Latest news with #ObstructiveSleepApnea
The Sun
4 days ago
- Health
- The Sun
Sleep problem that affects 10million people in UK could trigger world's deadliest cancer, first-of-its-kind study warns
HEAVY snorers could be at risk of the world's deadliest cancer, a shock new study has revealed. Obstructive sleep apnea (OSA) has previously been linked to an increased risk of certain cancers. 1 Now, in a world-first trial, a "significant" link has been found between the condition and lung cancer. US researchers, who assessed the health records of more than 2.4 million adults, say they're not exactly sure why it raises the risk. But they believe it could be due to a lack of oxygen people with the condition get during the night - or lifestyle factors such as smoking and obesity. The findings were presented at the American Society of Clinical Oncology conference in Chicago. Scientists present urged policymakers to consider screening those with OSA for the cancer, and to tackle the condition early, soon after diagnosis. Globally, an estimated 936 million adults aged 30-69 years are affected by OSA. The condition occurs when the muscles in the throat relax too much during sleep, causing the airway to narrow or close, interrupting breathing. This can happen due to several factors, including obesity, a large neck or collar size, structural abnormalities like a small lower jaw or a large tongue, and other medical conditions. Common symptoms include breathing stopping and starting, making gasping, snorting or choking noises, waking up a lot, and loud snoring, says the NHS. According to the Sleep Apnoea Trust, as many as 10 million people in the UK suffer from OSA – with up to four million of these suffering either severely or moderately - although it's considered to be underdiagnosed. I'm a doctor and these 5 changes could be a sign of deadly lung cancer It's important to note while snoring is a common symptom of OSA, it's not a guaranteed sign. In the study, researchers at Marshall University in West Virginia tracked lung cancer diagnoses and separated those diagnosed with OSA and those without. After accounting for different influential factors, such as age, people with OSA were found to be 1.21 times more likely to develop lung cancer compared to those without the sleep disorder. Dr Jowan Al-Nusair, study co-author and physician at Marshall University told MailOnline it was "one of the first statistically significant studies" to prove a link between the condition and lung cancer. She added: "While further studies are definitely now needed to investigate just how the significant the link truly is, this suggests OSA may be a preventable risk factor for lung cancer. "We should be more closely monitoring patients with OSA. Patients would definitely benefit from screening and early intervention to combat OSA. "Additional studies are essential to understand exactly why OSA may increase this risk. "We really hope this will pave the way for future research and testing." Lung cancer is the leading cause of cancer deaths worldwide. In the UK, around 35,000 people die from lung cancer each year. The primary cause of lung cancer is tobacco smoke, accounting for the vast majority of cases. But lung cancer cases are now rising among young people who have never smoked, with some experts attributing this to factors like air pollution. Do you have obstructive sleep apnoea? Sleep apnoea is when your breathing stops and starts while you sleep. The most common type is called obstructive sleep apnoea (OSA). Sleep apnoea needs to be treated because it can lead to more serious problems. Symptoms mainly happen while you're asleep, they include: breathing stopping and starting making gasping, snorting or choking noises waking up a lot loud snoring During the day, you may also: feel very tired find it hard to concentrate have mood swings have a headache when you wake up It can be hard to tell if you have sleep apnoea. It may help to ask someone to stay with you while you sleep so they can check for the symptoms. If a GP thinks you might have sleep apnoea, they may refer you to a specialist sleep clinic for tests. Source: NHS
Indian Express
11-05-2025
- Health
- Indian Express
‘That next-day blah after drinking?': Celebrity nutritionist highlights alcohol's devastating impact on sleep
Alcohol's detrimental impact on our health is a well-established fact – backed by science and medical experts for decades now. In a recent Instagram upload, celebrated nutritionist Pooja Makhija shared how an alcohol-induced hangover messes up our sleep cycle 'That next-day blah after drinking? It's not just the alcohol — it's your brain paying for fake sleep. Alcohol sedates you, suppresses REM, and messes with your circadian rhythm — leaving you tired, moody, and craving more the next night,' she mentioned in the caption of her Instagram post. And when it comes to chronic use? Makhija shared that it raises cortisol, disrupts emotional regulation, and trains your body to depend on an external off-switch. reached out to a health expert to understand the long-term effects of alcohol abuse on sleep patterns. Deepti Khatuja, head clinical nutritionist at Fortis Memorial Research Institute, Gurgaon explained that alcohol consumption can have a detrimental impact on one's sleep. Quoting studies that have revealed numerous neurotransmitter systems and other substances to be involved in the regulation of sleep and various sleep stages, she said, 'Both acute and chronic consumption alter the activity of many of these neurotransmitters such as – serotonin, norepinephrine, GABA, Glutamate and noradrenaline- as well as affect other sleep factors. These alterations may contribute to sleep disturbances observed both in alcoholics and in people undergoing alcohol withdrawal.' She added that studies have suggested that some sleep problems observed among alcoholics may persist despite sustained abstinence and the three possible explanations can be: Although many people believe alcohol facilitates sleep, Dr Arpan Chaudhuri, consultant (internal medicine) and intensivist at Manipal Hospitals in Kolkata's Salt Lake told that alcohol use is actually shown to impair sleep quality and the amount of dream sleep a person gets. This can affect memory and concentration. Alcohol use can also make sleep apnoea worse. 'When alcohol is consumed just before bedtime, its percentage remains high in blood and that leads to instant sleep. But as the liver starts to metabolise the alcohol, it eventually disrupts sleep, especially the REM stage, and one tends to wake up soon after falling asleep owing to alcohol consumption just before bedtime. This is what is called as a fake sleep,' he further explained. 'Shorter sleep duration and more sleep interruptions may be the results of this imbalance, which lowers total sleep quality. Obstructive Sleep Apnea (OSA) also contributes to daytime sleepiness and exhaustion. People frequently use caffeine-containing products such as coffee and cigarettes to help them remain awake during the day, fueling an unhealthy cycle,' he added. DISCLAIMER: This article is based on information from the public domain and/or the experts we spoke to. Always consult your health practitioner before starting any routine.
Bahrain News Gazette
08-05-2025
- Business
- Bahrain News Gazette
Nyxoah to Release First Quarter 2025 Financial Results on May 14, 2025
Nyxoah to Release First Quarter 2025 Financial Results on May 14, 2025 Mont-Saint-Guibert, Belgium – Wednesday May 7, 2025, 10:30pm CET / 4:30pm 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 first quarter of 2025 on Wednesday, May 14, 2025. Company management will host a conference call to discuss financial results that day beginning 2:00pm CET / 8:00am ET. A webcast of the call will be accessible via the Investor Relations page of the Nyxoah website or through this link: Nyxoah's Q1 2025 Earnings Call Webcast . For those not planning to ask a question of management, the Company recommends listening via the webcast. If you plan to ask a question, please use the following link: Nyxoah's Q1 2025 Earnings Call . After registering, an email will be sent, including dial-in details and a unique conference call access code required to join the live call. To ensure you are connected prior to the beginning of the call, the Company suggests registering a minimum of 10 minutes before the start of the call. The archived webcast will be available for replay shortly after the close of the call. 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 announced positive outcomes from the DREAM IDE pivotal study. 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 FORWARD-LOOKING STATEMENTS Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company's or, as appropriate, the Company directors' or managements' current expectations regarding the Genio® system; planned and ongoing clinical studies of the Genio® system; the potential advantages of the Genio® system; Nyxoah's goals with respect to the development, regulatory pathway and potential use of the Genio® system; receipt of FDA approval; satisfactory completion of a manufacturing facilities, methods and controls review, and the anticipated timing of the foregoing; entrance to the U.S. market; and the Company's results of operations, financial condition, liquidity, performance, prospects, growth and strategies. By their nature, forward-looking statements involve a number of risks, uncertainties, assumptions and other factors that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties, assumptions and factors could adversely affect the outcome and financial effects of the plans and events described herein. Additionally, these risks and uncertainties include, but are not limited to, the risks and uncertainties set forth in the 'Risk Factors' section of the Company's Annual Report on Form 20-F for the year ended December 31, 2024, filed with the Securities and Exchange Commission ('SEC') on March 20, 2025, and subsequent reports that the Company files with the SEC. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward-looking statements contained in this press release regarding past trends or activities are not guarantees of future performance and should not be taken as a representation that such trends or activities will continue in the future. In addition, even if actual results or developments are consistent with the forward-looking statements contained in this press release, those results or developments may not be indicative of results or developments in future periods. No representations and warranties are made as to the accuracy or fairness of such forward-looking statements. As a result, the Company expressly disclaims any obligation or undertaking to release any updates or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward- looking statements are based, except if specifically required to do so by law or regulation. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person's officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release. Contacts: Nyxoah John Landry, CFO [email protected] For Media In United States FINN Partners – Alyssa Paldo [email protected] In International/Germany MC Services – Anne Hennecke [email protected] In Belgium/France Backstage Communication – Gunther De Backer [email protected] Attachment ENGLISH_Q1 Earnings Call Announcement_FINAL GlobeNewswire Distribution ID 1001095238
Bahrain News Gazette
08-04-2025
- Business
- Bahrain News Gazette
Nyxoah Provides Update on FDA Approvable Letter for Genio System
Nyxoah Provides Update on FDA Approvable Letter for Genio System Expects to meet final FDA requirements for full PMA approval in the second quarter Mont-Saint-Guibert, Belgium – April 8, 2025, 07:00am CET / 1:00am ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) ('Nyxoah' or the 'Company'), which develops breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA) through neuromodulation, today announced an update on the FDA approval process for the Genio system. On March 26, 2025, the Company announced that the U.S. Food and Drug Administration (FDA) issued an Approvable Letter regarding the Company's Pre-Market Approval (PMA) application for the Genio® system. The Approvable Letter means that Nyxoah's application for marketing the device in the United States substantially meets the requirements of the Federal Food, Drug and Cosmetic Act and the FDA's PMA implementing regulations codified at 21 C.F.R. Part 814, and the FDA will approve the application subject to satisfactory completion of a manufacturing facilities, methods and controls review. FDA has accepted all other data provided with the PMA submission, including most importantly the clinical study that demonstrates the safety and effectiveness of the Genio® system. Nyxoah is actively addressing one remaining item before FDA approval may be granted which is the validation of one process used with a component of the Genio system at its U.S. manufacturing site. The Company is confident that it will be able to successfully complete this validation in the near term. As such, Nyxoah anticipates that its application could potentially be approved in the second quarter and intends to provide an update on the review process on its first quarter 2025 earnings call to be held in May. 'We are pleased to share that the Approvable Letter from FDA confirms that we are very close to PMA approval,' commented Olivier Taelman, Nyxoah's Chief Executive Officer. 'We believe the final remaining step is completing a process validation at our U.S. manufacturing site – action taken in response to the last set of specific validation questions sent by the FDA – which we are confident we can address swiftly and successfully. We look forward to launching Genio in the U.S. upon receipt of FDA approval.' 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 announced positive outcomes from the DREAM IDE pivotal study. 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 FORWARD-LOOKING STATEMENTS Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company's or, as appropriate, the Company directors' or managements' current expectations regarding the Genio® system; planned and ongoing clinical studies of the Genio® system; the potential advantages of the Genio® system; Nyxoah's goals with respect to the development, regulatory pathway and potential use of the Genio® system; receipt of FDA approval; satisfactory completion of a manufacturing facilities, methods and controls review, and the anticipated timing of the foregoing; entrance to the U.S. market; and the Company's results of operations, financial condition, liquidity, performance, prospects, growth and strategies. By their nature, forward-looking statements involve a number of risks, uncertainties, assumptions and other factors that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties, assumptions and factors could adversely affect the outcome and financial effects of the plans and events described herein. Additionally, these risks and uncertainties include, but are not limited to, the risks and uncertainties set forth in the 'Risk Factors' section of the Company's Annual Report on Form 20-F for the year ended December 31, 2024, filed with the Securities and Exchange Commission ('SEC') on March 20, 2025, and subsequent reports that the Company files with the SEC. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities are not guarantees of future performance and should not be taken as a representation that such trends or activities will continue in the future. In addition, even if actual results or developments are consistent with the forward-looking statements contained in this press release, those results or developments may not be indicative of results or developments in future periods. No representations and warranties are made as to the accuracy or fairness of such forward-looking statements. As a result, the Company expressly disclaims any obligation or undertaking to release any updates or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based, except if specifically required to do so by law or regulation. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person's officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release. Contacts: Nyxoah John Landry, CFO [email protected] For Media In United States FINN Partners – Alyssa Paldo [email protected] In International/Germany MC Services – Anne Hennecke [email protected] In Belgium/France Backstage Communication – Gunther De Backer [email protected] Attachment ENGLISH_Update on FDA Approvable Letter_FINAL GlobeNewswire Distribution ID 1001078888
Bahrain News Gazette
26-03-2025
- Business
- Bahrain News Gazette
FDA Issues Nyxoah an Approvable Letter for its Genio® System
INSIDE INFORMATION REGULATED INFORMATION FDA Issues Nyxoah an Approvable Letter for its Genio® System Mont-Saint-Guibert, Belgium – March 26, 2025, 8:00am CET / 3:00am ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) ('Nyxoah' or the 'Company'), that develops breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA) through neuromodulation, today announced that the U.S. Food and Drug Administration (FDA) has issued an Approvable Letter regarding the Company's Pre-Market Approval (PMA) application for the Genio® system. The Approvable Letter means that Nyxoah's application for marketing the device in the United States substantially meets the requirements of the Federal Food, Drug and Cosmetic Act and the FDA's PMA implementing regulations codified at 21 C.F.R. Part 814, and the FDA will approve the application subject to satisfactory completion of a manufacturing facilities, methods and controls review. The Company will work closely with the FDA to address these requests and is committed to bringing this innovative therapy to U.S. patients. 'The FDA has reviewed our submission and determined that it substantially meets the requirements for approval: the FDA's Approvable Letter included no further questions on the clinical data or biocompatibility that support the submission,' commented Olivier Taelman, Nyxoah's Chief Executive Officer. 'We are still on the right track to make Genio available to U.S. patients suffering from OSA.' This decision does not impact Genio's CE Mark or ongoing commercial activities in Europe, where the device is approved for both Complete Concentric Collapse (CCC) and non-CCC patients. 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 announced positive outcomes from the DREAM IDE pivotal study. 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. FORWARD-LOOKING STATEMENTS Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company's or, as appropriate, the Company directors' or managements' current expectations regarding the Genio® system; planned and ongoing clinical studies of the Genio® system; the potential advantages of the Genio® system; Nyxoah's goals with respect to the development, regulatory pathway and potential use of the Genio® system; the utility of clinical data in potentially obtaining FDA approval of the Genio® system; the satisfactory completion of a manufacturing facilities, methods and controls review and receipt of FDA approval; entrance to the U.S. market; and the Company's results of operations, financial condition, liquidity, performance, prospects, growth and strategies. By their nature, forward-looking statements involve a number of risks, uncertainties, assumptions and other factors that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties, assumptions and factors could adversely affect the outcome and financial effects of the plans and events described herein. Additionally, these risks and uncertainties include, but are not limited to, the risks and uncertainties set forth in the 'Risk Factors' section of the Company's Annual Report on Form 20-F for the year ended December 31, 2024, filed with the Securities and Exchange Commission ('SEC') on March 20, 2025, and subsequent reports that the Company files with the SEC. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities are not guarantees of future performance and should not be taken as a representation that such trends or activities will continue in the future. In addition, even if actual results or developments are consistent with the forward-looking statements contained in this press release, those results or developments may not be indicative of results or developments in future periods. No representations and warranties are made as to the accuracy or fairness of such forward-looking statements. As a result, the Company expressly disclaims any obligation or undertaking to release any updates or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based, except if specifically required to do so by law or regulation. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person's officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release. Contacts: Nyxoah John Landry, CFO [email protected] For Media In United States FINN Partners – Alyssa Paldo [email protected] In International/Germany MC Services – Anne Hennecke [email protected] In Belgium/France Backstage Communication – Gunther De Backer [email protected] Attachment ENGLISH_FDA Approvable Press Release GlobeNewswire Distribution ID 1001076080
