A Successful Year for Positrigo
December 30, 2024
Positrigo, a Swiss based company developing nuclear medicine imaging devices to advance functional brain imaging looks back on a successful year with the accomplishment of several critical milestones.
The year started with the successful initiation of a clinical trial at the University of Leipzig Medical Center. The goal of the study was to compare the performance of the NeuroLF System with a conventional PET/CT device. At the European Conference of Clinical Neuroimaging (ECCN), Prof. Dr. med. Henryk Barthel presented first study results and concluded: “After analyzing the first NeuroLF brain images, I am impressed by their quality. The images show non-inferiority compared to conventional PET/CT devices”.
Regulatory Approval in the US and Europe
In July Positrigo achieved a significant milestone with the U.S. Food and Drug Administration (FDA) with the clearance of its dedicated brain PET system. Only a few months later the company announced the MDR approval (CE Mark) which made the NeuroLF system the first device of its kind to obtain regulatory approval in the US and in Europe.
Strong Commercial Traction
The interest in a dedicated brain PET system has been reflected in first sales of the NeuroLF system shortly after receiving commercial approval. The company experienced strong demand in the US thanks to the growing demand of brain PET scans due to the availability of disease-modifying therapies for Alzheimer’s disease. It is expected that this dynamic will be seen very soon in Europe also.
Striving for Operational Excellence
Together with its partners, Positrigo started device production and streamlined delivery, installation and training procedures. The first system was shipped and successfully installed shortly before year end in the US.