Periodic Reporting for period 1 - ARFM (Automated Remote Foetal Monitoring)
Berichtszeitraum: 2019-02-01 bis 2019-07-31
- To prepare clinical trials, a regulatory study was carried out for Nateohealthcare’s CTG. For Europe, further assessment of the new EMA regulations for medical devices validated the medical device classification of Nateohealthcare’s CTG. Furthermore, design of the clinical trial protocol to obtain CE marking of maternity CTG has been initiated with Nateohealthcare’s subcontractors: patient number, clinical trial design… This work led Nateohealthcare to modify the clinical trial design to adapt the study to the targeted indications for Nateohealthcare’s CTG (study population, intended use evaluated: intrapartum or prepartum use…).
- For market access strategy, a market study on wireless foetal monitoring systems allowed Nateohealthcare to identify the first European markets targeted for Nateohealthcare’s deployment, according to CTG market but also to the use of digital technology in healthcare pathway. A discrepancy between European countries in the integration of digital technology in healthcare pathway has been shown. Nateohealthcare will hence first target countries which already have implemented telemedicine.
- Refining Business Plan: In a first approach, Nateohealthcare performed a preliminary market analysis and built up a simplified business plan regarding the ARFM project. These studies showed a favourable market context. During the SME Instrument Phase 1 feasibility study, Nateohealthcare consolidated a detailed business plan related to the commercialisation of its products, including further analysis of barriers to entries and market opportunities.
As regards socio-economic impacts the ARFM project aims at developing a disruptive CTG to improve foetal well-being monitoring, enhance neonatal outcomes (deaths, sequelae), and generate a 50% decrease of healthcare cost related to at-risk pregnancies with at-home monitoring.
With 2.7 million new-born babies and 0.3 million pregnant women who died in 2015, making pregnancy safer is a public health priority worldwide. It is estimated that 70% of neonatal deaths could be avoided. Even though foetal monitoring with cardiotocographs (CTG) is the medical reference since 1968, it remains unsatisfactory with problems related to CTGs observed in 25% of foetal deaths. Moreover, antenatal hospitalisation for at-risk pregnancies is costly, and will grow in the future. With the SME Instrument Phase 1, Nateoheathcare now stands on firm ground to bring in the next coming years a disruptive CTG to European patients.