Point of care diagnostic solution for definitive differentiation of true and false threatened preterm labour cases

INNITIUS aims to optimize TPTL diagnosis with Fine Birth, a non-invasive AI-driven device that assesses cervical tissue consistency, seeking €2.5M for further development and regulatory approval.

Subsidie
€ 2.342.835
2023

Projectdetails

Introduction

Threatened Preterm Labour (TPTL) is the leading cause of preterm births and hospitalization during pregnancy. With 45 million cases annually, treatments and resources are not being properly allocated towards the patients who need them.

Importance of Efficient Diagnosis

Efficient diagnosis of TPTL is the key to optimizing treatments; however, current methods are ineffective at detecting true events.

Innovation by INNITIUS

INNITIUS has developed Fine Birth, the first non-invasive PoC diagnostic device that uses torsional waves and AI to directly measure a patient’s cervical tissue consistency to identify the risk of TPTL in real-time.

Features of Fine Birth

  • Objective
  • Accurate
  • Fast
  • Can be operated by staff with minimal training

Development Status

We have reached TRL6, testing the prototype in a multicentre clinical study with over 300 patients in 7 sites.

Funding Requirements

We need €2.5 million to fully develop and validate our AI software, conduct a multicentre pivotal clinical trial, and obtain regulatory approval, which we will be able to finalize with the support of the EIC.

Financiële details & Tijdlijn

Financiële details

Subsidiebedrag€ 2.342.835
Totale projectbegroting€ 3.346.908

Tijdlijn

Startdatum1-4-2023
Einddatum31-3-2026
Subsidiejaar2023

Partners & Locaties

Projectpartners

  • ULTRASOUND-INNOVATION MEDTECH SOCIEDAD LIMITADApenvoerder

Land(en)

Spain

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