(San Diego, CA, USA, from September 7-10,
2024)
- eyonis™ LCS is a proprietary Software as Medical Device (SaMD)
powered by artificial intelligence (AI) / machine learning (ML) for
early detection and diagnosis of lung cancer
- eyonis™ LCS achieved unrivaled standalone accuracy (AUC1=0.904)
evaluating low dose computed tomography (LDCT) images, in recently
completed first pivotal study
- Median to report the second eyonis™ LCS pivotal trial top-line
data in Q1 2025
- U.S. and European eyonis™ LCS regulatory filings are scheduled
for H1 2025
- The Median eyonis™ team will share eyonis™ LCS’ latest data and
meet with WCLC attendees at Booth #2601
Regulatory News:
Median Technologies (FR0011049824, ALMDT, PEA/SME eligible,
“Median” or “The Company”) announces today that the Company will be
sharing information on its proprietary AI/ML-powered SaMD, eyonis™
LCS, including recently announced data from the pivotal REALITY
study, at Booth #2601 during the 2024 World Conference on Lung
Cancer (WCLC), being held in San Diego, CA, USA, from September
7-10, 2024. The WCLC, the premier world conference on lung cancer,
is organized by the International Association for the Study of Lung
Cancer (IASLC), a global multidisciplinary association dedicated to
eradication of all forms of lung cancers.
eyonis™ LCS is designed to improving the detection and
diagnostic accuracy of LDCT in lung cancer screening procedures.
LDCT imaging is the standard of diagnostic care globally and is
currently the only approved lung cancer screening modality in U.S.
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 stage2. Conversely, Stage 1 lung cancer
can be cured when detected, with an 80% survival rate after 20
years, where many die from other causes. For Stage 1A cancers that
measure 10 mm or less, the 20-year survival rate has been shown to
be 92%.
The Company released in August the definitive results from the
first of the two pivotal eyonis™ LCS clinical studies, REALITY
(Clinicaltrials.gov identifier: NCT0657623) evaluating the
standalone performance of the medical device in characterizing
cancerous vs non-cancerous patients (i.e. “performance at patient
level”), and in detecting and characterizing suspicious versus
malignant nodules. Despite the inclusion of many challenging LDCT
images, the eyonis™ LCS SaMD achieved exceptional results and met
all study primary and secondary endpoints with statistical
significance and achieved an area under the curve (AUC) value of
0.904 at patient level versus an AUC of 0.80 – the minimum value
set as the primary endpoint for REALITY.
REALITY analyses were conducted on data from a cohort of 1,147
patients from five major cancer centers and hospitals in the US and
Europe and two clinical data providers. Importantly, 80% of the
cancers in the analyzed cohort of REALITY were
difficult-to-diagnose Stage 1 cancers. Moreover, the REALITY cohort
was enriched compared to real life with small non-spiculated
cancers, and large spiculated benign nodules, both of which are
challenging for radiologists to diagnose.
The second pivotal trial, RELIVE, is a Multi-Reader Multi-Case
(MRMC) study that will offer clinical validation of eyonis™ LCS to
complement the analytical validation already achieved with REALITY.
RELIVE is ongoing and scheduled for completion in the coming
months, with an anticipated data read-out in Q1 2025. Median
Technologies expects eyonis™ LCS regulatory filings in the US for
FDA 510(k) clearance and in Europe for CE marking in H1 2025.
With eyonis™ LCS, Median Technologies is working to provide the
U.S. and European lung cancer medical communities with a unique
breakthrough software as medical device to help medical
professionals expedite lung cancer screening programs. Increased
accuracy with eyonis™ LCS can help save lives and reduce the
distress and costs associated with unnecessary procedures.
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 the majority of
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 IASLC 2024 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 over 5,000 leading experts, researchers, and
oncologists gather to showcase cutting-edge advancements in lung
cancer research, treatment modalities, and personalized therapies,
fostering collaboration towards a world free from the burden of
lung cancer. For more information about 2024 WCLC, visit
https://wclc2024.iaslc.org/
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 The accuracy of a diagnostic
test is determined by the balance between true positives and false
positives. To calculate the ratio, medical professionals use what
is referred to as the receiver operating characteristic (ROC) to
generate a statistical plot, or curve; the area under the curve
(AUC) scores the diagnostic accuracy and can be used to compare
different screening methodologies. For reference, a diagnostic test
with no discriminatory power (e.g. to discern cancerous from normal
tissue) would have an AUC of 0.5 while a perfect test would have an
AUC of 1. 2
https://www.mountsinai.org/about/newsroom/2022/lung-cancer-screening-dramatically-increases-long-term-survival-rate
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version on businesswire.com: https://www.businesswire.com/news/home/20240904645829/en/
MEDIAN TECHNOLOGIES Emmanuelle Leygues Head of 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
Median Technologies (EU:ALMDT)
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