Median Technologies Announces Onboarding of All Academic Sites Involved in the Pivotal Validation Plan for iBiopsy® LCS CADe/CADx SaMD
17 Juli 2023 - 5:45PM
Business Wire
- Kick-off meetings have taken place in all academic sites that
will be participating in the pivotal validation plan towards
regulatory approvals of iBiopsy® LCS CADe/CADx SaMD.
- World-class academic healthcare institutions based in the
United States and Europe will be involved in the pivotal validation
plan.
- Median Technologies aims to obtain marketing authorizations of
iBiopsy® LCS CADe/CADx SaMD on the US and European markets, in
2024.
Regulatory News:
Median Technologies (ALMDT) announces today that the Company has
officially commenced operations with all investigator sites
participating in the pivotal validation plan for its iBiopsy® Lung
Cancer Screening (LCS) AI/ML tech-based CADe/CADx Software as
Medical Device (SaMD). For the purposes of its pivotal validation
plan, Median Technologies has signed clinical research agreements
with world-class academic healthcare institutions, which are
leading healthcare centers for the management of lung cancer
patients.
Median’s pivotal validation plan is composed of a pivotal
standalone performance study (MT-LCS-002) and an international
Multi-Reader Multi-Case (MRMC) pivotal clinical trial (MT-LCS-004).
Both pivotal standalone study (MT-LCS-002) and pivotal clinical
trial (MT-LCS-004) results will be respectively submitted to the
FDA for obtaining the 510(k) clearance and to a European notified
body for obtaining CE Marking.
The pivotal validation plan will mainly rely on the
contributions from the sites listed below (by institution
size):
US-based sites:
- The University of Texas MD Anderson Cancer Center, Houston, TX,
USA,
- Hospital of the University of Pennsylvania (Penn Medicine),
Philadelphia, PA, USA,
- Baptist Memorial Health Care and Baptist Clinical Research
Institute, based in Memphis, TN, USA.
Europe-based sites:
- Clínica Universidad de Navarra, Departments of Respiratory
Medicine and Radiology, Pamplona and Madrid, Spain,
- Instituto de Investigación Sanitaria de la Fundación Jiménez
Díaz (IIS-FJD), Madrid, Spain.
“We are privileged and honored to have the opportunity to work
together with these world-class academic healthcare institutions
towards the validation and regulatory approval of our iBiopsy® LCS
CADe/CADx SaMD. Both the large volume of lung cancer patients
managed by these healthcare centers of excellence, as well as their
world-class reputation are key to guarantee the quality of the
imaging and clinical data we will be using in our pivotal
validation plan. Data quality is compulsory for the proper conduct
of our pivotal validation plan” said Fredrik Brag, CEO and Founder
of Median Technologies. “We started contracting with some of these
academic sites during the year 2022, and started receiving data at
the end of last year. Now that we have onboarded all the sites, we
are on track for the launch of our iBiopsy® LCS CADe/CADx SaMD
pivotal validation plan. We will carry out the pivotal standalone
study and pivotal clinical trial according to the protocols
discussed with the FDA during the Q-submission phase, which ended
in February 2023,” Brag added.
The international MRMC pivotal clinical trial Lead Principal
Investigator will be Anil Vachani, MD, the director of Clinical
Research for the Section of Interventional Pulmonary and Thoracic
Oncology at Penn Medicine, and an associate professor of Pulmonary
Medicine in the Perelman School of Medicine at University of
Pennsylvania.
“Cutting-edge AI/ML tech-based Software as Medical Devices are
paving the way for innovation in the field of lung cancer
screening,” Vachani said. “The integration of these devices in
evaluating low-dose CT scans shows considerable potential to
improve the identification of abnormal findings, that if proven in
clinical trials, could lead to improved diagnosis of lung
cancer.”
Lung cancer has the highest mortality rate among all types of
cancer worldwide. In 2020, approximately 1.8 million individuals
died from lung cancer1. Early detection and diagnosis of the
disease, when lung nodules are small and manageable plays a crucial
role in drastically increasing the patient’s 5-year and 15-year
overall survival rates. In the US, the Centers for Medicare and
Medicaid Services (CMS) have provided reimbursement for Low Dose
Computed Tomography (LDCT) lung cancer screening since 2015 and the
target population for lung cancer screening is about 14.5M people.
Similarly, in Europe, more than 20 million individuals meet the
eligibility criteria for lung cancer screening.
About iBiopsy®: Biopsy® is based on the most advanced
technologies in Artificial Intelligence (AI) and Data Science (DS),
benefiting from Median’s expertise in medical image processing.
iBiopsy® targets the development of AI/ML tech-based Software as
Medical Devices (SaMD), to be used in several indications for which
there are unmet needs regarding early diagnosis, prognosis and
treatment selection in the context of precision medicine. iBiopsy®
currently focuses on Lung Cancer, Liver Cancer (HCC) and Liver
Disease (NAFLD/NASH).
About Median Technologies: Median Technologies provides
innovative imaging solutions and services to advance healthcare for
everyone. We harness the power of medical images by using the most
advanced Artificial Intelligence technologies, to increase the
accuracy of diagnosis and treatment of many cancers and other
metabolic diseases at their earliest stages and provide insights
into novel therapies for patients. Our iCRO solutions for medical
image analysis and management in oncology trials and iBiopsy®, our
AI-powered imaging platform for the development of software as
medical devices (SaMD) help biopharmaceutical companies and
clinicians to bring new treatments and diagnose patients earlier
and more accurately. This is how we are helping to create a
healthier world.
Founded in 2002, based in Sophia-Antipolis, France, with a
subsidiary in the US and another one in Shanghai, Median has
received the label “Innovative company” by the BPI and is listed on
Euronext Growth market (Paris). FR0011049824– ticker: ALMDT. Median
is eligible for the French SME equity savings plan scheme
(PEA-PME). For more information: www.mediantechnologies.com
1 Global Cancer Observatory 2022 (GLOBOCAN)
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Median Technologies Emmanuelle Leygues Head of Corporate
Marketing & Financial Communications +33 6 10 93 58 88
emmanuelle.leygues@mediantechnologies.com
Press - ALIZE RP Caroline Carmagnol +33 6 64 18 99 59
median@alizerp.com
Investors - ACTIFIN Ghislaine Gasparetto +33 6 21 10 49
24 ggasparetto@actifin.fr
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