Point of care diagnostic solution for definitive differentiation of true and false threatened preterm labour cases

Threatened Preterm Labour (TPTL) is the leading cause of preterm births and hospitalization during pregnancy. With 45M cases annually, treatments and resources are not being properly allocated towards the patients who need them. Efficient diagnosis of TPTL is the key to optimizing treatments but, current methods are ineffective at detecting true events.INNITIUS has developed Fine Birth, the first non-invasive PoC diagnostic device that uses torsional waves and AI to directly measure a patient’s cervical tissue consistency to identify the risk of TPTL in real-time. It is objective, accurate, fast and can be operated by staff with minimal training.We have reached TRL6, testing the prototype in a multicentre clinical study with +300 patients in 7 sites. We need €2.5M to fully develop and validate our AI software, do a multicentre pivotal clinical trial, and obtain regulatory approval, which we will be able to finalise with the support of the EIC.