Median Technologies announced that the Company has received feedback from the United States Food and Drug Administration regarding the Q-submission phase initiated on May 2, 2022 for its iBiopsy Lung Cancer Screening (LCS) AI/ML tech-based CADe/CADx Software as Medical Device (SaMD) and announces completion of this phase. The Q-submission phase is a major regulatory step which allows regular and in-depth discussions with the FDA on key topics such as pivotal study protocols. Further to this Q-submission phase, Median's SaMD is better tailored to fit the FDA's expectations and market needs.

As next steps, Median Technologies, having finalized its pivotal study protocols, is now getting ready for pivotal study execution by the end of Second Quarter 2023, as planned, once all imaging and clinical data collection and preparation as well as reader training are completed. Likewise, Median still targets obtaining the FDA 510(k) clearance for its iBiopsy LCS CADe/CADx SaMD in the first half of 2024, subject to FDA review requirements. iBiopsy is based on the most advanced technologies in Artificial Intelligence (AI) and Data Science (DS), benefiting from Median's expertise in medical image processing.

iBiopsy targets the development of AI/ML tech-based Software of Medical Devices (SaMD), to be used in several indications for which there are unmet needs regarding early diagnosis, prognosis and treatment selection in the context of precision medicine. iBiopsy currently focuses on Lung Cancer, Liver Cancer (HCC) and Liver Disease (NAFLD/NASH).