A French subtitled replay will be made available a few days afterwards on Median Website
SOPHIA-ANTIPOLIS, France, November 07, 2024--(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) candidates for early cancer diagnostics, and a globally leading provider of AI analyses and imaging services for oncology drug developers, today announced that it hosted a successful event with two key opinion leaders (KOLs) in the field of pulmonology.
Approximately 80 institutional investors, individual shareholders, analysts, journalists and other stakeholders attended the November 7 event. 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, provided their views on the data from REALITY, Median’s recently completed pivotal study of the eyonis? LCS SaMD, and how the AI powered device may impact lung cancer diagnostics and treatment. The data from REALITY will be included in filings for marketing authorizations in the US and in Europe in H1 2025. Fredrik Brag, CEO and founder of Median Technologies, presented results from the study at the event.
"We are proud to have welcomed Prof. Vachani and Prof. Zulueta, two globally recognized experts in pulmonology, to Median’s event on our eyonis? LCS diagnostic candidate. The REALITY study has shown that the AI-powered eyonis? LCS device has considerable potential to address the urgent need for greater accuracy and efficiency to increase early detection of lung cancer. We discussed the urgent need to support radiologists in navigating complex and often inconclusive imaging data in order to roll out lung cancer screening to all those who can benefit. The REALITY study data suggest that eyonis? LCS may well be a game changer by significantly improving early diagnosis, allowing for earlier intervention and broadening screening access—a critical step toward global implementation of these lifesaving programs. Based on our strong data, we are now looking towards our filings for marketing authorization, in both the US and Europe, in H1 2025, as soon as we receive and report the data from RELIVE, our second pivotal study," said Fredrik Brag.
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 still 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, like biopsies, to investigate inconclusive diagnostic imaging data presents moral, ethical and financial burdens for doctors, patients and payers.
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, where many of the subjects died from other causes. Stage 1A cancers that measure 10 mm or less have been shown to have a 20-year survival rate of 90%.
Details of the KOL webinar:
A replay of the webinar in English, including a subsequent Q&A session with the participants, is available here. A French subtitled version will be made available a few days afterwards on Median website as well.
Title:
The eyonis? Lung Cancer Screening (LCS) REALITY data - What leading U.S. clinical pulmonology experts are saying
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
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
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 a 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 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.
Forward-Looking Statements
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