Median Technologies (FR0011049824, ALMDT, PEA/PME scheme eligible) announced that its AI-powered diagnostic tool, eyonis™ LCS, met the primary and all secondary endpoints in the REALITY study, the first of two pivotal trials required for marketing approval in the U.S. and Europe. eyonis™ LCS, a Software as a Medical Device (SaMD), enhances the detection and diagnostic accuracy of low-dose computed tomography (LDCT) for lung cancer screening.
CEO Fredrik Brag stated, “The REALITY study data validate our goal to improve LDCT performance with eyonis™ LCS. We’re eager to report the RELIVE pivotal data and file for market authorization in H1 2025. Early implementation of LDCT with eyonis™ LCS could significantly enhance early detection, increasing cure rates and reducing lung cancer mortality.”
Lung cancer is often detected late, with only 16% of cases identified at an early stage, contributing to a low overall five-year survival rate of 18.6%. However, early-stage lung cancer (Stage 1) has an 80% survival rate over 20 years, with some Stage 1A cancers (≤10 mm) showing a 92% survival rate. Early detection with eyonis™ LCS could therefore greatly improve outcomes.
REALITY, initiated in July 2023, involved 1,147 patients across five major cancer centers in the U.S. and Europe, as well as data from two clinical providers. The study assessed eyonis™ LCS in characterizing cancerous versus non-cancerous patients and identifying malignant versus suspicious nodules. eyonis™ LCS achieved a patient-level AUC of 0.904, surpassing the primary endpoint of 0.80. Notably, 80% of the cancers in the REALITY cohort were challenging Stage 1 cancers, and the cohort included complex cases, such as small non-spiculated cancers and large spiculated benign nodules.
Thomas Bonnefont, COO and CCO of the eyonis™ Business Unit, emphasized the potential of eyonis™ LCS to save lives while reducing unnecessary medical procedures and healthcare costs. The U.S. Preventive Services Task Force recommends lung cancer screening for adults aged 50 to 80 with a significant smoking history, representing a market of 14.5 million eligible individuals in the U.S. alone, and a potential annual market value exceeding $9 billion. Expansion of eligibility criteria is anticipated, along with new screening programs in Europe and Asia.
The RELIVE study, the second pivotal trial, is a Multi-Reader Multi-Case (MRMC) study designed to provide clinical validation of eyonis™ LCS. It is scheduled for completion in the coming months, with results expected in Q1 2025, and regulatory submissions planned for H1 2025.
About eyonis™ LCS: eyonis™ LCS uses AI and machine learning to analyze LDCT imaging data for early-stage lung cancer diagnosis, classified as SaMD by regulators. It is currently under pivotal study in REALITY (successfully completed) and RELIVE (ongoing). Regulatory filings for FDA 510(k) premarket clearance and CE marking are expected in H1 2025. The technology is also in use at clinical research centers and through Median’s iCRO business unit for clinical trials of cancer therapeutics.
About Median Technologies: Median Technologies develops innovative imaging solutions and AI-powered diagnostics to enhance early cancer detection and treatment. Its services include iCRO for oncology trials and eyonis™, an AI/ML-based suite of SaMD. The company operates in the U.S., Europe, and China and is listed on the Euronext Growth market (ISIN: FR0011049824, ticker: ALMDT).
