Median Technologies will use the funding towards initiatives including its quest for FDA approval of eyonis LCS. Image credit: Marian Weyo via Shutterstock

Median Technologies has secured up to €47.5m ($49.9m) to support the regulatory filing and commercialisation efforts for its suite of artificial intelligence (AI)-powered early lung cancer screening (LCS) software in the US and EU.

The French company’s eyonis LCS, which met all primary and secondary endpoints in its 2024 REALITY study, is a software-as-a-medical device (SaMD) suite of tools designed to enhance the detection and diagnostic accuracy of low-dose computed tomography, the global standard of care for lung cancer screening.

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Up to €37.5m of Median’s funding will come from a new loan facility with the European Investment Bank (EIB), and €10m from an equity line with IRIS Capital Investment.

Median intends to use the funds towards activities including the receipt of market approval for eyonis LCS from the US Food and Drug Administration (FDA), gaining a CE marking in Europe, and complete ongoing active commercialisation partnership discussions with AI diagnostic providers in the US.

Median Technologies founder and CEO Fredrik Brag stated that factors including the imminent drawdown of the first €4m tranche from the IRIS equity line will enable the company to extend its cash runway into the fourth quarter of 2025 and achieve its upcoming 2025 key value inflection milestones.

Tranches of the new EIB loan, which is currently in its final stages of authorisation, will be made available upon completion of certain undisclosed milestones, with successful completion of these milestones set to extend the cash runway beyond the fourth quarter of 2025 and “well into 2026”, Brag added.

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“I’d like to thank EIB and IRIS for their confidence as the combination of these financings enables us to bring eyonis LCS to commercialisation,” said Brag.

“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.”

In other AI cancer diagnostic news, a new study from Lunit AI has demonstrated the value of its AI-powered pathology tools in improving human epidermal growth factor receptor 2 (HER2) biomarker evaluation in metastatic colorectal cancer (mCRC) patients undergoing HER2-targeted therapy.