Median Technologies Announces Pivotal REALITY Study of Its eyonis LCS Lung Cancer Diagnostic Met All Primary and Secondary Endpoints

Regulatory News:

Median Technologies (FR0011049824, ALMDT, PEA/PME scheme eligible, “Median” or “The Company”) announces today that eyonis LCS, its proprietary Artificial Intelligence (AI)/machine learning (ML) powered Software as Medical Device (SaMD) for lung cancer screening (LCS), met the primary and all secondary endpoints in REALITY, the first of two pivotal studies required for marketing authorizations in U.S. and Europe.

Median’s eyonis LCS SaMD is designed for improving the detection and diagnostic accuracy of low-dose computed tomography (LDCT). LDCT imaging is the standard of care globally and is currently the only approved lung cancer screening modality in U.S. and Europe.

Fredrik Brag, CEO of Median Technologies said: “These data met our ambition for improving the performance of LDCT with eyonis LCS. Now, we are even more excited to report the upcoming RELIVE pivotal data and file for marketing authorizations in H1 2025. We believe that broad implementation of LDCT with eyonis LCS has the potential to vastly improve early detection and lead to far more cures, dramatically reducing lung cancer mortality.”

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%.

Consequently, there is tremendous momentum behind efforts in the U.S., Europe and Asia to increase lung cancer screening and improve its accuracy. Enabling the accurate early detection of lung cancer with eyonis LCS could dramatically improve lung cancer survival.

Thomas Bonnefont, COO and CCO eyonis Business Unit said: “The high performances of our device can not only save lives but also prevent healthy patients undergoing unnecessary medical procedures. This will avoid unnecessary distress for patients and reduce healthcare costs.”

Lung cancer screening is recommended by the U.S. Preventive Services Task Force (USPSTF) in adults aged 50 to 80 years who have a 20 pack-year smoking history. The market opportunity includes a population of 14.5 million people in the US alone, currently eligible for a lung cancer screening exam, with an existing potential reimbursement of $650 per exam with a SaMD postprocessing for characterization of malignant vs benign nodules. This represents a total addressable annual market of over $9 billion. The eligible U.S. patient number is expected to rise in the coming years, driven by planned broadening of the eligibility criteria. Similarly, new lung screening program deployments are planned in Europe and Asia. Around $230bn were spent on cancer medical care in 2023 in the US. The vast majority of cancer care costs are incurred in treating advanced cancer patients, versus preventive care such as screening that can save patients’ life.