Pregnolia – Pregnolia Dx
The Problem
Preterm birth remains one of the greatest unresolved challenges in modern obstetrics. Affecting 13.4 million babies each year, it is the leading cause of infant mortality worldwide and accounts for more than €22 billion in annual healthcare costs in Europe alone.
Despite advances in prenatal care, current diagnostic tools, including cervical length ultrasound and biochemical biomarkers, lack sufficient predictive accuracy. As a result, many women are unnecessarily hospitalised and treated, while others at genuine risk of imminent preterm delivery are discharged too early. This diagnostic gap continues to place mothers, babies, and healthcare systems under significant strain.
The Project
Pregnolia AG, a Swiss medical technology company, has developed Pregnolia Dx, a breakthrough diagnostic platform that measures cervical stiffness — a novel and earlier biomarker of preterm birth risk.
By combining a CE-marked medical device with a proprietary risk prediction algorithm, Pregnolia Dx provides objective, quantitative results within minutes. The system detects cervical changes earlier than traditional methods and significantly outperforms the current gold standard in predictive accuracy.
The Impact
With strategic support from Evolution Europe, Pregnolia successfully secured EIC Accelerator blended finance to conduct a large multicentre clinical validation trial, complete MDR certification of its software, and prepare for commercial scale-up.
The technology enables earlier and more precise intervention, reduces false positives and false negatives, lowers neonatal complications, and has the potential to generate savings of more than €500 million annually across Europe and the United States.
The Result
As a result of this successful application, Pregnolia AG secured EIC Accelerator blended finance consisting of a €2.2 million grant and a €5 million equity investment request.
This funding represents a major milestone for the company and positions Pregnolia Dx to help establish a new global standard in precision prenatal diagnostics.
Success story video
