- eyonis™ LCS met the primary endpoint for accuracy, achieving an
Area Under the Curve (AUC)1 of 0.90, significantly above the 0.80
set for regulatory clearance.
- eyonis™ LCS met all 9 secondary endpoints in REALITY with
statistical significance.
- RELIVE, the second eyonis™ LCS pivotal study, to report
top-line data in Q1 2025.
- U.S. & European eyonis™ LCS marketing authorization
regulatory filings in H1 2025.
Regulatory News:
Median Technologies (FR0011049824, ALMDT, PEA/PME scheme
eligible, “Median” or “The Company”) announces today that eyonis™
LCS, its proprietary Artificial Intelligence (AI)/machine learning
(ML) powered Software as Medical Device (SaMD) for lung cancer
screening (LCS), met the primary and all secondary endpoints in
REALITY, the first of two pivotal studies required for marketing
authorizations in U.S. and Europe.
Median’s eyonis™ LCS SaMD is designed for improving the
detection and diagnostic accuracy of low-dose computed tomography
(LDCT). LDCT imaging is the standard of care globally and is
currently the only approved lung cancer screening modality in U.S.
and Europe.
Fredrik Brag, CEO of Median Technologies said: “These
data met our ambition for improving the performance of LDCT with
eyonis™ LCS. Now, we are even more excited to report the upcoming
RELIVE pivotal data and file for marketing authorizations in H1
2025. We believe that broad implementation of LDCT with eyonis™ LCS
has the potential to vastly improve early detection and lead to far
more cures, dramatically reducing lung cancer mortality.”
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%.
Consequently, there is tremendous momentum behind efforts in the
U.S., Europe and Asia to increase lung cancer screening and improve
its accuracy. Enabling the accurate early detection of lung cancer
with eyonis™ LCS could dramatically improve lung cancer
survival.
Thomas Bonnefont, COO and CCO eyonis™ Business Unit said: “The
high performances of our device can not only save lives but also
prevent healthy patients undergoing unnecessary medical procedures.
This will avoid unnecessary distress for patients and reduce
healthcare costs.”
Lung cancer screening is recommended by the U.S. Preventive
Services Task Force (USPSTF) in adults aged 50 to 80 years who have
a 20 pack-year smoking history. The market opportunity includes a
population of 14.5 million people in the US alone, currently
eligible for a lung cancer screening exam, with an existing
potential reimbursement of $650 per exam with a SaMD postprocessing
for characterization of malignant vs benign nodules. This
represents a total addressable annual market of over $9 billion.
The eligible U.S. patient number is expected to rise in the coming
years, driven by planned broadening of the eligibility criteria.
Similarly, new lung screening program deployments are planned in
Europe and Asia. Around $230bn were spent on cancer medical care in
2023 in the US. The vast majority of cancer care costs are incurred
in treating advanced cancer patients, versus preventive care such
as screening that can save patients’ life.
Definitive results from REALITY show that eyonis™ LCS can
accurately detect and characterize cancerous nodules. The novel
SaMD achieved exceptional results, with an area under the curve
(AUC) value of 0.904 at patient level versus an AUC of 0.80 – the
minimum value set as a primary endpoint for REALITY. 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 pivotal REALITY study (Clinicaltrials.gov identifier:
NCT0657623), initiated in July 2023, collected retrospective
imaging and clinical data from 1,147 patients from five major
cancer centers and hospitals in the US and Europe and two clinical
data providers. REALITY evaluated eyonis™ LCS ability to diagnose
lung cancer. The objectives were to assess eyonis™ LCS standalone
performance in characterizing cancerous vs non-cancerous patients
(i.e. “performance at patient level”), and in detecting and
characterizing suspicious versus malignant nodules. The primary
endpoint of REALITY was determined after consultation with the U.S.
regulatory authorities and the primary endpoint was selected to
show that eyonis™ LCS would achieve an AUC superior to 0.8.
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 and
communicated today with REALITY. All the patient recruitment and
relevant patient clinical data for the RELIVE study have already
successfully been collected from the participating sites. RELIVE is
scheduled for completion in the coming months, with an anticipated
data read-out in Q1 2025 and regulatory filings in H1 2025.
About eyonis™ LCS: eyonis™ Lung Cancer Screening (LCS) is
an artificial intelligence (AI) powered diagnostic tool that uses
machine learning (ML) to help analyze imaging data generated with
low-dose computational tomography (LDCT) to diagnose 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 - Clinicaltrials.gov
identifier: NCT0657623) and RELIVE (ongoing). Filing applications
including these pivotal data are scheduled to be submitted for FDA
510(k) premarket clearance and CE marking in H1 2025. In the
interim, eyonis™ technology is being used in at clinical research
centers. Separately, Median’s AI technology is being sold and
deployed via Median’s iCRO business unit, to biopharmaceutical
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.
Median Technologies’ 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/20240829701472/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
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