Klinisk prövning av loopborst-assisterad finnålsaspiration av pankreascystor

Important results from the project

The project resulted in the Loop Brush Fine-Needle Aspiration device produced under Good Manufacturing Practices and ready to be tested in patients for the first time. The ethical application for the trial is currently under review (CIV-25-03-051742 - PCLoop-Pilot) and will start by the beginning of 2026. The company Lucky Loop Medical AB has been created and has raised approximately 2 MSEK from a VC company. Several Fortune 500 companies have showed interest in the product developed.

Expected long term effects

While the product developed is a small change to the current medical praxis, it finally provides a solution to the early diagnosis of pancreatic cysts and may reach savings of 1.8 BSEK in Sweden alone. Since the product allows early access to cells, personalized treatments such as the personalized RNA neoantigen vaccines can even cure pancreatic cancer. With this product, the lives of millions of patients could be directly impacted, and this cancer´s survival rate can be significantly improved.

Approach and implementation

In the project, Loop Brush Fine-Needle Aspiration units have been produced by KTH in collaboration with Cenova - a certified manufacturer of advanced medical devices. The product has been produced under the so-called GMP protocol and sterilized for use in humans. In parallel, KTH and Region Västerbotten have prepared for a first clinical study in humans to begin spring 2026. During the the project, the design has been optimized for manufacturing and the product has been tested regulatorily.