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Report

Teaser, summary, work performed and final results

Periodic Reporting for period 1 - Fine Birth (Diagnosis of preterm birth risk and success of induced labour)

Teaser

Summary

Preterm Labor: a huge impact in our society
In recent years, the European Union\'s political institutions have recognised the importance of addressing the health well-being of targeted population groups; aging, youth and special health care needs. However, we have ignored one of the most important vulnerable groups of all- our new-born children.
Approximately 500,000 preterm births occur in the EU every year and 15.000.000 worldwide, creating a significant burden on the affected children, family, insurers, employers and health services.
Preterm births are classified into two categories:
(1) Indicated: those deliveries initiated by the clinician and (2) Spontaneous preterm birth: those that follow either threatened preterm labour (TPL) (50%), infections (30%) or spontaneous rupture of the membranes (PPROM) (20%). There is no test that can accurately predict who might have a preterm birth.
Going deep into the sources data, TPL represents one of the main causes of hospitalization during pregnancy, and only in the US it generates an economic burden of $820M. This number is not only due to the threats that lead to spontaneous PB, but much of that cost is due to the hospitalization of false threats: only 15% of the TPL leads to a spontaneous delivery in the following 7 days.
Cervicometry test is not reliable enough and existing in-vitro tests are too expensive to be applied at every TPL and their use is not extended, and obstetricians need an accessible tool that could be applied as a regular tool at every patient with labor dynamic symptoms.

Fine Birth: Diagnostic of false threatened preterm labor cases on-site

Innitius proposes the Fine Birth, a non-invasive device that by the use of torsional waves (own patented technology), analyzes the consistency of the cervical tissue and is able of emitting in real time a diagnosis about whether the patient is in labor or it is a false threat.

The Fine Birth technology aims to be integrated into current & new ultrasound systems -available in all gynecology offices-to maximize entry into healthcare systems.

Our main competitive advantages over alternative tests (FFN / PAMG-1 Tests) are: (1) low cost per test, (2) the possibility of performing the cervicometry test before our test and (3) overcome the false positive diagnostic cases due to sperm or lubricant presence.
At the beginning of the Project, Fine Birth was technology already validated for the measuring of cervix consistency mechanical properties. Initially, three main used were identified: prognosis of preterm delivery risk at week 20 of pregnancy -prevention-, assessment of induction labor success probabilities -induction- and diagnosis of imminent labor -intervention-.
Objectives of the feasibility study
The overall objective of the feasibility study was to detail the route to market for Fine Birth.
Question to be answered Outcome
Are potential customers interested enough in the features of our value proposition to pay for it?
Interest and relevance tested
Willingness and ability to pay tested
Which features of our value proposition do potential customers prefer? What are missing?
What do they really value? What do they prioritize? List of improvements to be implemented
What is the clinical care decision making process, who are the key stakeholders and key dissemination targets in European markets?
Stakeholders mapped
Key decision makers identified
Beachhead markets selected
What is the total size of the market, based on the identified users?
TAM, SOM, SAM quantified
What regulatory steps must be completed to bring Fine Birth to market?
Regulatory analysis with the roadmap and costs associated to the regulatory aspects in EU and USA.
How will this understanding of the users, the market and our product change the business plan?
Business plan updated

Work performed

During the project we have undertaken a quantitative survey of 100 Gynecologists and obstetricians and a qualitative Face-to-face, skype and phone interviews with the different stake holders.
Based on the results from this feedback, we undertook desk based research to analyse the results in terms of:
- Understand the product specification the market wants and willingness to pay for this product
- Understand who the key users are, the payers, and identify the beachhead markets
- Quantify the market
- Understand whether it is technically possible to deliver the product the market demands
From this we were able to:
- Detail the product development roadmap, including regulatory steps necessary to bring Fine Birth to market.
- Adapt the business plan to this new vision of the company and detail the financial projections after the phase 2 project.

Final results

Our technology deals with PreTerm Births. Approximately 500,000 preterm births occur in the EU every year and 15.000.000 worldwide, creating a significant burden on the affected children, family, insurers, employers and health services. The total cost of PTB in the US was estimated at $26 billion.
Although spontaneous PTB is a heterogeneous phenotype, cervical softening, shortening and dilatation is a recurring feature. In many patients, cervical changes appear to be caused by a reduction in the shear mechanical properties of the cervical tissue. It has been recognised that accurately measuring the shear mechanical properties of the cervix would make it possible to diagnose the risk of PTB.

Fine Birth is a non-invasive, in-vivo diagnostic device that uses torsional ultrasound waves to measure the shear mechanical properties of the patientâ€™s cervix tissue, diagnosing the risk of delivery events in real time.
The first application of the technology will be to identify when a threatened preterm labour will result in a spontaneous preterm birth.
TPL represents one of the main causes of hospitalization during pregnancy, generating an economic burden of $820M only in the US. Over half of this cost is due to the hospitalization of false threats. In fact, only 15% of the TPL leads to a spontaneous delivery in the following 7 days after the event and 40% of total threats will end in a birth on the date of natural birth.
A single unnecessary admission of a patient suspected of having preterm labor (PTL) but who does not actually have the condition costs $20,300 on average. On the other hand, between 33% and 42% of patients who have an initial TPL, return to the emergency room during the same pregnancy with a new threat, which means an increase in the cost associated with the problem.
Our low cost, accurate and fast test allows clinicians to easily identify false Threatened Preterm labor. This will:
- Reduce the number of unnecessary hospitalizations by half
- Allow clinicians to focus their resources on interventions that can improve neonatal outcomes
- Reduce doctorâ€™s responsibility

These impacts will occur once we have completed the clinical trials and brought Fine Birth to market, which will be the objective of a future SME instrument phase 2 project.