Latest news with #PEA-PME
Yahoo
27-05-2025
- Business
- Yahoo
Median Technologies to Showcase iCRO's Central and AI-Powered Imaging Services for Oncology Clinical Trials at ASCO 2025
Median is a leading provider of imaging services to the world's top oncology pharma companies ASCO abstracts position Median as highly differentiated provider of AI-imaging services for oncology trials Median will host two presentation sessions to introduce its new solution for radiopharmaceutical image processing for oncology research at booth #11046 SOPHIA ANTIPOLIS, France, May 27, 2025--(BUSINESS WIRE)--Regulatory News: Median Technologies (FR0011049824, ALMDT, PEA-PME scheme eligible, "Median" or the "Company"), manufacturer of eyonis®, a suite of artificial intelligence (AI) powered Software as a Medical Device (SaMD) for early cancer diagnosis, and a globally leading provider of AI-based image analyses and central imaging services for oncology drug developers, announced today that the Company will be participating in the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting taking place from May 30 to June 2, McCormick Place, Chicago, IL, USA. Median's team will be hosting interested parties at booth #11046, South Building, Hall A, McCormick Place, from May 31 to June 2 (exhibit dates), from 9:00 am to 5:00 pm CT, where it will share the most recent advances for its central and AI-powered imaging services for oncology clinical trials. Median Technologies' abstracts selected for online publication are available on the ASCO platform: Abstract e24073: Technical Performance of the L3 Skeletal Muscle Index in CT Abstract e13590: Using tumor growth modeling and informed neural networks as early predictive clinical endpoints Median will host two 30-minute presentation sessions on how the Company's new solution for radiopharmaceutical image processing is advancing oncology research. Sessions will take place at booth #11046 on Saturday, May 31 and Sunday, June 1, 11:30 am -12:00 pm CT. The ASCO Annual Meeting is the world's premier oncology conference, organized by the American Society of Clinical Oncology, the largest oncology society in the world. Each year, the ASCO conference brings together more than 35,000 oncologists from all around the globe, and is attended by all medical, educational and industrial stakeholders involved in the field of oncology worldwide. More about the ASCO Annual Meeting: About Median Technologies: Pioneering innovative software as a medical device and imaging services, Median Technologies harnesses cutting-edge AI to enhance the accuracy of early cancer diagnoses and treatments. Median's offerings include iCRO, which provides medical image analysis and management in oncology trials, and eyonis®, an AI/ML tech-based suite of software as a medical device (SaMD). Median empowers biopharmaceutical entities and clinicians to advance patient care and expedite the development of novel therapies. The French-based company, with a presence in the U.S. and China, trades on the Euronext Growth market (ISIN: FR0011049824, ticker: ALMDT). Median is also eligible for the French SME equity savings plan scheme (PEA-PME). For more information, visit View source version on Contacts MEDIAN TECHNOLOGIES Emmanuelle LeyguesVP, Corporate Marketing & Financial Communications+33 6 10 93 58 Investors - SEITOSEI ACTIFIN Ghislaine Gasparetto+33 6 21 10 49 U.S. media & investors - COHESION BUREAU Chris Maggos+41 79 367 Press – ULYSSE COMMUNICATION Bruno Arabian+33 6 87 88 47 26barabian@ Nicolas Entz+33 6 33 67 31 54nentz@ Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Wire
22-05-2025
- Business
- Business Wire
ADOCIA Confirms its Eligibility for the PEA‑PME Scheme
LYON, France--(BUSINESS WIRE)--Regulatory News: Adocia (Euronext Paris: FR0011184241 – ADOC), a clinical-stage biopharmaceutical company focused on the research and development of innovative therapeutic solutions for the treatment of diabetes and obesity, confirms that it meets the eligibility criteria for its shares to be held in a PEA-PME account, set forth in Article L.221-32-2 of the French Monetary and Financial Code. Consequently, investment in Adocia shares can be made through PEA-PME savings accounts. This scheme is specially designed to encourage investment in small and medium-sized companies, offering tax benefits notably an income tax exemption on gains realized, provided no withdrawals are made during the first 5 years. About Adocia Adocia is a biotechnology company specializing in the discovery and development of therapeutic solutions in the field of metabolic diseases, primarily diabetes and obesity. The company has a broad portfolio of drug candidates based on four proprietary technology platforms: 1) The BioChaperone ® technology for the development of new generation insulins and products combining different hormones; 2) AdOral ®, an oral peptide delivery technology; 3) AdoShell ®, an immunoprotective biomaterial for cell transplantation, with an initial application in pancreatic cells transplantation; and 4) AdoGel ®, a long-acting drug delivery platform. Adocia holds more than 25 patent families. Based in Lyon, the company has about 80 employees. Adocia is listed on the regulated market of Euronext ™ Paris (Euronext: ADOC; ISIN: FR0011184241). Disclaimer This press release contains certain forward-looking statements concerning Adocia and its business. Such forward-looking statements are based on assumptions that Adocia considers as being reasonable. However, there can be no guarantee that the estimates contained in such forward-looking statements will be achieved, as such estimates are subject to numerous risks including those set forth in the 'Risk Factors' section of the universal registration document that was filed with the French Autorité des marchés financiers on April 29, 2025, available at Those risks include uncertainties inherent in Adocia's short- or medium-term working capital requirements, in research and development, future clinical data, analyses and the evolution of economic conditions, the financial markets and the markets in which Adocia operates, which could impact the Company's short-term financing requirements and its ability to raise additional funds. The forward-looking statements contained in this press release are also subject to risks not yet known to Adocia or not considered as material by Adocia at this time. The occurrence of all or part of such risks could cause the actual results, financial conditions, performances, or achievements of Adocia be materially different from those mentioned in the forward-looking statements.
Business Wire
14-05-2025
- Business
- Business Wire
Median Technologies submits U.S. application for 510(k) clearance of eyonis ® LCS
SOPHIA ANTIPOLIS, France--(BUSINESS WIRE)--Regulatory News: Median Technologies (FR0011049824, ALMDT, PEA-PME scheme eligible, 'Median' or the 'Company'), manufacturer of eyonis ®, a suite of artificial intelligence (AI) powered Software as a Medical Device (SaMD) for early cancer diagnosis, and a globally leading provider of AI-based image analyses and central imaging services for oncology drug developers, today announced it has filed an application to the U.S. Food and Drug Administration (FDA) for 510(k) clearance of eyonis ® LCS, its AI/ML tech-based SaMD for computer aided detection and diagnosis (CADe/CADx) in lung cancer screening. The submission is based on positive data from the two pivotal studies of eyonis ® LCS, REALITY and RELIVE, both of which met their primary endpoints. This data demonstrated that eyonis ® LCS provides robust diagnostic performance for early detection and characterization of lung nodules in high-risk lung cancer populations, with significant potential to impact patients' clinical outcomes. Additionally, Median's eyonis ® LCS SaMD confirmed safety and efficacy in RELIVE, the second and last pivotal study. ' eyonis ® LCS' FDA filing is a major milestone for Median and a testament to our R&D and clinical programs' strength, ' said Fredrik Brag, CEO and Founder of Median Technologies. 'RELIVE and REALITY pivotal studies met their primary endpoints and confirmed the device's safety and efficacy. This shows that eyonis ® LCS has the potential to be a game-changer in lung cancer screening. By providing early detection and characterization at scale, eyonis ® LCS can significantly improve high-risk patient outcomes. Based on average observed review regulatory timeframes, we would expect an eyonis ® LCS' clearance in the U.S. in Q3 this year.' Results from REALITY released in August 2024, showed that eyonis ® LCS can accurately detect and characterize lung nodules, with exceptional results of an area under the curve (AUC) value of 0.904 versus the minimum value set as a primary endpoint for REALITY of an AUC of 0.80. Results from RELIVE released in March 2025, showed that radiologists aided by eyonis ® LCS achieved statistically significant improved performance over radiologists alone (p=0.027) and can thus improve clinicians' diagnostic accuracy in analyzing low dose computed tomography (LDCT) lung cancer screening scans. In addition, importantly, the Company believes that eyonis ® LCS can increase efficiency of LDCT scans analyses, so that healthcare professionals can process many more patients through lung cancer screening with greater confidence in diagnostic accuracy. Lung cancer screening is recommended by the U.S. Preventive Services Task Force (USPSTF) in adults aged 50 to 80 years who have a 20 pack-year smoking history. The market opportunity includes a population of 14.5 million people in the U.S. alone, currently eligible for a lung cancer screening exam, with an existing potential reimbursement of $650 per exam with a SaMD postprocessing for characterization of malignant vs benign nodules. This represents a total addressable annual market of over $10bn. The eligible U.S. patient number is expected to rise in the coming years, driven by planned broadening of the eligibility criteria. Similarly, new lung screening program deployments are planned in Europe and Asia. In the US alone, the direct medical costs of cancer patients care were estimated to be nearly $230 billion in 2023 1. The vast majority of cancer care costs are incurred in treating advanced cancer patients, versus preventive care such as screening that save patients' lives. About eyonis™ LCS: eyonis ® Lung Cancer Screening (LCS) is an artificial intelligence AI-based computer aided detection and diagnosis (CADe/CADx) Software as a Medical Device (SaMD) that uses machine learning to help analyze imaging data generated with low dose computed tomography (LDCT) to aid radiologists in diagnosis of lung cancer at the earliest stages, when it can still be cured in many patients. eyonis ® LCS is the subject of two pivotal studies required for marketing approvals in the U.S. and Europe: REALITY ( ID: NCT06576232) and RELIVE ( ID: NCT06751576), both of which have been successfully completed. About Median Technologies: Pioneering innovative software as a medical device and imaging services, Median Technologies harnesses cutting-edge AI to enhance the accuracy of early cancer diagnoses and treatments. Median's offerings include iCRO, which provides medical image analysis and management in oncology trials, and eyonis™, an AI/ML tech-based suite of software as a medical device (SaMD). Median empowers biopharmaceutical entities and clinicians to advance patient care and expedite the development of novel therapies. The French-based company, with a presence in the U.S. and China, trades on the Euronext Growth market (ISIN: FR0011049824, ticker: ALMDT). Median is also eligible for the French SME equity savings plan scheme (PEA-PME). For more information, visit Forward-Looking Statements This press release contains forward-looking statements. These statements are not historical facts. They include projections and estimates, as well as the assumptions on which these are based, statements concerning projects, objectives, intentions, and expectations with respect to future financial results, events, operations, services, product development and potential, or future performance. These forward-looking statements can often be identified by the words "expects," "anticipates," "believes," "intends," "estimates" or "plans" and any other similar expressions. Although Median's management believes that these forward-looking statements are reasonable, investors are cautioned that forward-looking statements are subject to numerous risks and uncertainties, many of which are difficult to predict and generally beyond the control of Median Technologies, that could cause actual results and events to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. All forward-looking statements in this press release are based on information available to Median Technologies as of the date of the press release. Median Technologies does not undertake to update any forward-looking information or statements, subject to applicable regulations, in particular Articles 223-1 et seq. of the General Regulation of the French Autorité des Marchés Financiers. 1 American Cancer Society.
Business Wire
12-05-2025
- Business
- Business Wire
Median Technologies to Present Scientific Posters on eyonis® LCS in Two Major Health Conferences in North America in May 2025
SOPHIA ANTIPOLIS, France--(BUSINESS WIRE)--Regulatory News: Median Technologies (FR0011049824, ALMDT, PEA-PME scheme eligible, 'Median' or the 'Company'), manufacturer of eyonis®, a suite of artificial intelligence (AI) powered Software as a Medical Device (SaMD) for early cancer diagnosis, and a globally leading provider of AI-based image analyses and central imaging services for oncology drug developers, announced today that the Company will attend two major health conferences and present posters on its Software as a Medical Device (SaMD) eyonis® LCS, for Lung Cancer Screening. The eyonis® LCS SaMD is an AI-powered Software as a Medical Device (SaMD) to detect and diagnose (CADe/CADx) lung cancer in Low Dose Computed Tomography (LDCT) images. eyonis® LCS has met the primary endpoints in the two pivotal clinical trials required for FDA and CE marking regulatory submissions. The FDA 510K application for eyonis® LCS U.S. marketing authorization is scheduled for submission shortly and clearance and commercialization are expected late this year. Median will present its findings on the projected U.S. economic benefit that eyonis® LCS can offer payers at ISPOR 2025, the leading conference for health economics and outcomes research, taking place in Montreal, QC, Canada, May 13-16, 2025. Based on a Markov health economic model simulating lung cancer progression over five years, the analysis, grounded in the respective performance of radiologists and AI, demonstrates that eyonis® LCS enhances early detection and characterization, reduces unnecessary procedures, and generates significant cost savings for U.S. payers. These findings support integrating eyonis® LCS into routine lung cancer screening programs. Separately, at the American Thoracic Society (ATS) International Conference, in San Francisco, CA, USA, from May 17-21, 2025, Median will present positive data from the pivotal trial REALITY showing that eyonis® LCS optimized detection, localization, characterization and management of small screening-detected nodules, leading to earlier diagnoses, more effective treatment and positively impacting survival of lung cancer patients. In addition, the Median eyonis® team will welcome interested parties during ATS 2025 at Booth #1662. The Company will share the latest developments for eyonis® LCS SaMD. Presentation at the ISPOR 2025 Conference - Montreal, QC, Canada, May 13-16, 2025 Poster #OP9: Budget Impact Model of Enhanced Lung Cancer Screening with AI/ML Tech-Based Software as a Medical Device (SaMD) on a US Cohort and Private Payer Perspective Poster Session 5 Topic: Organizational Practices Friday May 16, 2025, 9:00 am - 11:30 am EDT Poster discussion slot from 9:00 to 10:00 am EDT Main Poster Area First author & presenter: Antoine Disset, PhD, VP Market Access and Gov. Affairs eyonis®, Median Technologies Presentation at the American Thoracic Society (ATS) 2025 International Conference – San Francisco, CA, USA – May 17-21, 2025. Poster #13190: AI-Assisted Lung Cancer Screening: Results from REALITY, a Pivotal Validation Study of an AI/ML-Based Software Poster Session: B110 - The road to Early Detection: Advancing Lung Cancer Screening through AI, Risk Models, and Real-World Data Topic: Lung Cancer, Thoracic Oncology Poster discussion: Monday May 19, 2025, 2:15 pm - 4:15 pm PDT Main Poster Area – Poster Board #616 About eyonis® LCS: eyonis® Lung Cancer Screening (LCS) is an artificial intelligence AI/ML-based computer aided detection and diagnosis (CADe/CADx) system, or Software as a Medical Device (SaMD) that uses machine learning to help analyze imaging data generated with low dose computed tomography (LDCT) to aid radiologists in diagnosis of lung cancer at the earliest stages, when it can still be cured in many patients. eyonis® LCS is the subject of two pivotal studies required for marketing approvals in the U.S. and Europe: REALITY ( ID: NCT06576232) and RELIVE ( ID: NCT06751576), both of which have been successfully completed. Regulatory filings including this pivotal data are scheduled to be submitted for FDA 510(k) clearance and CE marking in May and June 2025 respectively. About Median Technologies: Pioneering innovative software as a medical device and imaging services, Median Technologies harnesses cutting-edge AI to enhance the accuracy of early cancer diagnoses and treatments. Median's offerings include iCRO, which provides medical image analysis and management in oncology trials, and eyonis®, an AI/ML tech-based suite of software as a medical device (SaMD). Median empowers biopharmaceutical entities and clinicians to advance patient care and expedite the development of novel therapies. The French-based company, with a presence in the U.S. and China, trades on the Euronext Growth market (ISIN: FR0011049824, ticker: ALMDT). Median is also eligible for the French SME equity savings plan scheme (PEA-PME). For more information, visit Forward-Looking Statements This press release contains forward-looking statements. These statements are not historical facts. They include projections and estimates, as well as the assumptions on which these are based, statements concerning projects, objectives, intentions, and expectations with respect to future financial results, events, operations, services, product development and potential, or future performance. These forward-looking statements can often be identified by the words "expects," "anticipates," "believes," "intends," "estimates" or "plans" and any other similar expressions. Although Median's management believes that these forward-looking statements are reasonable, investors are cautioned that forward-looking statements are subject to numerous risks and uncertainties, many of which are difficult to predict and generally beyond the control of Median Technologies, that could cause actual results and events to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. All forward-looking statements in this press release are based on information available to Median Technologies as of the date of the press release. Median Technologies does not undertake to update any forward-looking information or statements, subject to applicable regulations, in particular Articles 223-1 et seq. of the General Regulation of the French Autorité des Marchés Financiers.
Yahoo
07-05-2025
- Business
- Yahoo
HighCo: Shareholding as 04
HIGHCO INFORMATION CONCERNING THE TOTAL NUMBER OF VOTING RIGHTS AND SHARES Declaration pursuant to Articles L.233-8 II of the French Commercial Code and 223-16 of the General Regulations of the Autorité des marchés financiers (AMF) Date of settlement of information Total number of shares Number of shares without voting rights (*) Number of voting rights for threshold calculation (**) Number of actual voting rights (exercisable at shareholders' meeting) April 30, 2025 20 455 403 810 840 22 284 457 21 473 617 March 31, 2025 20 455 403 809 380 22 282 875 21 473 495 February 28, 2025 20 455 403 812 886 22 282 791 21 469 905 January 31, 2025 20 455 403 818 981 22 282 977 21 463 996 December 31, 2024 20 455 403 817 845 22 282 774 21 464 929 (*) exclusively consisting of treasury shares. (**) theoretical voting rights to calculate the threshold crossing including the voting right of treasury shares (article 223-11 of the General Regulations AMF). About HighCo As an expert in marketing and communication, HighCo supports brands and retailers in accelerating the transformation of retail. Listed in compartment C of Euronext Paris, and eligible for SME equity savings plans ('PEA-PME'), HighCo has nearly 450 employees. HighCo has achieved a Gold rating from EcoVadis, meaning that the Group is ranked in the top 5% of companies in terms of CSR performance and responsible purchasing. Your contacts Cécile COLLINA-HUE Nicolas CASSAR Managing Director Press Relations +33 1 77 75 65 06 +33 4 88 71 35 46 comfi@ Upcoming event Publication take place after market close . Quarterly Gross Profit Q2 and H1 2025 Gross Profit: Tuesday, 22 July 2025 Q3 and 9-months 2025 Gross Profit: Wednesday, 15 October 2025 2025 Gross Profit: Wednesday, 28 January 2026
