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Nyxoah Reports Fourth Quarter and Financial Year 2024 Financial and Operating Results
Newsfilter· 2025-03-13 06:00
REGULATED INFORMATION Nyxoah Reports Fourth Quarter and Financial Year 2024 Financial and Operating ResultsFDA PMA Application Review Nearing ConclusionPositioned for U.S. Commercial Launch in March 2025 Mont-Saint-Guibert, Belgium – March 13, 2024, 7:00am CET / 2:00am ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) ("Nyxoah" or the "Company"), that develops breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA) through neuromodulation, today reported financial and operating results for the f ...
Nyxoah Reports Fourth Quarter and Financial Year 2024 Financial and Operating Results
GlobeNewswire News Room· 2025-03-13 06:00
Core Insights - Nyxoah reported financial and operational results for Q4 and FY 2024, highlighting a transformative year with significant advancements in their product and market strategy [1][3][4] Financial Performance - Q4 2024 revenue was €1.3 million, with deferred revenue accounting for €0.6 million; without this deferral, revenue would have been €1.9 million, a 46% increase from Q3 2024 [4] - Full year 2024 revenue reached €4.5 million, an 18% increase from €4.3 million in 2023, driven by the commercialization of the Genio® system, particularly in Germany [4] - Gross profit for Q4 2024 was €0.9 million, resulting in a gross margin of 73%, compared to a gross margin of 60% in Q4 2023 [5][6] - Total operating loss for Q4 2024 was €18.3 million, up from €10.8 million in Q4 2023, primarily due to increased R&D and commercial expenses [10] Research and Development - R&D expenses for Q4 2024 were €11.7 million, compared to €7.3 million in Q4 2023; for the full year, R&D expenses totaled €34.3 million, up from €26.7 million in 2023 [7] Selling, General and Administrative Expenses - Selling, general and administrative expenses for Q4 2024 were €8.1 million, an increase from €4.9 million in Q4 2023; for the full year, these expenses were €28.5 million, compared to €21.7 million in 2023 [8][9] Cash Position - As of December 31, 2024, cash and financial assets totaled €85.6 million, an increase from €57.7 million at the end of 2023 [11] Market Position and Future Outlook - The company is positioned for a U.S. commercial launch of the Genio® system in March 2025, with FDA approval expected by the end of Q1 2025 [1][3]
Nyxoah to Release Fourth Quarter and Financial Year 2024 Financial Results on March 13, 2025
GlobeNewswire· 2025-03-10 21:05
Nyxoah to Release Fourth Quarter and Financial Year 2024 Financial Results on March 13, 2025 Mont-Saint-Guibert, Belgium – Monday, March 10, 2025, 10:05pm CET / 5:05pm ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), that develops breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA) through neuromodulation, today announced that the Company will release financial results for the fourth quarter and financial year 2024 on Thursday, March 13, 2025. Company management ...
Nyxoah to Participate in the Oppenheimer 35th Annual Healthcare MedTech & Services Conference
GlobeNewswire· 2025-03-03 21:30
Core Insights - Nyxoah will participate in the Oppenheimer 35 Annual Healthcare MedTech & Services Conference from March 17 to 20, 2025 [1] - CEO Olivier Taelman will present on March 17, 2025, at 8:40am ET, with a webcast available for investors [2] - The company focuses on innovative treatments for Obstructive Sleep Apnea (OSA) through neuromodulation [3] Company Overview - Nyxoah develops breakthrough treatment alternatives for OSA, with its first product being the Genio® device, which is battery-free and inserted through a single incision [3] - The Genio® system received its European CE Mark in 2019 after the successful BLAST OSA study [4] - The company has completed two IPOs, one on Euronext Brussels in September 2020 and another on NASDAQ in July 2021 [4] - Following positive outcomes from the BETTER SLEEP study, Nyxoah expanded its therapeutic indications to include Complete Concentric Collapse (CCC) patients [4] - The company also announced positive results from the DREAM IDE pivotal study, which is aimed at FDA and U.S. commercialization approval [4]
Nyxoah Announces Commercial Launch of Genio® Breakthrough Therapy in the Middle East
GlobeNewswire News Room· 2025-02-19 06:05
Core Insights - Nyxoah has announced the commercial launch of its Genio system in the Middle East, with the first successful implant performed at Saudi German Hospital in Dubai [1][2] - The Genio system is a breakthrough therapy for Obstructive Sleep Apnea (OSA) that utilizes neuromodulation and is designed for patients who cannot tolerate CPAP [2][3] - The launch represents a historic milestone as the first neurostimulation therapy for OSA in the region, aiming to expand access and transform treatment options for patients [2][4] Company Overview - Nyxoah is a medical technology company focused on developing innovative treatment alternatives for OSA through neuromodulation [3] - The Genio device is a battery-free hypoglossal neuromodulation system that is inserted through a single incision and controlled by a wearable device [3] - The company has demonstrated best-in-class outcomes for reducing the burden of OSA through its commitment to innovation and clinical evidence [3] Regulatory and Market Developments - 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, first on Euronext Brussels in September 2020 and then on NASDAQ in July 2021 [4] - The company has received CE mark approval for expanding therapeutic indications to patients with Complete Concentric Collapse (CCC), which are currently contraindicated in competitors' therapies [4]
Nyxoah Announces Commercial Launch of Genio® Breakthrough Therapy in the Middle East
GlobeNewswire· 2025-02-19 06:05
Nyxoah Announces Commercial Launch of Genio® Breakthrough Therapy in the Middle EastFirst patient implanted with Genio at Saudi German Hospital in Dubai, United Arab Emirates Mont-Saint-Guibert, Belgium – February 19, 2025, 7:05am CET / 1:05am ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), a medical technology company that develops breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA) through neuromodulation, today announced the commercial launch of its Genio s ...
Nyxoah: The Future Of OSA
Seeking Alpha· 2024-12-30 09:01
Group 1 - The company Nyxoah is expected to revolutionize the treatment of Obstructive Sleep Apnea with its Genio implant, pending FDA approval in Q1 2025, which could act as a catalyst for share price movement [3] - The investment focus is on undervalued and disliked companies with strong fundamentals and cash flows, particularly in sectors like Oil & Gas and consumer goods [1] - The analyst expresses a long-term value investing approach while also engaging in deal arbitrage opportunities, indicating a diverse investment strategy [1] Group 2 - The article emphasizes the importance of connecting with like-minded investors to share insights and foster a collaborative investment community [1] - There is a clear preference for companies and industries that are misunderstood or overlooked, suggesting potential for substantial returns [1] - The analyst has a beneficial long position in Nyxoah, indicating confidence in the company's future performance [4]
Nyxoah Announces Commercial Launch of Genio® Innovative Therapy in England
GlobeNewswire News Room· 2024-12-13 07:05
Core Insights - Nyxoah has announced the commercial launch of its Genio system in England, with successful implants performed at University College London Hospitals (UCLH) [1][3] - The Genio system is now covered under the NHS Specialised Services Devices Programme (SSDP), facilitating access to innovative therapies [2] - The Genio device is a battery-free hypoglossal neuromodulation system designed to treat Obstructive Sleep Apnea (OSA) [4] Company Overview - Nyxoah is focused on developing breakthrough treatment alternatives for OSA through neuromodulation, aiming to address the needs of the billion people suffering from this condition [4] - 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] Clinical Milestones - The first two patients were implanted with the Genio system by Mr. Ryan Chin Taw Cheong at UCLH, marking a significant milestone for the company [3] - The company has received CE mark approval for expanding therapeutic indications to include Complete Concentric Collapse (CCC) patients, which are currently contraindicated in competitors' therapies [5] - Positive outcomes from the DREAM IDE pivotal study have been announced, supporting FDA and U.S. commercialization approval [5]
Nyxoah Announces Commercial Launch of Genio® Innovative Therapy in England
Newsfilter· 2024-12-13 07:05
Core Insights - Nyxoah has announced the commercial launch of its Genio system in England, with successful implants performed at University College London Hospitals (UCLH) [1][3] - The Genio system is now covered under the NHS Specialised Services Devices Programme (SSDP), facilitating access to innovative therapies [2] Company Overview - Nyxoah is a medical technology company focused on developing neuromodulation treatment alternatives for Obstructive Sleep Apnea (OSA), with its first product being the Genio system [4] - The Genio device is a battery-free hypoglossal neuromodulation device that is inserted through a single incision under the chin and controlled by a wearable [4] Clinical Milestones - The Genio system received its European CE Mark in 2019 following the successful completion of the BLAST OSA study [5] - Positive outcomes from the BETTER SLEEP study led to the expansion of therapeutic indications for Genio to include Complete Concentric Collapse (CCC) patients, which are currently contraindicated in competitors' therapies [5] - The company has also announced positive results from the DREAM IDE pivotal study, which is aimed at obtaining FDA approval for U.S. commercialization [5]
Nyxoah to Participate in the Piper Sandler 36th Annual Healthcare Conference
GlobeNewswire News Room· 2024-11-20 21:05
Core Points - Nyxoah will participate in the Piper Sandler 36th Annual Healthcare Conference on December 4, 2024, presenting at 2:00pm ET via webcast [1][2] - The company focuses on developing innovative treatment alternatives for Obstructive Sleep Apnea (OSA) through neuromodulation [3] - Nyxoah's flagship product, Genio®, is a battery-free hypoglossal neuromodulation device that has shown best-in-class outcomes for reducing OSA burden [3] Company Overview - Nyxoah aims to address the needs of the billion people suffering from OSA by providing breakthrough treatment options [3] - The Genio® system received its European CE Mark in 2019 following the successful BLAST OSA study [4] - The company has completed two successful IPOs, one on Euronext Brussels in September 2020 and another on NASDAQ in July 2021 [4] - Following positive outcomes from the BETTER SLEEP study, Nyxoah expanded its therapeutic indications to include Complete Concentric Collapse (CCC) patients, which are currently contraindicated in competitors' therapies [4] - The company also announced positive outcomes from the DREAM IDE pivotal study, which is aimed at obtaining FDA approval for U.S. commercialization [4]