Press release – For immediate release – 5:45 pm CEST
Median Technologies announces onboarding of all academic sites involved in the pivotal validation plan for iBiopsy® LCS CADe/CADx SaMD
- 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.
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):
- 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.
- 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 cancer. 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.