SOPHIA ANTIPOLIS, France--(BUSINESS WIRE)--
Regulatory News:
Median Technologies (FR0011049824, ALMDT, PEA/SME eligible, “Median” or “The Company”), a leading developer of eyonis™, a suite of artificial intelligence (AI) powered Software as a Medical Device (SaMD) for early cancer diagnostics, and a globally leading provider of AI-powered imaging analyses and central imaging services for oncology drug developers, today announced that it will attend the European Congress of Radiology (ECR) 2025 in Vienna, from Feb. 26 to March 2.
The Median eyonis™ team will welcome interested parties at Booth #AI-18, AI Exhibition, Expo X1, from February 26 to March 1 (technical exhibits dates). The Company will share the latest developments for eyonis™ Lung Cancer Screening (LCS) Software as a Medical Device (SaMD).
The Company recently that eyonis™ LCS, its AI-powered SaMD for Lung Cancer Screening met the primary endpoint with statistical significance in RELIVE, the second of two successful pivotal studies required for marketing authorizations in US and Europe (ClinicalTrials.gov identifier ). RELIVE secondary endpoints results will be communicated as soon as all the statistical analyses are finalized.
The protocol and primary endpoints for the two pivotal studies, RELIVE and REALITY, were defined in accordance with discussions held with the FDA. By achieving the primary endpoints in both pivotal studies, eyonis™ LCS has successfully completed the regulatory requirements for clinical validation. Consequently, the regulatory dossiers for obtaining the U.S. 510(k) and European CE marking of eyonis™ LCS will be submitted to the agencies in the second quarter of this year.
“The recently reported pivotal study results suggest eyonis™ LCS may enable broad implementation of LDCT lung cancer screening procedures by improving lung cancer diagnosis accuracy and addressing the bottlenecks of complexity and time required for analyzing LDCT images,” said Thomas Bonnefont, COO and CCO of the eyonis™ Business Unit at Median Technologies. “Based on our strong pivotal results, we are now looking towards our filings for marketing authorizations, in both the US and Europe, in Q2 2025, as soon as we finish the analysis. We will report RELIVE secondary endpoints results in the coming weeks. In the interim, we are very pleased to share the eyonis™ LCS pivotal study results already available, and discuss the game changing potential of our Software as a Medical Device with the radiology community at the European Congress of Radiology”, Thomas Bonnefont added.
Median’s eyonis™ team will present at ECR:
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Industry Presentation:
Presenter: Valérie Bourdès, MD, VP Clinical and Medical Affairs, eyonis™ - Median Technologies
Session AI-IND 3 - AI Lightning Talks 3
Wednesday, February 26 - 13:30 – 14:30 CET
AI Theatre, ACV Building Level -2
Concurrently, Median’s iCRO team will present:
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Research Presentation :
Author: Hubert Beaumont, Lead Scientist, Median Technologies
Research Presentation Session: Oncologic Imaging
Session: RPS 116 - Staging, metastases and response assessment
Wednesday, February 26 – 8:00 – 9:30 CET
ACV Building, Research Stage 3
About eyonis™ LCS: eyonis™ Lung Cancer Screening (LCS) is an AI/ML-enabled Software as a Medical Device that uses machine learning to analyze imaging data generated with low dose computed tomography (LDCT). eyonis™ LCS aids to diagnose 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 (successfully completed - ) and RELIVE (primary endpoint successfully achieved, secondary endpoints analysis on-going - ). Filing applications including these pivotal data are scheduled to be submitted for FDA 510(k) clearance and CE marking in Q2 2025.
About Median Technologies: Pioneering innovative imaging solutions and Software as a Medical Device, 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 medical devices (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.
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