Sleep Apnea, Central

Nyxoah to Participate in the Oppenheimer 34th Annual Healthcare MedTech & Services Conference Mont-Saint-Guibert, Belgium – February 29, 2024, 10:30pm CET / 4:30pm 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 that the Company will participate in the Oppenheimer 34th Annual Healthcare MedTech & Services Conference, which takes place March 12 – 13, 2024. Olivier Taelman, Nyxoah’s Chief Executive Officer, will deliver a corporate presentation on Tuesday, March 12, 2024, at 10:40am ET. A webcast of the presentation will be available in the Events section of Nyxoah’s Investor Relations website. The Company will be available for 1x1 meetings with institutional investors. Nyxoah’s Investor Presentation can be accessed on the Shareholder Information section of the Company’s Investor Relations page. About Nyxoah Nyxoah is a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA). Nyxoah’s lead solution is the Genio® system, a patient-centered, leadless and battery-free hypoglossal neurostimulation therapy for OSA, the world’s most common sleep disordered breathing condition that is associated with increased mortality risk and cardiovascular comorbidities. Nyxoah is driven by the vision that OSA patients should enjoy restful nights and feel enabled to live their life to its fullest. Following the successful completion of the BLAST OSA study, the Genio® system received its European CE Mark in 2019. Nyxoah completed two successful IPOs: on Euronext Brussels in September 2020 and NASDAQ in July 2021. Following the positive outcomes of the BETTER SLEEP study, Nyxoah received CE mark approval for the expansion of its therapeutic indications to Complete Concentric Collapse (CCC) patients, currently contraindicated in competitors’ therapy. Additionally, the Company is currently conducting the DREAM IDE pivotal study for FDA and U.S. commercialization approval. For more information, please visit . Caution – CE marked since 2019. Investigational device in the United States. Limited by U.S. federal law to investigational use in the United States. Contact: Nyxoah David DeMartino, Chief Strategy Officer david.demartino@nyxoah.com +1 310 310 1313 Attachment ENGLISH_Nyxoah to Participate in the Oppenheimer 34th Annual Healthcare Conference_FINAL

New EnsoData Diagnostic AI Advances Mission to Make Healthcare More Accessible, Affordable for Patients MADISON, Wis., Feb. 26, 2024 /PRNewswire/ -- EnsoData, a pioneer in healthcare AI, achieved FDA 510(k) clearance for groundbreaking technology that enables AI-powered sleep diagnosis using FDA-cleared pulse oximetry (pulse ox) devices. Powered by EnsoSleep PPG scoring, widely available and wearable pulse ox technology can be deployed for a high quality, accessible, and cost-effective approach to diagnosing sleep disorders, including sleep apnea. Sleep apnea is a highly prevalent but often undiagnosed condition that exacerbates cardiovascular diseases like high blood pressure and congestive heart failure, neurodegenerative diseases like Alzheimer's, metabolic disorders including diabetes, stroke, and more. It is estimated that over 29.4 million Americans have sleep apnea, with more than 80% of cases still undiagnosed. With early and accurate diagnosis of sleep apnea, clinicians can help prevent complications and reduce healthcare expenses, not only saving lives but also having a profound impact on healthcare economics. EnsoSleep, EnsoData's previously FDA-cleared diagnostic AI analysis and sleep scoring solution, uses machine learning to analyze data from traditional sleep studies to aid physicians in diagnosing sleep disorders. With this new clearance, EnsoSleep PPG will provide more opportunities for clinicians to effectively reach an undiagnosed patient population by enabling AI-driven analysis using the photoplethysmogram (PPG) signals recorded by pulse oximeters. "Expanding EnsoData's capability to collect and analyze PPG signals from simple, wearable pulse ox devices will accelerate the identification, diagnosis and treatment of sleep disordered breathing events, including sleep apnea," said Justin Mortara, President and CEO of EnsoData. "With this latest FDA clearance, we expect to build upon and diversify our partner ecosystem to reach more patients with our leading AI solutions." Compared to earlier generations of sleep diagnostic equipment, pulse ox devices are smaller and less expensive. They can be as simple to wear as a ring or watch and record physiological data related to sleep and breathing, such as a patient's oxygen saturation levels and heart rate. Using this data, EnsoSleep PPG's deep learning models automatically detect respiratory events, including sleep disordered breathing events such as apneas or hypopneas, sleep stages including REM, deep sleep, light sleep, wake, and other sleep measures, which may be displayed and edited by a qualified healthcare professional and then exported into a final sleep report for a patient. By lowering the barrier for patients to receive an accurate sleep test to more widely available pulse ox devices, clinicians can expedite the diagnostic process and provide patients with answers to their health problems more quickly. "Our interoperable AI tools are democratizing the ability to accurately measure sleep and aid in diagnosis of sleep disorders broadly – for the existing category of FDA-cleared pulse oximetry devices and sensors that are already widely deployed, in-use clinically, and growing in their adoption daily. With PPGs among the most commonplace of medical waveforms collected across healthcare settings, from diagnostic tests to bedside monitors and consumer wearables, this will be transformative for patient access and outcomes to achieve better sleep and overall health," said Chris Fernandez, Co-founder and CRO of EnsoData. "This FDA clearance marks a pivotal moment in sleep diagnostics, and also long-term therapy monitoring and management, where enhanced accessibility and affordability can create a new normal in sleep care." About EnsoData: EnsoData is a healthcare technology company that uses artificial intelligence (AI) and machine learning (ML) technology to perform complex and time-consuming data interpretation and analysis to help diagnose and treat health conditions. Initially cleared by the FDA in 2017 and expanded in 2021, EnsoData's sleep scoring and study management solution, EnsoSleep, uses AI to analyze the waveforms recorded by in-lab polysomnography (PSG) and home sleep apnea testing (HSATs). With the new clearance of EnsoSleep PPG, EnsoData adds the ability to AI score data provided by FDA-cleared pulse oximeters. EnsoSleep Study Management produces an annotated, scored, and editable sleep study report physicians and other clinicians use to make faster, more accurate diagnoses of sleep disorders. EnsoData has supported more than 1,300,000 patients across leading providers and health systems, including CommonSpirit Health, Rush University, Advanced Sleep Management, Sanford Health, Jiva Health, and UCHealth, resulting in more time for clinicians to expand patient care and improve patient outcomes. Learn more at ensodata.com. SOURCE EnsoData

By utilising EnsoSleep PPG scoring, pulse oximetry technology is expected to offer a high-quality, accessible, and cost-effective method for diagnosing sleep disorders, including sleep apnoea FDA clears EnsoData's AI-powered sleep diagnosis technology. (Credit: Kelly Kirk from Pixabay) EnsoData has received the US Food and Drug Administration (FDA) 510(k) clearance for its technology that enables artificial intelligence (AI)-driven sleep diagnosis by using the regulator-cleared pulse oximetry (pulse ox) devices. By utilising EnsoSleep PPG scoring, widely accessible and wearable pulse oximetry technology can offer a high-quality, accessible, and cost-effective method for diagnosing sleep disorders, including sleep apnoea, said the company. According to EnsoData, early and precise diagnosis of sleep apnoea can help clinicians avoid complications and lower healthcare expenses. The US-based healthcare technology company also has an FDA-cleared diagnostic AI analysis and sleep scoring solution, dubbed EnsoSleep. The solution uses machine learning to analyse data from traditional sleep studies to assist physicians in the diagnosis of sleep disorders. Following the new approval, EnsoSleep PPG will facilitate AI-driven analysis of the photoplethysmogram (PPG) data acquired by pulse oximeters. This will give doctors additional opportunities to effectively reach an undiagnosed patient population, EnsoData said. EnsoData CEO Justin Mortara said: “Expanding EnsoData’s capability to collect and analyse PPG signals from simple, wearable pulse ox devices will accelerate the identification, diagnosis and treatment of sleep disordered breathing events, including sleep apnoea. “With this latest FDA clearance, we expect to build upon and diversify our partner ecosystem to reach more patients with our leading AI solutions.” Pulse oximeters are said to be more affordable and compact than the previous generations of sleep diagnostic devices. EnsoData said these devices are easy to wear as a watch or ring. They collect physiological data relating to breathing and sleep, including heart rate and oxygen saturation levels in patients. EnsoSleep PPG’s deep learning models use this data to automatically identify respiratory events. This includes sleep-disordered breathing events like apnoeas or hypopneas, as well as sleep stages and other sleep measures. These findings can then be edited and displayed by a qualified healthcare provider and exported into a patient’s final sleep report. The healthcare technology firm said that these solutions can minimise the barrier to receiving an appropriate sleep test using more commonly available pulse oximeters.