Press releases - Median Technologies

iBiopsy® Lung Cancer Screening (LCS) CADe/CADx outstanding performance reaches 94.7% sensitivity[2] at 93.3% specificity, based on a cohort of 1,760 patients. With such performance, iBiopsy® LCS CADe/CADx SaMD positions itself to dramatically increase the efficacy of lung cancer screening programs worldwide, which would facilitate saving the lives of millions.

513(g) submission is a key milestone that marks the initiation of Median’s interactions with the FDA. 513(g) submission will allow Median Technologies to determine the best FDA regulatory pathway for iBiopsy® LCS CADe/CADx Software as Medical Device. Median aims to obtain a full device approval and market authorization by the end of 2023, and proceed with subsequent commercialization.

As of December 31, 2021, Median Technologies’ revenue was €20.5 million, a 52% increase compared to 2020 revenue. The order backlog as of December 31, 2021, was €58 million, a €6.3 million increase compared to December 31, 2020 and a €3,8 million increase compared to September 30, 2021. As of December 31, 2021, cash and cash equivalents were €39 million, compared to €16 million as of December 31, 2020.

iBiopsy® Lung Cancer Screening detection performance reaches 94.9% sensitivity for a false positive rate of 1 per CT scan, a performance superior to that of lung CADe systems currently on the market. The particularly high sensitivity of iBiopsy® LCS is a prerequisite for implementing a reliable detection and diagnosis solution for lung cancer screening programs. After detection, the diagnostic component of iBiopsy® LCS characterizes nodules as malignant or benign. Its sensitivity/specificity levels were announced in 2021 and are still unparalleled today.