Median Technologies Reports 2023 Revenue and Summarizes 2024 Strategic Outlook

Regulatory News:

Median Technologies (FR0011049824, ALMDT, PEA/SME eligible) announces its 2023 revenue, outlining both its strategic outlook and key milestones for 2024.

Fredrik Brag, Chief Executive Officer and Founder of Median Technologies, commented: "In Q4 2023, our iCRO¹ business achieved record-high order intake, which increased significantly our backlog. The order backlog² is at an all-time high of €66.9m. Today more than ever, the pharmaceutical industry is investing massively in Artificial Intelligence (AI), specifically in the field of oncology clinical trials, and our differentiated Imaging Lab solution enables us to win business with Big Pharma groups, partner with global CROs and widen the scope of indications that our services address. We expect to return to growth in 2024 on the back of a decline in 2023 revenue due to soft order intake in China caused by the Covid lockdowns in 2022 and H1 2023."

Fredrik Brag added: “Execution of the pivotal studies for eyonis LCS is on track following the excellent results from the independent verification study announced in January 2024. Studies part of the FDA 510(k) clearance and CE marking process were launched in July last year, all patients have been recruited, the independent verification is already finalized and the Standalone and MRMC studies are underway. The Standalone study will be finalized in Q2 2024 and the MRMC study in Q3 2024. We are targeting FDA 510(k) clearance for the CADe/CADx Software as Medical Device eyonis LCS in Q1 2025, followed by the launch for the US lung cancer screening market, which covers 14.5 million people with an existing reimbursement per procedure of $650. Regarding Europe, we expect to obtain CE marking in Q2 2025. Lung cancer is the number one cause of mortality by cancer worldwide. Early diagnosis has been proven to save patients’ lives. Our AI-powered imaging solutions will deliver major progress in the early diagnosis of lung cancer."

Jean-Christophe Montigny, Chief Financial Officer of Median Technologies commented: "With our successful refinancing which took place in July 2023, plus the €8.5m drawdown at the start of 2024 for the final tranche of the loan granted by the European Investment Bank (EIB), we expect Company’s operations to be fully financed until Q2 2025".

eyonis: AI-driven patient care innovation

Excellent results from eyonis LCS independent verification study

In July 2023, the Company announced the initiation of all US and European sites involved in the pivotal eyonis LCS (Lung Cancer Screening) studies, the results of which will be the subject of regulatory filings for FDA 510(k) and CE marking. All patients have been recruited, the independent verification is already finalized and the Standalone and MRMC studies are underway.