Future Tools for Improved Cancer Surgery: From Prototype to Clinical Use

Important results from the project

The project has been implemented according to plan and all objectives have been achieved. The work has included further development of algorithms and the execution of a second preclinical study. The necessary technical documentation has been compiled and submitted to the Swedish Medical Products Agency with the aim to obtain approval to start a first clinical study on a patient, which moves the company from a preclinical to a clinical stage.

Expected long term effects

The clinical study enables verification of the product´s performance and usability in a clinical setting, with the goal of demonstrating that radical tumor resections can be achieved with support of Navaris´ technology. The study marks the transition from preclinical to clinical stage, which is an important milestone for continued funding of the company. Generated clinical data is both necessary and crucial for regulatory approval and thus for future market introduction.

Approach and implementation

The project has been implemented according to plan in close collaboration with selected development partners. Prioritized activities have led to a first finished version of the company´s product, ready for validation in an upcoming clinical study. The schedule has been largely met, with only minor delays due to external factors, such as supplier delays.