On July 11, 2022 Median Technologies (ALMDT:PA) (Paris:ALMDT) reported its business indicators for the first half of 2022 (Press release, MEDIAN Technologies, JUL 11, 2022, View Source [SID1234616589]).

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Steady growth of revenue

Following record revenues in Q1 2022 of €5.7 million, Median Technologies continued its strong growth with Q2 2022 revenues of €7.0 million, which is a 43% increase versus Q2 2021 (€4.9 million). First half revenue stood at €12.7 million on June 30, 2022, up 25% versus the same period year ago (€10.1 million). Revenues are generated entirely from the iCRO1 business, which provides services for image management in oncology trials to the biopharmaceutical industry worldwide.

The order backlog totaled €60 million on June 30, 2022, up 14.3% relative to June 30, 2021 (€52.5 million). Median has overcome operational challenges caused by the lockdown in Shanghai region, especially with regards to handling tenders, which translated in a limited and temporary decrease of €2.2 million of the order backlog versus March 30th, 2022. The growth of our business in China remains solid.

On June 30, 2022, cash and cash equivalents amounted to €28.2 million. The temporary closure of official administrative services in Shanghai delayed the invoicing process and the collection of customer receivables. The group estimates current delayed payments at €2.5 million. Since the end of the Shanghai lockdown, relations between Median Technologies and official administrative services are gradually recovering their normal course and the company expects the payment delays to be caught up during Q3 2022.

"The growth momentum of our business continued during the second quarter of 2022, with record quarterly revenues, up 43% versus the same period year ago. Our affiliate in China overcame the challenge of the lockdown in Shanghai region and expectations for the year remain unchanged", indicated Fredrik Brag, CEO and founder of Median Technologies.

Median confirms its objective to obtain marketing approval in Q4 2023 for its Software as Medical Device iBiopsy LCS CADe/CADx

In March 2022, the company announced outstanding performances for the combined malignant/benign detection and characterization capabilities of its iBiopsy LCS CADe/CADx2 software as medical device based on Artificial Intelligence and Machine Learning technologies (press release of March 22). The excellent performance of iBiopsy LCS CADe/CADx in terms of sensitivity and specificity could open new perspectives for the early diagnosis of lung cancer and the implementation of massive screening programs for this cancer, which is currently the most deadly in the world. Moreover, these results come at a time when the pharmaceutical industry is heavily investing to position new drug candidates on early stages of the disease.

Simultaneously, Median Technologies has initiated discussions with the FDA in preparation for the launch of the iBiopsy LCS CADe/CADx pivotal study at the end of 2022: following the FDA’s response to its 513(g) filing, Median will proceed with a 510k submission to file for marketing approval with the FDA for its iBiopsy LCS CADe/CADx software as medical device. Median Technologies also initiated a Q-submission process on May 2, with the aim of obtaining the FDA’s opinion on several elements including the pivotal trial protocols and potential predicates. This process will continue through the third quarter of 2022.

The significant advancements of the second quarter, allow Median to confirm its objective of obtaining marketing authorization on the US market in Q4 2023 for its Software as Medical Device iBiopsy LCS CADe/CADx.

New synergies between the iCRO and iBiopsy activities

During ASCO (Free ASCO Whitepaper) annual conference, Median Technologies announced the creation of Imaging Lab, a new and highly differentiated iCRO entity focused on leveraging AI, data mining and radiomics technologies to exploit imaging data for oncology clinical trials. This creation expands the portfolio of services provided by the company to the biopharmaceutical industry and materializes the convergence between the iCRO division activities and those of iBiopsy.