Funding clinical validation

We are seeking €1.1 million in funding to support the clinical validation for CE certification pathway of our innovative in vitro diagnostic device for prostate cancer.

The objective of the clinical study is to recruit 600 men undergoing multiparametric MRI (mpMRI) for suspected prostate cancer in 3 hospitals. From this cohort, we expect approximately 350 patients to proceed to prostate biopsy, with an estimated outcome distribution of 50% diagnosed with prostate cancer and 50% without malignancy. This design will allow robust assessment of the diagnostic performance of our test in a clinically relevant population.

The requested funding will be allocated as follows: €244k for clinical study execution, €95k for regulatory activities, €154k for administrative costs, €175k for pre-marketing activities, and €560k for personnel. This investment will enable us to complete validation, achieve CE marking, and prepare for market entry.