Median Technologies has achieved a significant breakthrough in lung cancer screening technology with its artificial intelligence-powered software, eyonis™ LCS, successfully meeting its primary endpoint in the pivotal RELIVE clinical trial. The study demonstrated that the AI/ML-based Software as a Medical Device (SaMD) significantly enhanced radiologists' diagnostic accuracy in analyzing lung cancer screening scans (p=0.027).
Clinical Trial Success and Regulatory Path
The RELIVE trial, involving 480 high-risk patients and 16 radiologists, evaluated the software's ability to improve the detection, localization, and characterization of lung nodules while reducing false positives. This success follows the earlier REALITY study, which collected data from 1,147 patients across five major cancer centers in the US and EU.
Fredrik Brag, CEO and Founder of Median Technologies, emphasized the significance of the achievement: "This is truly the most important milestone that Median eyonis™ has achieved yet. We are confident that eyonis™ LCS will contribute to accelerate efforts in the U.S. and Europe by making lung cancer screening more accurate and efficient, especially for early-stage lung cancers."
Addressing Critical Healthcare Needs
The development addresses a crucial gap in lung cancer diagnosis, where currently only 16% of cases are detected at early stages. Early detection is vital, as Stage 1 lung cancer patients can achieve an 80% survival rate after 20 years, with rates reaching 92% for Stage 1A cancers measuring 10mm or less.
Market Potential and Implementation
The technology targets a substantial market opportunity, with 14.5 million eligible individuals in the U.S. alone under current USPSTF screening recommendations. Medicare currently provides reimbursement of $650 per SaMD procedure, creating a significant commercial opportunity.
Technology Implementation and Benefits
eyonis™ LCS utilizes machine learning to analyze low-dose computed tomography (LDCT) scans, aiming to:
- Improve diagnostic accuracy in early-stage detection
- Reduce unnecessary medical procedures
- Decrease healthcare costs associated with late-stage cancer treatment
- Streamline the analysis of LDCT images
Regulatory Timeline and Commercial Outlook
With both pivotal trials now successfully completed, Median Technologies is preparing for:
- FDA 510(k) clearance submission in Q2 2025
- EU CE marking application in Q2 2025
- Anticipated U.S. market launch as early as Q3 2025
The company plans to present additional RELIVE trial data, including secondary endpoints, in upcoming weeks at medical and scientific conferences.
