Median Co., Ltd.

SOPHIA ANTIPOLIS, France--( BUSINESS WIRE )--Regulatory News: Median Technologies ( FR0011049824, ALMDT, PEA/PME scheme eligible, “Median” or “The Company”) announces today that eyonis™ LCS, its proprietary Artificial Intelligence (AI)/machine learning (ML) powered Software as Medical Device (SaMD) for lung cancer screening (LCS), met the primary and all secondary endpoints in REALITY, the first of two pivotal studies required for marketing authorizations in U.S. and Europe. Median’s eyonis™ LCS SaMD is designed for improving the detection and diagnostic accuracy of low-dose computed tomography (LDCT). LDCT imaging is the standard of care globally and is currently the only approved lung cancer screening modality in U.S. and Europe. Fredrik Brag, CEO of Median Technologies said : “These data met our ambition for improving the performance of LDCT with eyonis™ LCS. Now, we are even more excited to report the upcoming RELIVE pivotal data and file for marketing authorizations in H1 2025. We believe that broad implementation of LDCT with eyonis™ LCS has the potential to vastly improve early detection and lead to far more cures, dramatically reducing lung cancer mortality.” The average five-year survival rate for all lung cancer patients is 18.6 percent because only 16 percent of lung cancers are diagnosed at an early stage 2 . Conversely, Stage 1 lung cancer can be cured when detected, with an 80% survival rate after 20 years, where many die from other causes. For Stage 1A cancers that measure 10 mm or less, the 20-year survival rate has been shown to be 92%. Consequently, there is tremendous momentum behind efforts in the U.S., Europe and Asia to increase lung cancer screening and improve its accuracy. Enabling the accurate early detection of lung cancer with eyonis™ LCS could dramatically improve lung cancer survival. Thomas Bonnefont, COO and CCO eyonis™ Business Unit said: “The high performances of our device can not only save lives but also prevent healthy patients undergoing unnecessary medical procedures. This will avoid unnecessary distress for patients and reduce healthcare costs.” Lung cancer screening is recommended by the U.S. Preventive Services Task Force (USPSTF) in adults aged 50 to 80 years who have a 20 pack-year smoking history. The market opportunity includes a population of 14.5 million people in the US alone, currently eligible for a lung cancer screening exam, with an existing potential reimbursement of $650 per exam with a SaMD postprocessing for characterization of malignant vs benign nodules. This represents a total addressable annual market of over $9 billion. The eligible U.S. patient number is expected to rise in the coming years, driven by planned broadening of the eligibility criteria. Similarly, new lung screening program deployments are planned in Europe and Asia . Around $230bn were spent on cancer medical care in 2023 in the US. The vast majority of cancer care costs are incurred in treating advanced cancer patients, versus preventive care such as screening that can save patients’ life. Definitive results from REALITY show that eyonis™ LCS can accurately detect and characterize cancerous nodules. The novel SaMD achieved exceptional results, with an area under the curve (AUC) value of 0.904 at patient level versus an AUC of 0.80 – the minimum value set as a primary endpoint for REALITY. Importantly, 80% of the cancers in the analyzed cohort of REALITY were difficult-to-diagnose Stage 1 cancers. Moreover, the REALITY cohort was enriched compared to real life with small non-spiculated cancers, and large spiculated benign nodules, both of which are challenging for radiologists to diagnose. The pivotal REALITY study ( Clinicaltrials.gov identifier: NCT0657623 ), initiated in July 2023, collected retrospective imaging and clinical data from 1,147 patients from five major cancer centers and hospitals in the US and Europe and two clinical data providers. REALITY evaluated eyonis™ LCS ability to diagnose lung cancer. The objectives were to assess eyonis™ LCS standalone performance in characterizing cancerous vs non-cancerous patients (i.e. “performance at patient level”), and in detecting and characterizing suspicious versus malignant nodules. The primary endpoint of REALITY was determined after consultation with the U.S. regulatory authorities and the primary endpoint was selected to show that eyonis™ LCS would achieve an AUC superior to 0.8. The second pivotal trial, RELIVE, is a Multi-Reader Multi-Case (MRMC) study that will offer clinical validation of eyonis™ LCS to complement the analytical validation already achieved and communicated today with REALITY. All the patient recruitment and relevant patient clinical data for the RELIVE study have already successfully been collected from the participating sites. RELIVE is scheduled for completion in the coming months, with an anticipated data read-out in Q1 2025 and regulatory filings in H1 2025. About eyonis™ LCS: eyonis™ Lung Cancer Screening (LCS) is an artificial intelligence (AI) powered diagnostic tool that uses machine learning (ML) to help analyze imaging data generated with low-dose computational tomography (LDCT) to diagnose cancer at the earliest stages, when it can still be cured in the majority of patients. eyonis™ LCS has been classified by regulators as “Software as Medical Device”, or SaMD, and is the subject of two pivotal studies required for marketing approvals in the U.S. and Europe: REALITY (successfully completed - Clinicaltrials.gov identifier: NCT0657623 ) and RELIVE (ongoing). Filing applications including these pivotal data are scheduled to be submitted for FDA 510(k) premarket clearance and CE marking in H1 2025. In the interim, eyonis™ technology is being used in at clinical research centers. Separately, Median’s AI technology is being sold and deployed via Median’s iCRO business unit , to biopharmaceutical companies performing clinical trials of experimental therapeutics, including the world’s leading pharmaceutical companies in cancer. About Median Technologies: Pioneering innovative imaging solutions and services, Median Technologies harnesses cutting-edge AI to enhance the accuracy of early cancer diagnoses and treatments. Median's offerings include iCRO, which provides medical image analysis and management in oncology trials, and eyonis™, an AI/ML tech-based suite of software as medical devices (SaMD). Median empowers biopharmaceutical entities and clinicians to advance patient care and expedite the development of novel therapies. The French-based company, with a presence in the U.S. and China, trades on the Euronext Growth market (ISIN: FR0011049824, ticker: ALMDT). Median is also eligible for the French SME equity savings plan scheme (PEA-PME). For more information, visit www.mediantechnologies.com . Median Technologies’ Forward-Looking Statements This press release contains forward-looking statements. These statements are not historical facts. They include projections and estimates as well as the assumptions on which these are based, statements concerning projects, objectives, intentions, and expectations with respect to future financial results, events, operations, services, product development and potential, or future performance. These forward-looking statements can often be identified by the words "expects," "anticipates," "believes," "intends," "estimates" or "plans" and any other similar expressions. Although Median's management believes that these forward-looking statements are reasonable, investors are cautioned that forward-looking statements are subject to numerous risks and uncertainties, many of which are difficult to predict and generally beyond the control of Median Technologies, that could cause actual results and events to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. All forward-looking statements in this press release are based on information available to Median Technologies as of the date of the press release. Median Technologies does not undertake to update any forward-looking information or statements, subject to applicable regulations, in particular Articles 223-1 et seq. of the General Regulation of the French Autorité des Marchés Financiers. _____________________________ 1 The accuracy of a diagnostic test is determined by the balance between true positives and false positives. To calculate the ratio, medical professionals use what is referred to as the receiver operating characteristic (ROC) to generate a statistical plot, or curve; the area under the curve (AUC) scores the diagnostic accuracy and can be used to compare different screening methodologies. For reference, a diagnostic test with no discriminatory power (e.g. to discern cancerous from normal tissue) would have an AUC of 0.5 while a perfect test would have an AUC of 1. 2 https://www.mountsinai.org/about/newsroom/2022/lung-cancer-screening-dramatically-increases-long-term-survival-rate

SOPHIA ANTIPOLIS, France--( BUSINESS WIRE )--Regulatory News: Median Technologies ( FR0011049824, ALMDT, PEA/PME scheme eligible, “Median” or “The Company”) announces today it has signed an initial agreement with a Top 10 oncology pharmaceutical company 1 . The agreement aims at conducting AI-based imaging biomarker 2 discovery on the clinical data of a drug candidate. The agreement could lead to a broader collaboration between the pharmaceutical company and Median. The agreement involves Imaging Lab, a dedicated entity of Median’s iCRO Business Unit. Imaging Lab provides biopharma companies with advanced AI-based decision-making capabilities, leveraging patients’ imaging data to provide specific patient selection, prediction of response to therapy, accurate monitoring of disease progression, and early access to safety and efficacy. Median will apply its unique expertise, methods, and know-how in AI-based technologies to identify specific digital signatures (imaging biomarkers) from images, providing meaningful information on the drug responder/non-responder status of the patients. The drug-specific imaging biomarkers could ultimately be utilized as companion diagnostics 3 to select patients who are most likely to benefit from the drug. Fredrik Brag, CEO and Founder of Median Technologies, highlighted: “ We recently announced the selection of Median as preferred provider to a second global Top 3 pharmaceutical group. We are thrilled to announce today the launch of a collaboration with a global Top 10 pharma to support a drug development program with our AI-driven imaging technologies. Pharmaceutical companies are early adopters of AI in their drug development plans and investment in AI by large pharma is growing at a steady pace, creating very positive momentum for Median as a unique AI technology company in the imaging CRO market. AI is now everywhere in drug development and the AI in clinical trials market is expected to reach $6.55 Billion by 2030 4 . AI-driven imaging technologies applied to clinical trials unveil new insights that could determine the success of oncology trials. Providing insights for ‘Go/No-Go’ decisions at an early stage, or to discover predictive imaging biomarkers of patient response to drug candidates are two of the most compelling outcomes. Imaging AI solutions will become the new generation of companion diagnostics, opening unique opportunities in the era of precision medicine.” Nicolas Dano, COO & CCO iCRO said: “ AI-driven imaging insights are the future in oncology drug development. As a native technology company, Median is the only imaging CRO that has AI know-how and experience, giving us a unique competitive advantage to penetrate the Big Pharma market. We are eager to start the collaboration and provide valuable insights to our new partner, helping them with their drug development plans.” About Median Technologies: Pioneering innovative imaging solutions and services, Median Technologies harnesses cutting-edge AI to enhance the accuracy of early cancer diagnoses and cancer treatments. Median's offerings, including iCRO for medical image analysis and management in oncology trials and eyonis™, AI/ML tech-based suite of software as medical devices (SaMD), empower biopharmaceutical entities and clinicians to advance patient care and expedite novel therapies. The French-based company, with a presence in the U.S. and China, trades on the Euronext Growth market (ISIN: FR0011049824, ticker: ALMDT). Median is eligible for the French SME equity savings plan scheme (PEA-PME). For more information: www.mediantechnologies.com 1 Arjun Murthy – Top 15 biopharma companies by Oncology Sales in 2023 2 An imaging biomarker is a “defined characteristic that is measured as an indicator of normal biological processes, pathogenic processes or responses to an exposure or intervention, including therapeutic interventions” - https://www-ncbi-nlm-nih-gov.libproxy1.nus.edu.sg/books/NBK326791/ 3 https://www.fda.gov/medical-devices/in-vitro-diagnostics/companion-diagnostics 4 Explosive Growth Forecasted: AI in Clinical Trials Market Set (openpr.com)

SOPHIA ANTIPOLIS, France--( BUSINESS WIRE )--Regulatory News: Median Technologies (FR0011049824, ALMDT, PEA/SME eligible, “Median” or “the Company”) reports today its business indicators for the first half of 2024, provide an update on recent iCRO 1 successful business achievements. Fredrik Brag, CEO and Founder of Median Technologies said: “iCRO experienced double-digit order backlog growth in one year. The strategy initiated in 2023, leveraging our unique AI capabilities, delivered its first results. H1 2024 revenue was slightly below H1 2023 revenue, due mainly to the residual impact from COVID-19 in China. Chinese bookings improved significantly in H1 2024, and we expect to experience revenue growth in China in the coming quarters. In May, we announced that Median has been selected as a preferred vendor of a Top 3 pharma company. Median is now a preferred imaging services provider to 2 of the Top 3 global pharma groups. We are very proud to have been selected against our biggest competitors by this additional leading oncology pharma with a pipeline 30% bigger than our current largest client. This agreement should significantly increase our revenues in the coming years. This is a clear sign of the quality we provide for our clients and the unique differentiator we bring with our AI expertise. Moreover, we are very pleased to announce that we have been awarded our first deals in Japan and South Korea for a total amount of €3.1 million. These new deals outside China considerably increase Median’s reach on the very dynamic East Asia clinical trial market. We expect these achievements to be major catalysts for strong business growth in the upcoming quarters. We’re very encouraged by the final results of the eyonis™ LCS independent verification study. All the primary endpoint and secondary endpoints were met. Therefore, we have a high degree of confidence in the forthcoming results of the Standalone pivotal study, which will be reported in August.” iCRO: paving the way for growth acceleration Leveraging AI expertise to partner with global players in the pharma industry Median's revised sales strategy, initiated in 2023, underpinned by the Company’s distinctive AI capabilities, targets big pharma groups and strategic partnerships with global CROs 2 . This approach is designed to enhance Median’s iCRO core business, delivering significant added value through its unique AI imaging expertise. The success of the Company’s revised sales strategy is translating into accelerating order backlog 3 growth. Median was awarded its first iCRO projects in Japan and South Korea, extending its reach in the fast-growing East Asian oncology clinical trials market. The project awards consist of two large oncology phase III studies, for a total amount of €3.1 million. These first awards in Asia outside of China are a breakthrough and create excellent momentum for the growth of Median’s iCRO business in this highly dynamic geography. In May, Median was selected as preferred vendor by a Top 3 pharmaceutical company, adding another one of the largest global pharmaceutical companies to its client portfolio. Median Technologies is now a preferred provider for 2 of the Top 3 pharma companies, based on oncology sales. Median will provide imaging services, primarily for late phase clinical trials in the new client’s oncology pipeline. Median’s recognized expertise in AI applied to medical images has served as a powerful technological differentiator throughout the various negotiation phases; this unique asset sets it apart from the standard offering of the Company’s competitors, as well as a significant catalyst for accelerating growth opportunities for Median. H1 2024 revenue at €10.9 million, order backlog at an all-time high of €71.7 million In Q2 2024, the Company's revenue stands at €5.6 million, up by 3.7% from Q1 2024 revenue and 5.7% compared to Q4 2023 revenue. H1 2024 revenues were €10.9 million, versus €11.4 million in H1 2023. The residual impact of COVID-19 in China created temporary revenue headwinds in H1 2024. However, Chinese bookings improved significantly in H1 2024, and the Company expects to experience revenue growth in China in the coming quarters. All the revenue comes from the iCRO business, which provides imaging services to the global bio-pharmaceutical industry. The order backlog is €71.7 million as of June 30, 2024, up by 5.1% compared to the order backlog on March 31, 2024 (€68.2 million) and up by 11% on June 30, 2023 (€64.6 million). As of June 30, 2024, the order backlog is at its highest level ever reached. eyonis ™ LCS: On-Track for Standalone pivotal study readout in August Final results from the eyonis™ LCS Independent Verification Study show continued improvement, all of the primary and secondary endpoints were met. This provides a high degree of confidence for the forthcoming Standalone pivotal study readout, expected in August. Cash of €16 million on June 30, 2024 As of June 30, 2024, Median Technologies' cash and cash equivalents stand at €16 million, compared to €20.9 million as of March 31, 2024. The Company expects operations to be fully financed until the second quarter of 2025. Next financial release on October 24, 2024, after market close: Half Year Financial Report Disclaimer: The preliminary figures set forth above are based on management’s initial review of the Company’s operations for the period ending June 30, 2024, and are subject to revision based upon the finalization of the limited review conducted on the full year financial statements by the Group's statutory auditors. Actual results may differ materially from these preliminary figures as a result of the completion of H1 closing procedures, final adjustments and other developments arising between now and the time that the Company’s financial results are finalized, and such changes could be material. In addition, these preliminary figures are not a comprehensive statement of the Company’s financial results for H1 2024, should not be viewed as a substitute for condensed interim financial statements prepared in accordance with generally accepted accounting principles, and are not necessarily indicative of the Company’s results for any future period. Forward-looking statements: This press release contains forward-looking statements. These statements are not historical facts. They include projections and estimates as well as the assumptions on which these are based, statements concerning projects, objectives, intentions, and expectations with respect to future financial results, events, operations, services, product development and potential, or future performance. These forward-looking statements can often be identified by the words "expects," "anticipates," "believes," "intends," "estimates" or "plans" and similar expressions. Although Median's management believes that these forward-looking statements are reasonable, investors are cautioned that forward-looking statements are subject to numerous risks and uncertainties, many of which are difficult to predict and generally beyond the control of Median Technologies, that could cause actual results and events to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include, but are not limited to, the uncertainties inherent in research and development, future clinical data and analysis, and decisions by regulatory authorities, Median Technologies' ability to take advantage of external growth opportunities and to complete related transactions and/or obtain regulatory approvals, risks associated with intellectual property, any future litigation in this area and the outcome of such litigation, changes in foreign exchange rates and interest rates, volatility in economic conditions the impact of cost containment initiatives and changes of the same, the average number of shares outstanding, as well as those developed or identified in the documents available on the Median Technologies' website and in particular the “Specific Risk Factors” section of the financial annual report for the year ended December 31, 2023, published on April 25, 2024. Median Technologies does not undertake to update any forward-looking information or statements, subject to applicable regulations, in particular Articles 223-1 et seq. of the General Regulation of the French Autorité des Marchés Financiers. About Median Technologies: Pioneering innovative imaging solutions and services, Median Technologies harnesses cutting-edge AI to enhance the accuracy of early cancer diagnoses and treatments. Median's offerings include iCRO, which provides medical image analysis and management in oncology trials, and eyonis™, an AI/ML tech-based suite of software as medical devices (SaMD). Median empowers biopharmaceutical entities and clinicians to advance patient care and expedite the development of novel therapies. The French-based company, with a presence in the U.S. and China, trades on the Euronext Growth market (ISIN: FR0011049824, ticker: ALMDT). Median is also eligible for the French SME equity savings plan scheme (PEA-PME). For more information, visit www.mediantechnologies.com . 1 Imaging Contract Research Organization 2 CROs: Contract Research Organization 3 The order backlog is the sum of orders received but not yet fulfilled. An increase or decrease in the order backlog corresponds to the order intake of the reporting period, net of invoiced services, completed or cancelled contracts, and currency impact for projects in foreign currency (re-evaluated at the exchange rate on closing date). Orders are booked once the customer confirms, in writing, its retention of the Company’s services for a given project. The contract is usually signed a few months after written confirmation.