European Regulators Approve Positrigo’s Brain PET System

Positrigo has won CE Mark approval for NeuroLF, its dedicated brain Positron Emission Tomography (PET) system. The imaging device is ultra-compact and helps clinicians diagnose and monitor brain-related disorders like Alzheimer’s disease, brain tumors, epilepsy, Parkinson’s disease, and others.

“The CE mark of the NeuroLF system is another important milestone in the development of this dedicated brain PET system and represents a significant advance in the availability of brain PET imaging, allowing nuclear medicine physicians in Europe to offer a dedicated imaging modality to diagnose and monitor patients with brain related disorders,” said Prof. Dr. med. Osama Sabri, director and chairman of the Department of Nuclear Medicine at the University of Leipzig Medical Center.

The NeuroLF system is significantly smaller and more affordable compared to the currently available clinical hybrid PET systems with a much larger footprint and weight and always combined with either magnetic resonance imaging or computed tomography, according to Positrigo. 

Increased Demand for Brain PET in Europe

The European Association of Nuclear Medicine (EANM) Neuroimaging Committee believes that amyloid PET is now at a historical turning point, where it has helped foster early AD diagnosis solutions. These experts expect that amyloid PET will be more widely used in the near future to justify the initiation and to monitor the effect of disease-modifying therapies on biological grounds.¹ The Nuclear Medicine community should therefore be prepared to adjust its capacities to the increased demand for amyloid PET radiotracers, PET imaging infrastructure, and training for image reading and reporting in the near future. According to some estimates, the need for amyloid PET may increase by a factor of 20.²

“At Positrigo, we seek to push the limits by developing and commercializing new types of medical imaging technologies,” Positrigo Co-Founder/CEO Dr. Jannis Fischer stated. “The CE mark of the NeuroLF system is testament to this, now offering healthcare professionals the potential to improve the diagnosis for people living with brain related disorders like Alzheimer’s disease (AD) while setting a new standard in brain PET imaging.”

European Commercialization With Selected Partners

Positrigo plans to sell its technology in Europe by leveraging a network of established companies in selected countries. “Due to the fragmented healthcare system in Europe with different country-specific purchase mechanisms and healthcare reimbursement systems, it is most efficient to partner with local companies in selected countries,” Positrigo Chief Commercial Officer Dr. Stefan Bircher explained. “This way we [can] achieve fast commercial traction and hope to offer best-in-class after sales support at the same time”.

The NeuroLF system is the first device of its kind to receive market clearance in Europe and the United States, according to the company.

Headquartered in Zurich, Switzerland, Positrigo was founded in 2018 as a spin-off of ETH Zurich. Positrigo’s technology, development, clinical testing, and commercialization has been supported by various private investors, the Swiss government and the European Innovation Council. NeuroLF, the company’s first device, is an ultra-compact brain Positron Emission Tomography (PET) scanner that has applications in assessing causes of dementias such as Alzheimer’s disease and other brain-related disorders.

References

¹   FDA approval of lecanemab: the real start of widespread amyloid PET use? — the EANM Neuroimaging Committee perspective | European Journal of Nuclear Medicine and Molecular Imaging (springer.com)

²   The approval of a disease-modifying treatment for Alzheimer’s disease: impact and consequences for the nuclear medicine community | European Journal of Nuclear Medicine and Molecular Imaging (springer.com)