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
