Median Technologies eyonis lung cancer screening (LCS) diagnostic has met the primary endpoint in a second pivotal study ahead of planned regulatory clearance submissions in the US and European Union (EU).

Incorporated with AI and machine learning (ML), the French company’s eyonis LCS is a software as a medical device (SaMD) designed to enhance the detection and diagnostic accuracy of low-dose computed tomography (LDCT) scans, the global standard of care (SoC) for lung cancer screening.

Positive top line data came courtesy of RELIVE, the company’s multi-reader multi-case (MRMC) study of a 480-patient cohort, which aimed to demonstrate that eyonis was capable of improving clinicians’ diagnostic accuracy in the analysis of LDCT scans. The trial met its primary endpoint, showing that when used alongside a radiologist, the diagnostic achieved a statistically significant improvement of p=0.027 over a radiologist alone.

According to the company, eyonis aids in the detection, localisation and characterisation of lung nodules by reducing false positives and driving clinical management to avoid unnecessary follow-up procedures.

Median founder and CEO Fredrik Brag commented: “With RELIVE successfully meeting the primary endpoint, we confirm the game-changing potential of our AI/ML-based SaMD for lung cancer screening.

“We believe timely screening of the high-risk populations using eyonis LCS can enable doctors to save more lives while further reducing medical costs.”

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RELIVE is Median’s second pivotal study. A pre-requisite for regulatory submissions towards achieving 510(k) clearance from the US Food and Drug Administration (FDA) and gaining a CE mark in the EU, the company now intends to submit eyonis for regulatory approvals in the second quarter of 2025.

Eyonis previously met all primary and secondary endpoints in last year’s REALITY study. By achieving an area under the curve (AUC) value of 0.904 at a patient level, the study surpassed the primary endpoint target of an AUC of 0.8, indicating that eyonis LCS could detect and characterise cancerous nodules accurately.

Last month, Median secured €47.5m ($49.9m) to support the regulatory filing and commercialisation efforts for eyonis, with €37.5m ($38.4m) of Median’s funding originating from a new loan facility with the European Investment Bank (EIB), and €10m ($10.2m) from an equity line with IRIS Capital Investment.