Median Technologies has successfully completed a €61.4 million refinancing operation and extended its operational runway through at least Q4 2026, positioning the French AI medical device company to advance its lung cancer screening technology toward market authorization in both the United States and Europe.
The financing, completed in two phases during July and August 2025, includes a €23.9 million capital increase through ordinary shares with warrants and a €37.5 million financing facility from the European Investment Bank. The company's cash position could extend well beyond 2026 if all 14,424,541 share warrants are exercised, potentially generating an additional €51.7 million.
"Thanks to the financial visibility gained from our recent successful financing, we are fully equipped to deliver on our growth strategy with our cash runway now extending until at least Q4 2026, and potentially much further," said Fredrik Brag, CEO and Founder of Median Technologies.
FDA Review Timeline Extended for eyonis® LCS
Median Technologies' flagship AI-powered Software as a Medical Device, eyonis® LCS, continues its regulatory journey toward FDA 510(k) clearance for lung cancer screening applications. The company submitted its market authorization application to the FDA in May 2025 and received a request for additional information on July 12, 2025.
Due to decreased FDA staffing levels, the regulatory review period has been extended, with the company now expecting a final decision in early Q1 2026. This timeline aligns with similar delays affecting other biopharmaceutical and medical technology companies seeking market authorization.
"Recent changes within the FDA are driving a longer review period for our submission -- in line with delays currently being observed across the biopharmaceutical and medtech industries," Brag explained.
Commercial Launch Preparations Advance
In preparation for market entry, Median Technologies has completed comprehensive mapping of all medical institutions involved in lung cancer screening in the United States. The company has developed a multi-phase, regionally tailored commercial strategy with precise segmentation of key accounts and created all necessary sales aids and training tools.
Negotiations with potential commercial partners for the U.S. market launch are progressing and are expected to culminate in agreements parallel with market authorization. The company has also expanded its network of key opinion leaders in radiology, pulmonology, and thoracic oncology through site visits and engagement with medical societies.
During the World Conference on Lung Cancer held in Barcelona from September 6-9, 2025, Median met with the international lung cancer screening medical community, increasing visibility for eyonis® LCS among future users and advancing discussions about health-economic studies planned for post-authorization launch.
European Market Opportunities
The regulatory review process for CE marking in Europe is also progressing, with the company having submitted its application in June 2025. The European market presents significant opportunities, with an estimated target population of 20 million people for lung cancer screening.
Several European countries have already implemented or are planning national screening programs based on low-dose computed tomography. Croatia, Poland, and the Czech Republic currently operate national screening programs, while Germany is scheduled to launch its program in April 2026. France has initiated promising pilot programs.
iCRO Division Gains Momentum
Median's iCRO division, which provides AI-based image analysis and central imaging services for oncology drug developers, has demonstrated strong growth momentum. The division's strategy to target major pharmaceutical groups and global contract research organizations has yielded a 30% increase in the cumulative value of requests for proposals over the first nine months of 2025.
The company's Chinese subsidiary secured €3.4 million in new orders from one of the top three pharmaceutical companies in China, with Median now managing half of the newly launched oncology clinical trials for this pharmaceutical group. According to IQVIA Institute data, China-based companies initiated 39% of all global new oncology trials in 2024, surpassing U.S. companies (32%) and European companies (20%).
To address evolving market needs, the iCRO division has launched specialized imaging services for radiopharmaceutical therapy clinical trials, a rapidly growing segment in oncology drug development. This differentiated offering is generating strong market traction and contributing to the expansion of the company's order backlog.
Strategic Positioning
Following a preferred supplier agreement with a second top-three global oncology pharmaceutical company announced in May 2024, Median is in advanced discussions with other top-10 global pharmaceutical groups for additional preferred supplier agreements.
The company's dual focus on regulatory approval for its diagnostic AI technology and expansion of its clinical trial imaging services positions it to capitalize on the growing demand for AI-enhanced cancer diagnosis and treatment development. With its extended financial runway, Median Technologies is positioned to execute its growth strategy through the critical regulatory and commercialization phases ahead.
