Innitius, backed by Seed Capital Bizkaia, advances innovation in the assessment of preterm birth

The Biscay-based company Innitius, backed by Seed Capital Bizkaia, has received authorization from the Spanish Agency of Medicines and Medical Devices (AEMPS) to launch the international phase of a clinical study that will assess the safety and predictive capability of the CerviSense® TPTL device for the diagnosis of preterm birth.

This new study forms part of the FineBirth programme (funded by the European Innovation Council (EIC) Accelerator of the European Union) and represents a key milestone in the process of obtaining CE marking and the future clinical adoption of the device in Europe.

Following the success of a pilot study conducted on a sample of 100 patients, which exceeded its clinical objectives in just one quarter of the expected timeframe, the new trial will include 357 patients in hospitals across Spain and Germany, under real-world clinical conditions, to validate the device’s effectiveness and reliability.

CerviSense® TPTL: an innovation for assessing the risk of preterm birth

The innovative technology developed by Innitius, CerviSense® TPTL, enables a rapid assessment of the risk of spontaneous preterm birth in pregnant women presenting symptoms of imminent preterm labor. To achieve this, the device combines tissue elasticity measurement with the development of artificial intelligence models, delivering accurate, real-time diagnostics that support healthcare professionals in clinical decision-making during labor 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 we expand the programme at an international level.”

Seed Capital Bizkaia Fund I, supporting cutting-edge innovation

Seed Capital Bizkaia, through Fund I, is an investor in this innovative project developed by Innitius.

Fund I is one of the financing instruments offered by Seed Capital Bizkaia to support innovative entrepreneurial initiatives that are at the early stages of development.