Median Technologies has secured €47.5m to support regulatory filings and commercialisation activities of lung cancer diagnostic technology, eyonis.
France-based Median Technologies has agreed to a €37.5m loan from the European Investment Bank (EIB) and forged an equity line for up to €10m with IRIS Capital Investment.
The funding will support eyonis Lung Cancer Screening (LCS) Software as a Medical Device (SaMD) US Food and Drug Administration (FDA) regulatory approval, CE marking, and ongoing commercialisation partnerships discussions with US-based AI diagnostic providers.
eyonis LCS is an AI-powered diagnostic device that utilises machine learning to analyse low-dose CT imaging data for early lung cancer detection.
By identifying cancer at its earliest, treatable stages, eyonis LCS aims to improve patient outcomes. It was also showcased at the Radiological Society of North America (RSNA) 2024 in November.
Classified as Software as a Medical Device (SaMD), it is undergoing REALITY (completed) and RELIVE (ongoing) studies, both crucial for US and European market approvals.
Applications for FDA 510(k) clearance and CE marking are set for Q2 2025. Marketing authorisations are expected in Q3 2025 for the US and Q1 2026 for the European Economic Area (EEA), assuming normal review times.
Additionally, Median’s AI technology is being sold and used in clinical trials across various cancer indications.
The medical technology firm supports these pharmaceutical companies through its iCRO business unit, which provides medical image analysis and management services in oncology trials.
Median Technologies CEO and founder Fredrik Brag said: “We are confident that eyonis LCS will offer medical professionals increased efficiency and accuracy so that they can scale up the currently painstaking lung cancer diagnostic process.
“We believe more patients will cure their cancer through early detection thanks to eyonis LCS SaMD; in turn, early detection will reduce the overall costs of treating uncurable later stage lung cancer.
“The future of eyonis AI diagnostics represents a win for patients, doctors, payers and our shareholders.”
Median Technologies, which trades on the Euronext Growth market, has also announced its plans to release eyonis LCS RELIVE study data in Q1 2025.
RELIVE, a Multi-Reader Multi-Case trial, aims to validate eyonis LCS’s ability to assist radiologists in diagnosing lung cancer, complementing REALITY’s successful analytical validation.
