Dear Innitius Community,
We’re happy to share an important milestone in our journey to improve obstetric care. The Spanish Agency of Medicines and Medical Devices (AEMPS) has officially approved the launch of our pivotal clinical study for CerviSense TPTL, our diagnostic tool for assessing women with symptoms of threatened preterm labor (TPTL).
This is a major step forward as we continue building the evidence needed to bring CerviSense to clinical practice.
This marks a critical step forward in bringing a more accurate, non-invasive, and real-time solution to a clinical area where misdiagnosis remains far too common. We believe this study will help set a new standard in maternal care.
Clinical Study Overview
The study, titled “Evaluation of the safety and the preterm birth predictive capacity of the clinical investigation device ‘CerviSense TPTL’: an international clinical study,” will enroll 457 patients across hospitals in Spain and Germany.
It will take place in two phases:
- Pilot Phase
This phase launched in April and is currently active in four Spanish hospitals. It is a randomized, open-label study with a recruitment period of approximately six months. - Pivotal Phase
Set to begin after the pilot, this phase will expand to 14 hospitals in Spain and 3 hospitals in Germany by the end of 2025. It will be conducted as a single-arm, open-label study running for approximately 14 months.
Both phases will be carried out as part of the standard of care in participating hospitals.
Why This Matters
Each year, thousands of women are hospitalized with symptoms of preterm labor, yet current diagnostic tools are often unreliable. As a result, many receive unnecessary treatments or, worse, are sent home without adequate intervention.
CerviSense aims to change that. By measuring cervical consistency through torsional wave technology, the device provides an objective, real-time indicator of whether labor is truly imminent. This has the potential to:
- Reduce unnecessary hospital admissions and interventions
- Improve outcomes for mothers and babies
- Empower clinicians with clearer, data-driven insights
About CerviSense
CerviSense TPTL uses torsional wave technology to measure the mechanical consistency of cervical tissue. This approach provides clear, real-time data that can help identify women at risk of preterm birth earlier and more accurately than current methods.
Participating Spanish Hospitals
We’re proud to collaborate with the following hospitals for this important research:
- H. Universitario San Cecilio H. Universitario de Basurto H. Universitario de Cruces H. Universitario de Torrejón H. Clínic de Barcelona
- H. Sant Joan de Déu
- H. Vall d’Hebron
- H. Virgen Arrixaca
- H. Universitario La Paz
- H. Universitario de Málaga
- H. Universitario de A Coruña
- H. General Universitario Gregorio Marañón H. Universitario de Donostia
- H. Materno Infantil de Gran Canaria
We are also working with German regulators to finalize participation from three leading hospitals in Germany.
Looking Ahead
This study will provide key clinical evidence on the safety and predictive performance of CerviSense TPTL. It brings us one step closer to offering physicians and patients a more reliable tool to support timely decision-making in threatened preterm labor.