On February 28, 2023 Median Technologies (ALMDT:PA) reported new and breakthrough results for its iBiopsy Lung Cancer Screening (LCS) AI/ML tech-based CADe/CADx1 Software as Medical Device (SaMD) to characterize malignant lung nodules in low dose CT scans (LDCT) (Press release, MEDIAN Technologies, FEB 28, 2023, View Source [SID1234627933]).
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New results released today demonstrate considerable increase of Median’s proprietary algorithms performance with a sensitivity2 of 96.5% for a specificity3 of 97.2% on end-to-end lung nodule detection and malignancy characterization. These results complement the results released previously (March 22, 2022), which were based on a cohort of 1,760 patients and showed a 94.7% sensitivity at a 93.3% specificity. New results are calculated on a much larger cohort of 9,863 patients corresponding to 195,943 nodules (vs. 16,789 lung nodules in March 2022). Consistent with previously released results, the performance corresponds to end-to-end detection and characterization at nodule level.
"On February 27, 2023 we announced the completion of the Q-Submission phase with the FDA regarding clinical protocols pre-submission, a major milestone in the roadmap of our iBiopsy LCS CADe/CADx SaMD. Our pivotal study protocols are now finalized and ready for study execution. Today, with the release of our improved performance results, we are more than ever confident for the next steps which will drive our iBiopsy LCS CADe/CADx SaMD to the FDA clearance. Our next milestone is now the execution of the pivotal studies, based on imaging and clinical data we started to collect at the end of 2022 from very prestigious clinical sites and cancer centers in the US and Europe", highlights Fredrik Brag, CEO and founder of Median. "Subsequent to this breakthrough performance, we recently filed two patents", Brag added.
Results will be presented at the European Congress of Radiology (ECR) AIX Theater, on Wednesday, 1 March, at 4:00 pm CET and on Thursday, 2 March at 1:30 pm CET. Median’s team will be available at booth #AI-35 for the duration of the technical exhibition (March 1-4).
The European Congress of Radiology (ECR) organized by the European Society of Radiology (ESR) is the premier European event in radiology and the second largest in the world. The congress conveys more than 20,000 with a split of more than 10,000 professional delegates (radiologists, technologists etc.), and ~8,000 industry participants (imaging modalities, PACS etc.). Radiology professionals from Europe and beyond attend to gather knowledge through educational courses, to see the latest innovations presented by technical exhibitors, and to discover groundbreaking research from scientific paper presentations. More about the ECR: View Source
About iBiopsy: 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 as 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)
Forward-looking statements: This press release contains express or implied information and statements that may be considered forward-looking information and statements about Median Technologies. They are not historical facts. Such information and statements include financial projections that are based on certain assumptions and assessments made by Median Technologies’ management in light of its experience and perception of historical trends, current economic and industry conditions, expected future developments and other factors it deems relevant. These forward-looking statements include statements that generally use conditional verbs and contain words such as "expects", "anticipates", "believes", "intends", "plans" or "estimates" and variations and conjugations thereof and words of similar import. Although Median Technologies’ management believes that the forward-looking statements and information are reasonable, Median Technologies’ shareholders and other investors are cautioned that the realization of these expectations is inherently subject to various known and unknown risks and uncertainties that are difficult to predict and generally beyond the control of Median Technologies. These risks could cause actual results and developments to differ materially from those expressed, implied or projected in the forward-looking statements. This press release contains only summary information and should be read in conjunction with the public information filed by Median Technologies with the AMF and that are available on Median Technologies’ website. Other than as required by applicable law, Median Technologies is issuing this press release as of the date hereof and does not undertake to update or revise any forward-looking information or statements.