Median Technologies has announced a significant milestone in its mission to revolutionize lung cancer screening. The company’s proprietary artificial intelligence (AI) and machine learning (ML)-based software, eyonis™ Lung Cancer Screening (LCS), has successfully met the primary endpoint in the RELIVE clinical trial, marking a major achievement in the regulatory pathway for the product.
The RELIVE study was the final pivotal trial required for securing marketing authorization in the United States and Europe. Top-line data from RELIVE demonstrates that Median Technologies eyonis™ LCS, when used in conjunction with radiologists, significantly improves diagnostic accuracy compared to radiologists working alone (p=0.027). This finding reinforces the potential of AI-driven solutions in the early detection of lung cancer, a disease that remains the leading cause of cancer-related deaths worldwide.
The Significance of RELIVE Meeting its Primary Endpoint
By successfully meeting its primary endpoint in the RELIVE study, Median Technologies eyonis™ LCS has completed its clinical validation. This latest achievement further substantiates the analytical validation that was initially established in the REALITY study, an earlier pivotal trial whose results were disclosed in August 2024. Pivotal studies such as RELIVE and REALITY are essential prerequisites for regulatory approval in both the U.S. and EU markets. With these milestones accomplished, Median Technologies is now preparing the necessary regulatory filings. Submissions for the U.S. Food and Drug Administration (FDA) 510(k) clearance and the European Union’s CE marking are scheduled for the second quarter of 2025.
Advancing Lung Cancer Screening with AI/ML-Powered SaMD
Median Technologies eyonis™ LCS is an advanced AI/ML-based Computer-Aided Detection (CADe) and Computer-Aided Diagnosis (CADx) Software as a Medical Device (SaMD). It is specifically engineered to enhance the diagnostic accuracy of radiologists by improving their ability to analyze low-dose computed tomography (LDCT) scans used in lung cancer screening programs.
Lung cancer remains the most lethal form of cancer, largely due to late detection. Current statistics indicate that only 16% of lung cancers are diagnosed at an early stage. Because the majority of cases are detected too late, the overall five-year survival rate for lung cancer patients stands at a dismal 18.6%. However, when detected at Stage 1, lung cancer becomes highly treatable. Data suggests that the survival rate for Stage 1 patients can reach 80% after 20 years, and for cases where tumors measure 10mm or less, survival rates can climb as high as 92% over the same period.
A Game-Changing Solution for Early Detection
“This is truly the most important milestone that Median Technologies eyonis™ has achieved yet,” said Fredrik Brag, CEO and Founder of Median Technologies. “With RELIVE successfully meeting its primary endpoint, we confirm the game-changing potential of our AI/ML-based Software as a Medical Device for lung cancer screening. We are confident that eyonis™ LCS will contribute to accelerating lung cancer screening efforts in the U.S. and Europe by making the process more accurate and efficient, particularly for early-stage lung cancers.”
Brag emphasized that widespread adoption of LDCT screening, enhanced by Median Technologies eyonis™ LCS, has the potential to substantially improve lung cancer diagnosis. By addressing existing bottlenecks—such as the complexity and time required for LDCT scan analysis—the software can help save lives while reducing overall healthcare expenditures. Late-stage lung cancer treatments are significantly more expensive and burdensome compared to early interventions.
The Broader Impact on Healthcare Costs and Patient Well-Being
Early and accurate screening with eyonis™ LCS is expected to deliver substantial benefits beyond improved survival rates. “We believe timely screening of high-risk populations using eyonis™ LCS can enable doctors to save more lives while further reducing medical costs,” Brag added. “Furthermore, using eyonis™ LCS can not only save lives but also prevent healthy patients from undergoing unnecessary medical procedures. This will avoid unnecessary distress for patients and afford payers tremendous cost savings on unnecessary procedures, in addition to preventing the even greater costs of palliative care required for late-stage lung cancer management.”
The RELIVE Clinical Trial: Design and Findings
RELIVE was designed as a multi-reader, multi-case (MRMC) study conducted on a cohort of 480 patients classified as high-risk for developing lung cancer. The primary objective of the trial was to demonstrate the superiority of eyonis™ LCS in enhancing the diagnostic accuracy of radiologists in lung cancer screening. A total of 16 radiologists participated in the study, evaluating LDCT lung cancer screening scans with and without the assistance of eyonis™ LCS.
The study assessed multiple aspects of lung cancer detection, including:
- Detection and localization of lung nodules
- Characterization of nodules to distinguish between benign and malignant cases
- Reduction of false positives
- Optimization of clinical decision-making to avoid unnecessary follow-up procedures
The top-line data from RELIVE demonstrated a statistically significant improvement (p=0.027) in diagnostic performance when radiologists used eyonis™ LCS, compared to radiologists working alone. These findings underscore the potential of eyonis™ LCS to improve early detection rates, enhance efficiency in radiology workflows, and reduce costs associated with late-stage lung cancer treatment.
Next Steps: Secondary Endpoint Analysis and Future Communications
While the primary endpoint of RELIVE has been successfully met, additional analyses are underway. Secondary endpoint data is being examined and will be disclosed in the coming weeks. The detailed findings will be shared in upcoming communications from Median Technologies and presented at major medical and scientific conferences. More information about the RELIVE study can already be accessed via ClinicalTrials.gov under the study ID NCT06751576.
The First Pivotal Study: REALITY
Prior to RELIVE, the REALITY study served as the first pivotal trial for eyonis™ LCS. Announced in August 2024, REALITY was a large-scale study that collected retrospective imaging and clinical data from 1,147 patients. The trial primarily evaluated eyonis™ LCS’s ability to diagnose and characterize cancerous versus non-cancerous cases at the patient level, as well as its capability to detect and characterize suspicious versus malignant nodules using LDCT lung screening scans.
Both the RELIVE and REALITY studies were conducted using retrospective imaging and clinical data collected from five major cancer centers and hospitals across the U.S. and Europe. Additionally, data was sourced from two U.S.-based data providers to ensure a diverse and representative dataset.
A New Era in Lung Cancer Screening
With the successful completion of the RELIVE trial, Median Technologies is now in the final phase of securing regulatory approvals in the U.S. and EU. The company’s eyonis™ LCS AI/ML-powered software stands at the forefront of a new era in lung cancer screening, providing an advanced, reliable, and highly effective solution to improve early detection rates.
The potential impact of this technology is enormous:
- Earlier detection means significantly higher survival rates.
- AI-enhanced screening can improve efficiency and accuracy for radiologists.
- Reduction in unnecessary procedures minimizes patient stress and medical costs.
- Wider implementation of AI-driven screening could lead to a major public health breakthrough.
As the healthcare industry continues to embrace AI-driven innovations, solutions like Median Technologies eyonis™ LCS could play a transformative role in cancer diagnostics. With the final regulatory submissions now in progress, Median Technologies is well-positioned to bring its groundbreaking lung cancer screening technology to the market, ultimately improving outcomes for patients worldwide.
