Median Technologies Reports Excellent Results from Its Independent Verification Study

Regulatory News:

Median Technologies (FR0011049824, ALMDT, PEA/SME eligible) today announces that it has achieved very positive results from the independent verification study for its CADe/CADx¹ SaMD eyonis² LCS (Lung Cancer Screening).

This evaluation utilizes retrospective patient data from diverse sources, setting the stage for the two forthcoming pivotal studies—analytical validation with the Standalone study (REALITY, MT-LCS-002) and clinical validation with the Multi-Reader Multi-Case study (RELIVE, MT-LCS-004)—in line with discussions during FDA Q-Submissions.

Innovations Leading to Enhanced Performance

The study compared two versions of SaMD eyonis LCS, spotlighting a new algorithm developed in H2 2023 that significantly improved the detection and characterization of malignant lung nodules, achieving an AUC³ of 0.93 with 92% of sensitivity and 85% of specificity at patient level (Youden Index) in a cohort of 300 patients. This marks a major step forward from the 2022 algorithm's AUC of 0.91 with 84% of sensitivity and 87% of specificity at patient level (Youden Index), demonstrating Median's commitment to continuous innovation and excellence in medical technology.

The primary endpoint for the SaMD eyonis LCS used in the independent verification study is the same as the primary endpoint set in the pivotal Standalone study, i.e. measurement of AUC at patient level. The value to be achieved in the eyonis LCS Standalone study for 510(k) clearance and CE marking is an AUC greater than 0.80.

Implications for Global Health

The results obtained in the independent verification study conducted with the new version of the SaMD eyonis LCS add significant momentum to Median Technologies regarding the remaining validation steps leading towards regulatory approvals in the United States and Europe. They also maximize the medico-economic impact the SaMD eyonis LCS could have for the early diagnosis of lung cancer and for the development of screening programs, while strengthening the Company for future negotiations with payers in the United States and Europe.

In order to integrate the new algorithm, Median is now aiming for FDA 510(k) clearance for its CADe/CADx SaMD eyonis LCS in the first quarter of 2025 and CE marking by the end of the first half of 2025.

Strategic Focus and Global Impact

"The integration of the new version of our algorithm, will give us a decisive competitive advantage and significantly impact the early diagnosis of lung cancer—the leading cause of cancer death globally" emphasizes Fredrik Brag, CEO and founder of Median Technologies. "Early diagnosis of lung cancer is already effective and has been reimbursed since 2015 in the United States as part of a screening program that currently covers a target population of 14.5 million Americans. Since July 2022, the use of tissue characterization software has been covered by a temporary reimbursement code of $650 per patient representing a very significant total addressable market for our SaMD eyonis LCS. In Europe, the organization of national lung screening programs for targeted populations is one of the recommendations made by the European Union in the "Europe's Beating Cancer" plan. It has been considerably reinforced by the publication in November 2023 of the 2024-2029 Manifesto Time to accelerate: Together Against Cancer⁴", adds Fredrik Brag.