July 16, 2024 -- Positrigo, a Swiss based company developing nuclear medical imaging devices to advance functional brain imaging, has achieved a significant milestone with the U.S. Food and Drug Administration (FDA) with the clearance of its dedicated brain PET system NeuroLF®. This innovative imaging device is ultra-compact and assists in diagnosing and monitoring of brain related disorders like Alzheimer’s disease, Brain Tumors, Epilepsy, Parkinson’s disease and others.

“It is not the first device of its kind which receives market clearance in the US but we believe that our patient-centric and customer-driven design and development efforts over the last couple of years, brought us into the pole position to offer the best imaging solution to address the increased demand of brain PET scans,” says Dr. Jannis Fischer, co-founder and CEO. “We are excited to fulfill numerous pre orders in the US and to have first customers benefiting from our technology very soon. It is incredibly rewarding and I couldn’t be prouder of our team which worked tirelessly to achieve this important milestone.”

The NeuroLF system supports a paradigm shift in medical imaging where a dedicated device allows for imaging of a particular body part or organ. What is well established in cardiac (heart) imaging is just starting now for the brain also. By harnessing the advancement in mechanical, electronic and software developments, this system requires only minimal space and no special room modifications, allows patients to receive a brain scan in a seated position and enables functional imaging at the point-of-care.

Increased Demand for Brain PET in the US
The development of a dedicated brain PET device is very timely as just earlier this month another disease-modifying therapy for Alzheimer’s disease received FDA approval1. This is already the third medication after two other therapies came to market last year in the US2. AD is the most common form of dementia, accounting for ~70% of all dementias in those over 60. In 2020 there were over 55 million people worldwide living with dementia and it is predicted that individuals affected by AD will grow to 139 million in 20503. The early diagnosis is of utmost importance and PET imaging of the brain is essential for the accurate diagnosis of AD patients. However, the currently available PET scanners are large and always combined with MRI or CT. The purchase and maintenance costs are significant and in addition a lot of space is required which limits the availability of these devices.

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