(San Diego, CA, USA, September 7-10, 2024)
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eyonis™ LCS is a proprietary Software as a Medical Device (SaMD) system powered by artificial intelligence (AI) / machine learning (ML) for the diagnosis and early detection of lung cancer.
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eyonis™ LCS achieved unmatched standalone accuracy (AUC1=0.904) in assessing low-dose computed tomography (LDCT) images, in the first recently completed pivotal study
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The median will report topline data from the second pivotal eyonis™ LCS study in Q1 2019.
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Regulatory filings for eyonis™ LCS in the US and Europe are scheduled for the first half of 2019.
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The eyonis™ median team will share the latest eyonis™ LCS data and meet WCLC attendees at booth #2601
SOPHIA ANTIPOLIS, France–(BUSINESS WIRE)–Normativa News:
Median Technologies (FR0011049824, ALMDT, PEA/PMI eligible, “Mediana” or “The Company”) announces today that the Company will share information on its proprietary AI/ML-based SaMD, eyonis™ LCS, including recently announced data from the pivotal REALITY study, at booth #2601 during the 2024 World Conference on Lung Cancer (WCLC), to be held in San Diego, CA, USA, from September 7-10, 2024. The WCLC, the world’s leading conference on lung cancer, is organized by the International Association for the Study of Lung Cancer (IASLC), a global, multidisciplinary association dedicated to the eradication of all forms of lung cancer.
eyonis™ LCS is designed to improve the detection and diagnostic accuracy of LDCT in lung cancer screening procedures. LDCT imaging is the global standard of care and is currently the only lung cancer screening modality approved in the United States and Europe. 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. In contrast, stage 1 lung cancer can be cured when detected, with an 80 percent survival rate after 20 years, where many die from other causes. For stage 1A tumors measuring 10 mm or less, the 20-year survival rate has been shown to be 92 percent.
The company released in August the final results of the first of two pivotal eyonis™ LCS clinical studies, REALITY (Clinicaltrials.gov identifier: NCT0657623) evaluating the stand-alone performance of the medical device in characterizing cancerous versus non-cancerous patients (i.e., “patient-level performance”) and in detecting and characterizing suspicious versus malignant nodules. Despite the inclusion of many challenging LDCT images, eyonis™ LCS SaMD achieved outstanding results and met all primary and secondary endpoints of the study with statistical significance and achieved a patient-level area under the curve (AUC) of 0.904 versus an AUC of 0.80, the minimum value set as the primary endpoint for REALITY.
– A message from our partner –
REALITY analyses were conducted on data from a cohort of 1,147 patients from five major cancer centers and hospitals in the United States and Europe and two clinical data providers. Importantly, 80% of tumors in the REALITY cohort analyzed were difficult-to-diagnose stage 1 tumors. Additionally, the REALITY cohort was enriched from real life with small non-spiculated tumors and large benign spiculated nodules, both of which are difficult for radiologists to diagnose.
With eyonis™ LCS, Median Technologies is working to provide the U.S. and European lung cancer medical communities with a unique software-as-medical-device breakthrough to help healthcare professionals accelerate lung cancer screening programs. Increased accuracy with eyonis™ LCS can help save lives and reduce the stress and costs associated with unnecessary procedures.
About eyonis™ LCS: eyonis™ LCS Lung Cancer Screening (LCS) is an artificial intelligence (AI)-based diagnostic device that uses machine learning to help analyze imaging data generated with low-dose computed tomography (LDCT) to diagnose lung cancer in its early stages, when it can still be cured in most patients. eyonis™ LCS has been classified by regulators as a “Software as a Medical Device,” or SaMD, and is the subject of two pivotal studies seeking marketing approvals in the U.S. and Europe: REALITY (successfully completed) and RELIVE (ongoing). Filing applications including this pivotal data are scheduled to be submitted for FDA 510(k) premarket clearance and CE Mark in 2025. Separately, Median’s AI technology is sold and distributed across all oncology indications, through Median’s iCRO Business Unitto companies conducting clinical trials of experimental therapies, including the world’s leading cancer pharmaceutical companies.
About the 2024 IASLC World Conference on Lung Cancer: The International Association for the Study of Lung Cancer (IASLC) World Conference on Lung Cancer (WCLC) is an immersive scientific meeting where more than 5,000 leading experts, researchers and oncologists come together to showcase cutting-edge advances in lung cancer research, treatment modalities and personalized therapies, fostering collaboration towards a world free from the burden of lung cancer. For more information on WCLC 2024, visit
About Median Technologies: Median Technologies, a pioneer of innovative imaging solutions and services, leverages cutting-edge artificial intelligence to improve the accuracy of early cancer diagnosis and treatment. Median’s offerings include iCRO, which provides medical image analysis and management in oncology trials, and eyonis™, a suite of software-as-a-medical-device (SaMD) AI/ML technologies. Median enables biopharmaceutical entities and physicians to improve patient care and accelerate the development of new therapies. The France-based company, with a presence in the U.S. and China, is listed on the Euronext Growth Market (ISIN: FR0011049824, ticker: ALMDT). Median is also eligible for the French SME equity savings plan (PEA-PME). For more information, visit www.mediantetechnologies.com.
Forward-Looking Statements
This press release contains forward-looking statements. These statements are not historical facts. They include projections and estimates, and the assumptions on which they are based, statements regarding plans, objectives, intentions and expectations regarding future financial results, events, operations, services, product development and potential, or future performance.
Such 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 such 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, or implied or projected by the forward-looking information and statements.
All forward-looking statements contained 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 Regulations of the French Autorité des Marchés Financiers.
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1 The accuracy of a diagnostic test is determined by the ratio of true positives to false positives. To calculate the ratio, medical professionals use what is called the receiver operating characteristic (ROC) to generate a statistical graph or curve; the area under the curve (AUC) measures diagnostic accuracy and can be used to compare different screening methodologies. For reference, a diagnostic test with no discriminatory power (for example, distinguishing cancerous tissue from normal tissue) would have an AUC of 0.5 while a perfect test would have an AUC of 1.
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