Artificial intelligence cancer diagnostic company, Median Technologies (EPA: ALMDT), and the European Investment Bank (EIB) have agreed on a new loan facility worth €37.5 million, and also an equity line for approximately €10 million with IRIS Capital Investment (IRIS).
The company announced on Friday that it would use the funds for regulatory approval from the Food and Drug Administration (FDA) for its eyonis Lung Cancer Screening (LCS) Software.
Additionally, Median and the EIB have agreed to extend the maturity of the company’s existing 2020 loan by six months, moving it from April to October 2025, pending the signing of legal documentation. Median expects to finalize the legal documentation for both the 2025 loan and the 2020 loan extension in Q1 2025.
The Eyonis tech is an AI-powered diagnostic device that employs machine learning to analyze imaging data generated by low-dose computed tomography (LDCT).
It detects lung cancer at its earliest stages when it remains curable for many patients. Regulators have classified the Eyonis LCS as “Software as Medical Device” (SaMD). Two pivotal studies, REALITY and RELIVE, are supporting its marketing approvals in the U.S. and Europe. Applications for FDA 510(k) premarket clearance and CE marking are scheduled for submission in 2025.
“The imminent drawdown of the first €4 million tranche from the IRIS equity line, the extension of the EIB’s 2020 loan maturity from April to October 2025 combined with the implementation of significant operational improvements to enhance the profitability of the iCRO business and decrease our cash burn rate, enable us to extend the company’s cash runway into Q4, 2025 and achieve our upcoming 2025 key value inflection milestones,” said Fredrik Brag, CEO and founder of Median Technologies.
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Median nearly ready to share results from second study
Meanwhile, Median’s AI technology is actively sold and deployed across various cancer indications through its iCRO business unit. This unit collaborates with leading pharmaceutical companies conducting clinical trials for experimental cancer therapeutics.
Furthermore, the company confirms it is on track to share results from its second pivotal study, RELIVE, in early 2025.
This study tests whether radiologists can diagnose lung cancer more effectively using the Eyonis LCS device. The first study, REALITY, showed that Eyonis LCS met all major goals and confirmed its effectiveness.
Regulatory filings for U.S. FDA approval and the European CE mark will be submitted in mid-2025. The company anticipates the device receiving U.S. approval by late 2025 and European approval by early 2026.
The cancer diagnostics market is substantial and growing rapidly.
Data from Global Market Insights indicates the market was valued at approximately USD$158.7 billion in 2024, with a projected compound annual growth rate (CAGR) of 9 per cent from 2025 to 2034. This growth is driven by technological advancements, rising cancer prevalence, and increasing awareness of the importance of early detection.
Neko Health and Breath Diagnostics are two companies making strides in cancer detection and diagnosis through innovative approaches.
Neko Health, co-founded by Spotify’s Daniel Ek, offers non-invasive body scans capable of identifying health issues such as skin cancer. Its technology focuses on making preventive healthcare more accessible and has recently attracted significant investment for expansion.
Meanwhile, Breath Diagnostics is developing the OneBreath system, a non-invasive platform that detects lung cancer and other diseases by analyzing biomarkers in a patient’s breath. This portable and cost-effective solution aims to revolutionize early disease detection.
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