SOPHIA-ANTIPOLIS, France--(BUSINESS WIRE)--Regulatory News:
Median Technologies (FR0011049824, ALMDT, PEA/SME eligible, “Median” or “The Company”), a leading developer of eyonis™, a suite of artificial intelligence (AI) powered Software as a Medical Device (SaMD) for early cancer diagnostics, and a globally leading provider of AI analyses and imaging services for oncology drug developers, today announced that it will host on November 7, 2024 at 1:30 pm CET / 7:30 am ET a KOL webinar to discuss REALITY, the recently completed study of the eyonis™ LCS SaMD for early diagnosis of lung cancer.
Two leading U.S. pulmonology experts Prof. Anil Vachani, from the Hospital of the University of Pennsylvania, and Prof. Javier Zulueta, from the Icahn School of Medicine at Mt Sinai, will share their views on the data from REALITY and how eyonis™ LCS may impact lung cancer early diagnostics.
Final results from REALITY, the first of the two pivotal studies for the eyonis™ LCS SaMD, which will be included in filings for marketing authorizations in the US and in Europe in H1 2025 also will be presented by Fredrik Brag, CEO and founder of Median Technologies.
Large epidemiologic studies conducted in the US and in Europe have shown that Low-Dose Computed Tomography (LDCT) lung cancer screening enables diagnosis of lung cancer at the earliest stage of the disease, when patients can be cured. However, the challenge of interpreting LCS images is a significant burden for medical professionals, especially when diagnostic imaging data are inconclusive, close to the current technological limit of detection. Ordering confirmatory procedures to investigate inconclusive diagnostic imaging data, like biopsies, which are invasive and expose patients to potential risks, presents ethical and financial burdens for doctors, patients and payers.
“Improving diagnosis accuracy and efficiency to facilitate broader adoption of lung cancer screening procedures is an unmet medical challenge that AI technology is well-suited to address. Radiologists can be burdened by LCS data, especially when it’s inconclusive. Our topline REALITY study data reported in August suggest that eyonis™ LCS may well be a game changer, helping doctors accurately detect more lung cancer cases early enough to save lives while also increasing screening capacity to catalyze broad adoption of lung cancer screening programs in the US and elsewhere. We look forward to discussing these data with the globally recognized pulmonology experts,” said Fredrik Brag.
The American Cancer Society’s 2024 US lung cancer estimates predict about 234,580 new cases and 135,070 deaths1. Lung cancer is one of the largest global public health concerns and the leading cause of cancer-related deaths worldwide, with an estimated 1.8 million deaths reported in 20222. Currently, in the US, the average five-year survival rate for all lung cancer patients is only 18.6 percent because just 16 percent of lung cancers are diagnosed at an early stage (i.e. Stage 1)3. But Stage 1 lung cancer can be cured, when diagnosed, with an 80% survival rate over 20 years. Stage 1A cancers that measure 10 mm or less have been shown to have a 20-year survival rate of 90%.
KOL webinar details:
Title: |
The eyonis™ Lung Cancer Screening (LCS) REALITY data - What leading U.S. clinical pulmonology experts are saying |
Date: |
Thursday, November 7, 2024, at 1:30 pm CET / 7:30 am ET. |
Participants: |
Prof. Anil Vachani, MD, Director of Clinical Research, Section of Interventional Pulmonary and Thoracic Oncology and Professor of Medicine (Pulmonary, Allergy and Critical Care) at the Hospital of the University of Pennsylvania and the Veteran's Administration Medical Center, Philadelphia, PA, USA |
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Prof. Javier Zulueta, MD, Senior Faculty and Chief of the Division of Pulmonary, Critical Care and Sleep medicine at Mount Sinai Morningside Hospital, Icahn School of Medicine at Mount Sinai, New York City, NYC, USA |
Fredrik Brag, CEO and Founder of Median Technologies, France |
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Webinar link: |
A Question & Answer session will follow the formal presentation.
Due to the nationality of the speakers, the webinar will be held in English with the replay available on Median’s corporate website after the live session. A French subtitled version will be made available a few days afterwards.
About eyonis™ LCS: eyonis™ Lung Cancer Screening (LCS) is an artificial intelligence (AI) powered diagnostic device that uses machine learning to help analyze imaging data generated with low dose computed tomography (LDCT) to diagnose lung cancer at the earliest stages, when it can still be cured in many 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) and RELIVE (ongoing). Filing applications including these pivotal data are scheduled to be submitted for FDA 510(k) premarket clearance and CE marking in 2025. Separately, Median’s AI technology is being sold and deployed across cancer indications, via Median’s iCRO business unit, to 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 a medical device (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.
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 ACR: https://www.cancer.org/cancer/types/lung-cancer/about/key-statistics.html
2 GLOBOCAN: https://gco.iarc.who.int/media/globocan/factsheets/populations/900-world-fact-sheet.pdf
3 https://press.rsna.org/timssnet/media/pressreleases/14_pr_target.cfm?ID=2464
