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SensUS: A non-invasive and quantitative ultrasound (QUS) device for an objective monitoring of the childbirth labour process.

Periodic Reporting for period 1 - SensUS (SensUS: A non-invasive and quantitative ultrasound (QUS) device for an objective monitoring of the childbirth labour process.)

Période du rapport: 2018-01-01 au 2018-04-30

Five million children are born annually in Europe. Of them, 1.5 million of all births occur by C-Sections. Caesarean births cost 1.5 times more than a natural birth and expose the mother and foetus to a mortality risk four times bigger.
Current labour monitoring methods depend on doctor’s skills, with invasive and even painful manual examinations. The few medical devices available for intrapartum examinations are complex to use.
Amolab has developed SensUS, a quantitative ultrasound device that monitors the advancement of the foetus along the birth canal.SensUS provides an objective and accurate evaluation, supporting the decision-making and contributing to reducing unnecessary C-Sections.
Our SME Instrument Phase 1 had the objective of validating the technical, commercial and financial feasibility.
During the Phase 1, we defined the plan for technical development, including optimisation of hardware and software. After analysing our production capacity and ways to reduce production cost, we decided to incorporate a partner specialist in the development of echographic software. Amolab developed the clinical protocol for a multicentre clinical trial, and found three hospitals that will join as subcontractors for the Phase 2.
Once our workplan was defined, we established the budget and did a risk analysis, including mitigation strategy. For the commercialization, we have been looking for potential distributors through our partner. Amolab also reviewed our IP strategy, confirming our Freedom To Operate. Finally, we created a more detailed financial model to assess the profitability of our business in the next five years.
The WHO recommends the rate of CS to be not higher than 15% of the childbirth deliveries. However, the rates of CS in the world exceed this recommendation. For instance, in Europe the CS rate is close to 29% of all childbirth deliveries.
C-Sections have severe medical risks for mother and child, but also have a big economic impact for healthcare systems.
The average excess cost of a CS is €1,000 compared to vaginal delivery. Considering 1.5 million children born by CS per year in Europe and that 50% of them are unnecessary CS, the extra costs generated in the obstetrics sector is € 750 million. The current practices (manual examinations) and ultrasound labor-monitoring devices are not enough to fight the trend of increasing C-Sections. With SensUS, we are going will introduce a fast, easy-to-use and affordable device that will massively reduce unnecessary medical care costs and negligence demands.
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