Innitius and the EIC Accelerator: Reading the Cervix to Time Birth

Innitius, trading name of Ultrasound-Innovation Medtech S.L. and led by CEO and co-founder Rubén Molina, develops CerviSense, formerly FineBirth, a probe that measures the consistency of the cervix with torsional waves and uses AI to judge the risk of preterm birth. Its EIC application said threatened preterm labour affects 45 million pregnancies a year and that current methods "are ineffective at detecting true events", and asked for €2.5 million "to fully develop and validate our AI software, do a multicentre pivotal clinical trial, and obtain regulatory approval", according to CORDIS.

The European Innovation Council granted €2,342,836 towards a €3.35 million project from April 2023 to March 2026. The only published report, for the first year, lists an FDA pre-submission, a preliminary health technology assessment, a beta device design that still needed "additional iteration", research into a second use in labour induction, and a pivotal trial design sent to the FDA. In June 2025 Innitius announced that Spain's medicines agency had approved the CerviSense pivotal study: 457 patients in hospitals in Spain and Germany, with a pilot phase started in April 2025 and a pivotal phase of about 14 months to follow.

Where Innitius Stands Now

The CerviSense product page describes the device as "CE-certified" and presents one probe with AI models for three uses across pregnancy. In its 2024 review, Innitius said it had moved from a single product to a platform, manufactured and validated the first eight probes of a new design, and completed its first clinical trial, "surpassing our targets for sensitivity (70%) and specificity (90%)", and that a trial at King's College on preterm labour prognosis would start in early 2025. It has not published the pivotal study's results or announced sales.

The Technology: Measuring Softness, Not Length

Before birth the cervix softens and shortens. Doctors judge softness by touch or measure length by ultrasound; Innitius says 85% of women hospitalised for threatened preterm labour turn out not to be in true labour. CerviSense sends torsional waves into cervical tissue to measure its consistency objectively, and an AI model combines the result with the patient's history to give a risk assessment.

What the EIC Project Promised, and What CORDIS Shows

The project promised AI validation, a pivotal trial and regulatory approval. The first-year report covers planning and design. The pivotal trial started during the project but, at 14 months for the main phase, extends beyond its end in March 2026. The company says the device is CE-certified, but CORDIS publishes no report on the last two years and no trial results. CORDIS lists the project as closed.

1. Market device designDeliveredNew probes validated.
2. Pivotal trialRunningStarted April 2025.
3. CE markingClaimedPer product page.
4. Validated AI accuracyUnverifiedNo published results.

The Money

Innitius's research is also funded by the regional government of Andalusia, according to acknowledgements in its published studies. No private funding round has been announced, and whether the EIC Fund invested under the blended award is not public. Revenue is not public.

What Cannot Be Checked

Why Europe Should Care

Many women with preterm labour symptoms receive unnecessary treatment, while others are sent home without adequate care, Innitius says. An objective test would improve care and save money. The EIC funded Innitius's path to a pivotal trial in European hospitals; the evidence is being gathered now.

The Verdict

Innitius and the EIC have not been asked for comment for this article. It is based entirely on public records and published statements, linked throughout.