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Nyxoah Invests In Further Expanding Its Belgian Manufacturing Capacity To Support Its Worldwide Growth
Globenewswire· 2026-01-21 21:05
Core Viewpoint - Nyxoah is making a significant investment to expand its manufacturing capacity in Belgium to support growth in the U.S. and international markets [1][2][3] Group 1: Investment and Expansion - Nyxoah has signed an agreement with LégiaPark to create a nearly 2,000 square meters manufacturing facility, including a state-of-the-art cleanroom [2] - The investment aims to enhance Nyxoah's product development activities and strengthen its strategic partnership with Noshaq, contributing to local job creation [2][3] Group 2: Manufacturing and Technology - The new cleanroom facility is designed to be scalable, allowing for future growth alongside Nyxoah's manufacturing needs [3] - ABN Cleanroom Technology is collaborating with Nyxoah to develop the cleanroom, emphasizing innovation and local expertise in Belgium [3][9] Group 3: Company Overview - Nyxoah specializes in developing innovative solutions for Obstructive Sleep Apnea (OSA), with its lead product being the Genio system, a battery-free neurostimulation therapy [4][5] - The Genio system received its European CE Mark in 2019 and has expanded its therapeutic indications following successful studies [5]
Nyxoah to Present at the 44th Annual J.P. Morgan Healthcare Conference
Globenewswire· 2025-12-29 21:05
Core Viewpoint - Nyxoah will present at the 44th Annual J.P. Morgan Healthcare Conference, highlighting its innovative treatment for Obstructive Sleep Apnea (OSA) through the Genio system [1][2]. Company Overview - Nyxoah is a medical technology company focused on developing and commercializing solutions for OSA, with its lead product being the Genio system, which is a leadless and battery-free hypoglossal neurostimulation therapy [3]. - The company aims to improve the quality of life for OSA patients, who are at increased risk for mortality and cardiovascular issues [3]. Product Development and Regulatory Approvals - The Genio system received its European CE Mark in 2019 following the successful completion of the BLAST OSA study [4]. - Nyxoah has completed two IPOs, one on Euronext Brussels in September 2020 and another on NASDAQ in July 2021 [4]. - The company expanded its therapeutic indications to include Complete Concentric Collapse (CCC) patients after positive outcomes from the BETTER SLEEP study, which are currently contraindicated in competitors' therapies [4]. - Nyxoah also announced positive results from the DREAM IDE pivotal study and received FDA approval in August 2025 for a subset of adult patients with moderate to severe OSA [4].
Nyxoah to Participate in the Piper Sandler 37th Annual Healthcare Conference
Globenewswire· 2025-11-27 21:05
Core Viewpoint - Nyxoah is actively participating in the Piper Sandler 37th Annual Healthcare Conference, showcasing its innovative solutions for Obstructive Sleep Apnea (OSA) treatment [1]. Company Overview - Nyxoah is a medical technology company focused on developing and commercializing innovative solutions for OSA, with its lead product being the Genio system, which is a leadless and battery-free hypoglossal neurostimulation therapy [3]. - The company aims to improve the quality of life for OSA patients, allowing them to enjoy restful nights [3]. Product Development and Regulatory Approvals - The Genio system received its European CE Mark in 2019 following the successful completion of the BLAST OSA study [4]. - Nyxoah has completed two successful IPOs, one on Euronext Brussels in September 2020 and another on NASDAQ in July 2021 [4]. - The company expanded its therapeutic indications to include Complete Concentric Collapse (CCC) patients after positive outcomes from the BETTER SLEEP study, which are currently contraindicated in competitors' therapies [4]. - Nyxoah announced positive results from the DREAM IDE pivotal study and received FDA approval for a subset of adult patients with moderate to severe OSA, specifically those with an Apnea-Hypopnea Index (AHI) of 15 to 65 [4].
Nyxoah Secures Financing Commitments of up to U.S. $77 Million to Drive U.S. Commercialization of Genio
Globenewswire· 2025-11-13 21:36
Core Viewpoint - Nyxoah has secured financing commitments totaling up to U.S. $77 million to support the U.S. commercialization of its Genio system, which is designed to treat Obstructive Sleep Apnea (OSA) through neuromodulation [1][2]. Financing Details - The financing includes a €22 million private placement of equity, a U.S. $5.6 million registered direct offering, and a convertible bond financing of up to €45 million [2][7]. - The private placement involves the issuance of 5,481,678 new ordinary shares at a subscription price of €4.00 per share, generating gross proceeds of approximately €25 million [3]. - The registered direct offering consists of 1,215,964 new ordinary shares priced at U.S. $4.6304 per share, totaling approximately U.S. $5.6 million [5][6]. - The convertible bonds will have a maximum principal amount of up to €45 million, with the first tranche of €22.5 million expected to close in December 2025 [7]. Use of Proceeds - The net proceeds from the financing will be allocated to support U.S. commercialization activities, gather clinical data, finance research and development, and explore collaboration opportunities in OSA monitoring and diagnostics [8]. Company Background - Nyxoah is focused on developing innovative solutions for OSA, with its lead product being the Genio system, which is a leadless and battery-free hypoglossal neurostimulation therapy [10]. - The Genio system received its European CE Mark in 2019 and FDA approval for certain adult patients in August 2025 [11][12].