36%, closing at $8.91 per share on March 26, 2025, in response to the news [4]
Nyxoah S.A. Investors: Company Investigated by the Portnoy Law Firm
GlobeNewswire News Room· 2025-03-31 21:40
Core Viewpoint - Nyxoah S.A. is under investigation for possible securities fraud following a significant stock price decline after the FDA's Approvable Letter regarding its Genio® system [1][4]. Group 1: Company Announcement - On March 25, 2025, Nyxoah announced that the FDA issued an Approvable Letter for its Pre-Market Approval application for the Genio® system, indicating that the application substantially met regulatory requirements [3]. - Final approval from the FDA is pending a satisfactory review of Nyxoah's manufacturing facilities, methods, and controls [3]. Group 2: Market Reaction - Following the FDA announcement, analysts predicted a delay in the commercial launch of the Genio® system, leading to a stock price decline of $2.42 per share, or 21.36%, closing at $8.91 on March 26, 2025 [4]. Group 3: Legal Actions - The Portnoy Law Firm has initiated an investigation into Nyxoah for possible securities fraud and may file a class action on behalf of investors who incurred losses [1]. - Investors are encouraged to contact the law firm for a complimentary case evaluation and to discuss options for recovering their losses [2][5].