- Projected economic benefits of using AI-powered detection/diagnostic Software as a Medical Device, like eyonis® LCS, will be presented at ISPOR 2025, the annual conference of the leading professional society for health economics and outcomes research
- Positive eyonis® LCS’ REALITY pivotal data to be presented at American Thoracic Society (ATS) 2025 International Conference
- The eyonis® team will be hosting interested parties at booth #1662 during ATS 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 (Clinicaltrials.gov ID: NCT06576232) and RELIVE (Clinicaltrials.gov 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 www.mediantechnologies.com.
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.
Contacts
MEDIAN TECHNOLOGIES
Emmanuelle Leygues
VP, Corporate Marketing & Financial Communications
+33 6 10 93 58 88
[email protected]
Investors – SEITOSEI ACTIFIN
Ghislaine Gasparetto
+33 6 21 10 49 24
[email protected]
U.S. media & investors – COHESION BUREAU
Chris Maggos
+41 79 367 6254
chris.maggos@cohesionbureau.com
Press – ULYSSE COMMUNICATION
Bruno Arabian
+33 6 87 88 47 26
[email protected]
Nicolas Entz
+33 6 33 67 31 54
[email protected]
