- Two globally leading pulmonologists reviewed REALITY data, AI
and the potential impact on lung cancer screening
- Replay in English is available on the link here
- A French subtitled replay will be made available a few days
afterwards on Median Website
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
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/20241107639256/en/
MEDIAN TECHNOLOGIES Emmanuelle Leygues VP, Corporate
Marketing & Financial Communications +33 6 10 93 58 88
emmanuelle.leygues@mediantechnologies.com
Investors Ghislaine Gasparetto SEITOSEI ACTIFIN
+33 6 21 10 49 24 ghislaine.gasparetto@seitosei-actifin.com
U.S. media & investors Chris Maggos COHESION
BUREAU +41 79 367 6254 chris.maggos@cohesionbureau.com
Press Caroline Carmagnol ALIZE RP +33 6 64 18 99
59 median@alizerp.com
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