- Primary endpoint met with statistical significance (p=0.027) in
pivotal RELIVE trial of eyonis™ LCS, Median’s AI/ML-based Software
as a Medical Device for lung cancer screening
- eyonis™ LCS has now successfully completed its clinical
validation, having already met primary and all secondary endpoints
in previous pivotal study, REALITY
- eyonis™ LCS filings for U.S. FDA 510(k) clearance and EU CE
marking submission targeted for Q2 2025
- eyonis™ LCS FDA clearance is expected as early as Q3, 2025,
with subsequent commercial launch in U.S.
Regulatory News:
Median Technologies (Paris:ALMDT):
Fredrik Brag, CEO of Median Technologies, will
host two webcasts on February 4, 2025 “New Horizons in Fighting
Lung Cancer: eyonis™ LCS RELIVE study results and next steps
towards marketing authorizations”
- February 4, 2025 – 2:00 pm CET (French): Sign-up Link
- February 4, 2025 – 4:00 pm CET / 10:00 am EDT (English):
Sign-up Link
Webcast replays will be available on Median’s
corporate website shortly after the live sessions.
Median Technologies (FR0011049824, ALMDT, PEA/PME scheme
eligible, “Median” or “The Company”) announces today that eyonis™
LCS, its wholly owned proprietary AI/ML-based CADe/CADx Software as
a Medical Device (SaMD) for lung cancer screening, met the primary
endpoint in RELIVE. Top-line data from RELIVE shows that eyonis™
LCS together with radiologist achieved statistically significant
improvement over radiologist alone (p=0.027). RELIVE is the second
of two pivotal studies required for marketing authorization in U.S.
and Europe.
By meeting primary endpoint in RELIVE, eyonis™ LCS has
successfully completed its clinical validation and confirmed the
analytical validation previously achieved in REALITY, a standalone
pivotal study which results were announced in August 2024.
Successful pivotal studies are a key prerequisite of regulatory
submissions both in the US and in EU. Consequently, eyonis™ LCS
regulatory filings are now being prepared for U.S. FDA 510(k)
filing and EU CE marking and will be submitted in Q2 2025.
Median’s eyonis™ LCS AI/ML-based CADe/CADx SaMD is designed to
improve diagnostic accuracy of radiologists in analyzing low dose
computed tomography (LDCT) scans for lung cancer screening.
Lung cancer is the number one killer of all cancers. A recent
study showed that only 16% of lung cancers are diagnosed at an
early stage and, because most were detected too late, the average
five-year survival rate for all lung cancer patients is 18.6%1.
Conversely, Stage 1 lung cancer can be cured, with an 80% survival
rate after 20 years. For Stage 1A cancers that measure 10 mm or
less, the 20-year survival rate has been shown to reach 92%.
“This is truly the most important milestone that Median eyonis™
has achieved yet; with RELIVE successfully meeting primary
endpoint, we confirm the game-changing potential of our AI/ML-based
Software as a Medical Device for lung cancer screening. We are
confident that eyonis™ LCS will contribute to accelerate efforts in
the U.S. and Europe by making lung cancer screening more accurate
and efficient, especially for early-stage lung cancers” said
Fredrik Brag, CEO and Founder of Median Technologies. “Broad
implementation of LDCT screening procedures with eyonis™ LCS has
the potential to dramatically improve lung cancer diagnosis
accuracy, address the bottlenecks of complexity and time required
for analyzing LDCT images, and, most importantly, save lives and
reduce the need for healthcare spending on late-stage lung cancer
treatment.
“We believe timely screening of the high-risk populations using
eyonis™ LCS can enable doctors to save more lives while further
reducing medical costs,” Brag continued. “Furthermore, using
eyonis™ LCS can not only save lives but also prevent healthy
patients from undergoing unnecessary medical procedures. This will
avoid unnecessary distress for patients and afford payers
tremendous cost savings on unnecessary procedures in addition to
obviating the even greater costs of palliative care required for
late- stage lung cancer management.”.
The primary objective of RELIVE, a multi-reader multi-case
(MRMC) trial conducted on a cohort of 480 patients at high-risk of
developing lung cancer, was to demonstrate, through a superiority
test run by a set of 16 radiologists, that eyonis™ LCS can improve
clinicians’ diagnostic accuracy in analyzing LDCT lung cancer
screening scans, by helping in the detection localization and
characterization of lung nodules, by reducing false positives and
by driving clinical management to avoid unnecessary follow-up
procedures. Top-line data from RELIVE shows that eyonis™ LCS
achieved statistically significant improvement over radiologist
alone (p=0.027). This finding demonstrates that eyonis™ LCS may
save lives of patients, time for healthcare professionals as well
as reduce cancer costs for payers.
Additional RELIVE data, including multiple secondary endpoints,
are being analyzed and will be reported in the coming weeks. RELIVE
data will be shared in future Median Technologies communications
and at upcoming medical and scientific conferences. More
information regarding RELIVE study can already be found on
ClinicalTrials.gov, study ID NCT06751576.
The first pivotal study, REALITY, initially communicated in
August 2024, collected retrospective imaging and clinical data from
1,147 patients. REALITY evaluated eyonis™ LCS’ ability to diagnose
and characterize cancerous vs non-cancerous patients (i.e.
“performance at patient level”), and detect and characterize
suspicious versus malignant nodules using LDCT lung screening
scans.
Both RELIVE and REALITY studies were performed using
retrospectively collected imaging and clinical data from patients
from five major cancer centers and hospitals in the US and in EU,
along with two US data providers.
About lung cancer screening in the U.S.: Lung cancer
screening is recommended by the U.S. Preventive Services Task Force
(USPTF) in adults aged 50 to 80 years who have a 20 pack-year
smoking history and covered by Medicare; the eligible population is
currently of 14.5 million people.
There already is an existing reimbursement of $650 per SaMD
procedure creating a substantial commercial opportunity to improve
patient care in this addressable market. Furthermore, the eligible
patient number is expected to rise in the coming years, driven by
planned broadening of the eligible U.S. population by USPTF.
Similarly, new lung screening program deployments are planned in
Europe and Asia.
About eyonis™ LCS: eyonis™ Lung Cancer Screening (LCS) is
an artificial intelligence AI/ML-enabled Software as a Medical
Device that uses machine learning to help analyze imaging data
generated with low dose computed tomography (LDCT) to aid to
diagnose lung cancer at the earliest stages, when it can still be
cured in many patients. eyonis™ LCS is the subject of two pivotal
studies required for marketing approvals in the U.S. and Europe:
REALITY (successfully completed - Clinicaltrials.gov ID: NCT0657623
) and RELIVE (primary endpoint successfully achieved, secondary
endpoints analysis on-going - Clinicaltrials.gov ID: NCT06751576).
Filing applications including these pivotal data are scheduled to
be submitted for FDA 510(k) clearance and CE marking in Q2
2025.
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, including the risks set forth in the annual financial
report of the Company published on April 25, 2024, which is
available on the Company's website
(https://mediantechnologies.com/). The occurrence of all or parts
of such risks 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
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/20250202966747/en/
Median Technologies Emmanuelle Leygues VP, Corporate
Marketing & Financial Communications +33 6 10 93 58 88
emmanuelle.leygues@mediantechnologies.com
Investors – SEITOSEI ACTIFIN Ghislaine Gasparetto +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 - ALIZE RP Caroline Carmagnol +33 6 64 18 99 59
median@alizerp.com
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