Nyxoah Rings the Closing Bell at Nasdaq while Preparing for U.S. Market Launch of Innovative Sleep Apnea Device FDA regulatory submission for the Company's Genio® device is complete, U.S. approval on track for the end of 2024 U.S. commercial launch, expected at the beginning of 2025, fully funded with over €85 million in new capital raised Nyxoah – NASDAQ Closing Bell Ceremony 29 août 2024 Mont-Saint-Guibert, Belgium – September 2, 2024 10:05pm CET / 4:05PM ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (" ...

Nyxoah SA (NYXH) came out with a quarterly loss of $0.46 per share versus the Zacks Consensus Estimate of a loss of $0.45. This compares to loss of $0.49 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of -2.22%. A quarter ago, it was expected that this company would post a loss of $0.45 per share when it actually produced a loss of $0.45, delivering no surprise. Over the last four quarters, the company has surpassed consensus E ...

Company Overview - Nyxoah SA is a medical technology company focused on developing and commercializing innovative solutions for treating Obstructive Sleep Apnea (OSA) [9] - The company's lead product is the Genio® system, which is a patient-centered, leadless, and battery-free hypoglossal neurostimulation therapy for OSA [9] Financial Results Announcement - Nyxoah will release its financial results for the second quarter and first half of 2024 on August 6, 2024, after market close [1][6] - A conference call will be hosted by company management on the same day at 10:30pm CET / 4:30pm ET to discuss the financial results [1][6] Conference Call Details - Participants wishing to ask questions must register via a provided link to receive dial-in details and a unique access code [2] - The company recommends registering at least 10 minutes before the call starts to ensure connection [2] - A webcast of the call will be available on the Investor Relations page of Nyxoah's website [7]

Nyxoah Appoints Scott Holstine as Chief Commercial Officer Mont-Saint-Guibert, Belgium – July 15, 2024, 8:00am CET / 2:00am ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) ("Nyxoah" or the "Company"), a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA), today announced the appointment of Scott Holstine as Chief Commercial Officer. In this role, Scott will lead the commercial operations of Nyxoah enabling a successful U. ...

Scott brings over 26 years of experience in the medical device industry with a proven track record in U.S. product launches, building and leading commercial organizations trademarked by strong operational execution. Scott is a passionate advocate for people and talent development. Scott graduated with the Superintendent's Award for Excellence (Star Wreath) from the United States Military Academy at West Point, NY. After serving as a Captain in the U.S. Army, Scott received his MBA from the University of Min ...

Core Insights - Nyxoah has submitted the fourth and final module of its Premarket Approval (PMA) application for the Genio® system to the U.S. FDA, marking a significant step towards U.S. commercialization [4][9] - The Genio® system, which received its European CE Mark in 2019, is a leadless and battery-free hypoglossal neurostimulation therapy designed to treat Obstructive Sleep Apnea (OSA) [1][10] - The company has successfully completed two IPOs, one on Euronext Brussels in September 2020 and another on NASDAQ in July 2021 [1] Company Developments - Following the BETTER SLEEP study, Nyxoah expanded its therapeutic indications to include Complete Concentric Collapse (CCC) patients, a group currently excluded from competitors' therapies [1] - The DREAM IDE pivotal study is currently underway to support FDA approval and U.S. commercialization of the Genio® system [1][4] - The company aims to present complete DREAM study data at the International Surgical Sleep Society meeting in September 2024, with plans for a U.S. launch by the end of the year [9] Product Features - The Genio® system is characterized by its leadless design, full-body MRI compatibility, and a non-implanted battery solution, which is powered and controlled by a wearable device [10][14] - The system's wearable component is fully upgradable, allowing patients to access the latest technology without the need for additional surgeries [14] - Recent data from the DREAM U.S. pivotal study indicated a statistically significant reduction in the co-primary endpoints, including the 12-month AHI responder rate and ODI responder rate [14]

Core Insights - Nyxoah has submitted the fourth and final module of its Premarket Approval (PMA) application for the Genio system to the U.S. FDA, marking a significant milestone in the company's efforts to commercialize its innovative treatment for Obstructive Sleep Apnea (OSA) [1][5][6] Company Overview - Nyxoah is a medical technology company focused on developing and commercializing solutions for treating OSA, with its lead product being the Genio system, which is a leadless and battery-free hypoglossal neurostimulation therapy [11] - The Genio system is designed to be patient-centered and is compatible with MRI, offering a non-implanted battery solution controlled by a wearable device [10] Recent Developments - The Genio system received its European CE Mark in 2019 following the successful completion of the BLAST OSA study [7] - Nyxoah has conducted two successful IPOs, first on Euronext Brussels in September 2020 and then on NASDAQ in July 2021 [7] - The company has expanded its therapeutic indications to include Complete Concentric Collapse (CCC) patients, which are currently contraindicated in competitors' therapies [7] Clinical Studies and Data - The DREAM U.S. pivotal study data showed a statistically significant reduction in the co-primary endpoints of 12-month AHI responder rate and ODI responder rate, indicating the effectiveness of the Genio system [10] - Genio is the only hypoglossal nerve stimulation solution that has demonstrated similar outcomes in both supine and non-supine sleep positions [10] Future Plans - The company plans to present the complete DREAM data at the International Surgical Sleep Society meeting in September 2024 and aims for a U.S. launch of the Genio system by the end of the year [6]

100 "2018 ESOP Warrants" issued on December 12, 2018, entitling their holders to subscribe to a total number of 50,000 securities carrying voting rights (all ordinary shares); 400,500 "2020 ESOP Warrants" issued on February 21, 2020, entitling their holders to subscribe to a total number of 400,500 securities carrying voting rights (all ordinary shares); and 1,057,625 "2021 ESOP Warrants" issued on September 8, 2021, entitling their holders to subscribe to a total number of 1,057,625 securities carrying vot ...

Company Overview - Nyxoah is a medical technology company focused on developing and commercializing innovative solutions for treating Obstructive Sleep Apnea (OSA) [3] - The company's lead product is the Genio® system, which is a patient-centered, leadless, and battery-free hypoglossal neurostimulation therapy for OSA [3] Recent Developments - Nyxoah will participate in the Jefferies Global Healthcare Conference on June 5-6, 2024, in New York [1] - CEO Olivier Taelman will deliver a corporate presentation on June 5, 2024, at 7:30 am ET, with a webcast available on the company's Investor Relations website [2] - The company will also hold one-on-one meetings with institutional investors during the conference [2] Product Milestones - The Genio® system received its European CE Mark in 2019 following the successful completion of the BLAST OSA study [4] - Nyxoah completed IPOs on Euronext Brussels in September 2020 and NASDAQ in July 2021 [4] - The company received CE mark approval for expanding therapeutic indications to Complete Concentric Collapse (CCC) patients after positive outcomes from the BETTER SLEEP study [4] - Currently, Nyxoah is conducting the DREAM IDE pivotal study for FDA and U.S. commercialization approval [4]

REGULATED INFORMATION Publication relating to transparency notifications Mont-Saint-Guibert (Belgium), June 3, 2024, 10.05pm CET / 4.05pm ET – In accordance with article 14 of the Act of 2 May 2007 on the disclosure of large shareholdings, Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) announces that it received four transparency notifications as detailed below. FMR LLC On May 30, 2024, Nyxoah received a transparency notification from FMR LLC following the crossing above the 3% threshold on May 28, 2024. As of ...