Median Technologies Reports Its Business Activity for the First Half of 2023 and Announces the First Step of Its Refinancing Plan

Regulatory News:

Median Technologies (Euronext Growth - ALMDT) reports today its business indicators for the first half of 2023 for the iCRO activity (non-audited figures) and the iBiopsy activity.

"The second quarter of 2023 confirms the recovery of our iCRO activity, which has seen our revenue and order backlog increase compared with the preceding quarters", Fredrik Brag, CEO and founder of Median Technologies said. "When it comes to our iBiopsy LCS CADe/CADx Software as Medical Device, the design of our pivotal validation plan has been finalized since March 2023. We are currently finalizing the initiation of the academic clinical sites involved in carrying out our two pivotal studies and are aiming to obtain marketing authorizations of iBiopsy LCS CADe/CADx Software as Medical Device on the US market as well as the CE marking for the European market, in 2024. Moreover, the initiatives that we announced in April 2023 to reinforce the Company's equity are bearing fruit with a securities purchase agreement signed with our long-term shareholder, Celestial Successor Fund, LP, for the issuance of convertible bonds for an amount of €10 million with a maturity of 7 years. These initiatives are aimed at extending the outlook for the Company's financing until 2025".

Confirmation of the recovery of iCRO activity in H1 2023

In Q2 2023, the Company's revenue stands at €5.8M, up by 3.6% from Q1 2023 and 13.7% compared to Q4 2022 revenue. Revenue from the first 6 months of 2023 is €11.4M, which is an increase from revenue in H2 2022 (€11.1M). All the revenue comes from the iCRO¹ business, which provides services to the global bio-pharmaceutical industry for image management in oncology clinical trials.

The order backlog² is €64.6 M as at June 30, 2023, which is up by 4.2% compared to the order backlog on March 31, 2023 and 6.3% compared to the order backlog on December 31, 2022. As at June 30, 2023, the order backlog was at its highest level ever reached and has been growing over the last three quarters.

iBiopsy: onboarding of the academic clinical sites involved in the pivotal validation plan in progress for iBiopsy LCS CADe/CADx Software as Medical Device

In February 2023, the Company announced the completion of the preliminary submission phase with the FDA (Q-submission). This phase seeks to clarify and implement the FDA’s expectations on key topics including pivotal study protocols for the iBiopsy Lung Cancer Screening (LCS) CADe/CADx Software as Medical Device. These protocols have now been defined and will be used for the pivotal validation plan made of a standalone performance study and a Multi-Reader Multi-Case (MRMC) clinical trial.