Median Technologies to share positive pivotal data for eyonis LCS diagnostic software as medical device at the IASLC 2024 World Conference on Lung Cancer

Regulatory News:

Median Technologies (FR0011049824, ALMDT, PEA/SME eligible, “Median” or “The Company”) announces today that the Company will be sharing information on its proprietary AI/ML-powered SaMD, eyonis LCS, including recently announced data from the pivotal REALITY study, at Booth #2601 during the 2024 World Conference on Lung Cancer (WCLC), being held in San Diego, CA, USA, from September 7-10, 2024. The WCLC, the premier world conference on lung cancer, is organized by the International Association for the Study of Lung Cancer (IASLC), a global multidisciplinary association dedicated to eradication of all forms of lung cancers.

eyonis LCS is designed to improving the detection and diagnostic accuracy of LDCT in lung cancer screening procedures. LDCT imaging is the standard of diagnostic care globally and is currently the only approved lung cancer screening modality in U.S. and Europe. The average five-year survival rate for all lung cancer patients is 18.6 percent because only 16 percent of lung cancers are diagnosed at an early stage². Conversely, Stage 1 lung cancer can be cured when detected, with an 80% survival rate after 20 years, where many die from other causes. For Stage 1A cancers that measure 10 mm or less, the 20-year survival rate has been shown to be 92%.

The Company released in August the definitive results from the first of the two pivotal eyonis LCS clinical studies, REALITY (Clinicaltrials.gov identifier: NCT0657623) evaluating the standalone performance of the medical device in characterizing cancerous vs non-cancerous patients (i.e. “performance at patient level”), and in detecting and characterizing suspicious versus malignant nodules. Despite the inclusion of many challenging LDCT images, the eyonis LCS SaMD achieved exceptional results and met all study primary and secondary endpoints with statistical significance and achieved an area under the curve (AUC) value of 0.904 at patient level versus an AUC of 0.80 – the minimum value set as the primary endpoint for REALITY.

REALITY analyses were conducted on data from a cohort of 1,147 patients from five major cancer centers and hospitals in the US and Europe and two clinical data providers. Importantly, 80% of the cancers in the analyzed cohort of REALITY were difficult-to-diagnose Stage 1 cancers. Moreover, the REALITY cohort was enriched compared to real life with small non-spiculated cancers, and large spiculated benign nodules, both of which are challenging for radiologists to diagnose.