Latest news with #Genio
Business Insider
4 days ago
- Health
- Business Insider
Nyxoah receives FDA approval for Genio system
Nyxoah (NYXH) announced that the FDA has approved the Genio system for a subset of patients with moderate to severe OSA with an Apnea-Hypopnea Index of greater than or equal to 15 and less than or equal to 65. Elevate Your Investing Strategy: Take advantage of TipRanks Premium at 50% off! Unlock powerful investing tools, advanced data, and expert analyst insights to help you invest with confidence. Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>>
Irish Independent
6 days ago
- Health
- Irish Independent
‘We are seeing more people, from more backgrounds' – treatment centre says residential addiction services are at capacity
Coolmine Therapeutic Community, a drug and alcohol treatment centre in Dublin, said its residential programme for mothers with young children in Ashleigh House, along with its men's residential service at Coolmine Lodge, are full. Community services in Dublin are also nearing total occupancy after a 15.6pc increase in client presentations this year. Coolmine CEO Pauline McKeown said: 'The sustained pressure on our residential and outreach services shows the scale of need we are responding to every day. We are seeing more people, from more backgrounds, reaching out for support.' The charity said 414 people had been supported via an Assertive Traveller Outreach initiative, a Private Emergency Accommodations Team and Genio programmes – schemes funded by the Government and philanthropists – in the first half of the year. Ms McKeown said a significant part of the demand was linked to emergency accommodation, mirroring wider trends reported by homeless support organisations. In its National Addiction Trends report for the first half of this year, Coolmine found alcohol continues to be the leading substance for which people seek treatment, accounting for 40pc of presentations this year. There was a 3pc rise in presentations for alcohol addiction. Cocaine is the second-biggest issue for people, with addiction to the drug accounting for 31pc of presentations this year. Heroin accounted for 8pc, cannabis 11pc and benzodiazepines 9pc. Demand for our services, especially for women and families, remains incredibly high Regional trends indicate differences in presentations. Alcohol is the most common reason for treatment in the south-west (53pc) and mid-west (34pc), but cocaine remains the leading substance in the east (36pc). 'This report provides an important insight into the addiction challenges across the country,' Ms McKeown said. 'Alcohol and cocaine remain the most prominent substances for which people are seeking help, and demand for our services – especially for women and families – remains incredibly high. 'Our teams continue to meet this need with compassion and professionalism.' A total of 1,969 clients accessed treatment and support through Coolmine in the first half of the year. The charity said this suggests elevated service levels have become the new norm. Nationally, 57pc of clients were male and 43pc female, reflecting an increase in female engagement compared with last year. A total of 305 families have been supported this year. Thirty-seven parents participated in the Parents under Pressure programme, and 35 children currently live with a parent in treatment.
Time of India
25-06-2025
- Business
- Time of India
New report finds 70% of US college students now working while studying
Genio report reveals 7 in 10 US college students now working while enrolled. (AI Image) A newly released study reveals that the majority of college students in the US are balancing both academics and employment, reshaping the traditional image of a full-time student. According to The New Majority Learner Report 2025 , published by Genio , 69.3% of college students are now holding jobs while pursuing their studies—an increase of 10 percentage points since 2016. The report, based on data from the Integrated Postsecondary Education Data System and the National Postsecondary Student Aid Study, highlights a growing trend: today's students are not the stereotypical recent high school graduates attending college full-time. Instead, they are older, often financially independent, and juggling multiple responsibilities. Nontraditional students now make up the new majority Genio's report identifies this growing population as "new majority learners," a term referring to students who defy traditional college norms. These individuals now constitute a majority of the US college population. Among the key findings: Student Characteristic Percentage (%) Students over age 22 40.20% Students working while studying 69.30% Students enrolled part-time 39.10% Students who are parents 19.20% First-generation college students 30.00% Immigrant students 25.00% Students needing ESL support 17.70% Neurodivergent students 16.50% These figures underscore the reality that today's "typical" student is far from typical. Many are described as "time poor," managing work, education, and family responsibilities simultaneously. Academic preparedness and diverse needs are pressing concerns The report also draws attention to the academic challenges faced by this population. Many are underprepared for college-level work, particularly first-generation students, veterans, immigrants, and those from underrepresented communities. In addition, 16.5% of students are neurodivergent, a figure that has grown more than 2.5 times since 2004. This includes individuals with ADHD, autism spectrum disorders, and other learning differences. Dave Tucker, founder and CEO of Genio, emphasized the urgency of addressing these needs, stating that colleges are "facing a crisis of revenue" as enrollment patterns shift. He told Forbes that improving support for new majority learners is essential for student retention and institutional survival. A call for targeted support and systemic change To support this evolving demographic, the report outlines five key strategies institutions should adopt: • Introduce study skills courses tailored to new majority learners • Use assistive technologies to improve academic outcomes • Expand flexible and accessible online learning options • Implement early warning systems to identify at-risk students• Develop targeted programs for first-generation students, including advising, financial aid, and campus resources The report stresses the importance of building a "network of support" that offers community and guidance, as reported by Forbes. Without these changes, colleges risk losing not only revenue but also the chance to help a growing segment of the student population succeed. Is your child ready for the careers of tomorrow? Enroll now and take advantage of our early bird offer! Spaces are limited.
Forbes
25-06-2025
- Business
- Forbes
Nontraditional Students Are The New College Majority, Report Finds
More than 40% of higher education students are older than 22, and almost 70% are holding down jobs ... More while taking courses, finds a new report on the "new majority" college student. Nontraditional students now constitute what a just-released report is calling the 'new majority" of higher education learners in the United States. Titled The New Majority Learner Report 2025, the study was prepared by Genio, a provider of its popular Genio Notes and other education support tools and technology geared toward helping students deal with different kinds of learning challenges. Using data from the Integrated Postsecondary Education Data System and the National Postsecondary Student Aid Study, the study describes the multiple, intersecting characteristics of non-traditional students, who now, it claims, comprise an ever-increasing percentage of the student body in higher education. It also explores the special needs and unique learning challenges faced by this group. According to the report, the 'typical' college student is not enrolled full-time and is not a recent high school graduate. Instead, the following three characteristics capture the changing picture of today's college students. First, they are often what the report terms 'time poor," requiring them to multi-task in several areas of their lives, including taking courses while they are working and forcing them to juggle family responsibilities, career demands, and financial challenges while studying. Second, they tend to be academically underprepared for college-level work. Included in this group are first-generation college students, international learners who are new to America's higher education culture, veterans, and individuals from underrepresented communities. And third, many face individual barriers such as being physically disabled, neurodiverse or needing to learn English as a second language. More specifically the report found that: The report also recommends five strategies that colleges and universities can use to help support these traditionally underserved students, including: These interventions can be expensive so adequate funding is a challenge, but the consequences of not catering to the special needs of the increasing number of new majority students can result in even greater costs to institutions both in terms of reduced revenue but also in lost opportunities for educational success by a greater proportion of students. 'Especially as higher education faces the coming enrollment cliff and, in the U.S., uncertainty regarding international students, institutions are facing a crisis of revenue,' said Dave Tucker, founder and CEO at Genio in a press release. 'They need to find ways to retain more students, which means improving support for their new majority learners,' Tucker added.
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
