Webinar to focus on the eyonis™ Lung Cancer
Screening (LCS) REALITY data November 7, 2024 – 1:30 pm CET / 7:30
am ET – Registration link
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
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
Webinar link:
signup
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
View source
version on businesswire.com: https://www.businesswire.com/news/home/20241030792314/en/
MEDIAN TECHNOLOGIES Emmanuelle Leygues Head of Corporate
Marketing & Financial Communications +33 6 10 93 58 88
emmanuelle.leygues@mediantechnologies.com
U.S. media & investors Chris Maggos COHESION
BUREAU +41 79 367 6254 chris.maggos@cohesionbureau.com
Investors Ghislaine Gasparetto SEITOSEI ACTIFIN +33 6
21 10 49 24 ghislaine.gasparetto@seitosei-actifin.com Press
Caroline Carmagnol ALIZE RP +33 6 64 18 99 59
median@alizerp.com
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