The Biscayan company Innitius, owned by Seed Capital Bizkaia, has received authorisation from the Spanish Agency for Medicines and Health Products (Agencia Española de Medicamentos y Productos Sanitarios – AEMPS) to begin the international phase of a clinical study to evaluate the safety and predictive capacity of the CerviSense ® TPTL device for diagnosing preterm birth.
This new study is part of the FineBirth programme (funded by the European Union’s EIC Accelerator) and represents a crucial milestone toward CE marking and future clinical adoption of the device in Europe.
Following the success of a pilot study with 100 patients that exceeded clinical targets in only a quarter of the expected time, the new trial will include 357 patients across hospitals in Spain and Germany under real-world clinical conditions to validate its efficacy and reliability.
CerviSense® TPTL, an innovation to assess the risk of preterm birth
CerviSense® TPTL, the innovative technology developed by Innitius, enables rapid assessment of the risk of spontaneous preterm delivery in pregnant women presenting symptoms of impending preterm delivery. It combines measurements of tissue elasticity with artificial intelligence models to provide accurate diagnoses in real time, supporting health professionals in decision-making during labour management.
“This milestone is essential to bringing a precise and easy-to-use tool to market,” said Rubén Molina, CEO and co-founder of Innitius. “It reinforces our commitment to clinical and regulatory robustness while expanding the programme internationally.”
Seed Capital Bizkaia Fund I, supporting cutting-edge innovation
With Fondo I, Seed Capital Bizkaia participates in Innitius’ innovative project.
Fondo I is one of the financing tools offered by Seed Capital Bizkaia to support innovative business initiatives that are in the early stages of development.
