Periodic Reporting for period 1 - ARFM (Automated Remote Foetal Monitoring) Periodo di rendicontazione: 2019-02-01 al 2019-07-31 Sintesi del contesto e degli obiettivi generali del progetto There is an urgent medical need to improve foetal monitoring while addressing healthcare cost issue, but cardiotocographs have shown no major innovation since its creation. Cardiotocographs (CTGs) are still difficult to place for some patients, not always reliable (especially in case of foetal movement) and require medical staff nearby for data acquisition. To answer this unsatisfactory observation, the ARFM project Phase 1 aimed at developing the first CTG allowing patient self-monitoring at home with a high standard of care, thanks to an automated detection of foetal heart rate (FHR), a discrimination of FHR from maternal environment, a mobile and connected device, associated to a telemedicine platform. SME Instrument Phase I objectives were to conduct studies to refine regulatory, clinical, and market access strategy for Nateo Healthcare’s CTG. Lavoro eseguito dall’inizio del progetto fino alla fine del periodo coperto dalla relazione e principali risultati finora ottenuti During ARFM project, Nateohealthcare conducted the following activities:- 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. Progressi oltre lo stato dell’arte e potenziale impatto previsto (incluso l’impatto socioeconomico e le implicazioni sociali più ampie del progetto fino ad ora) Results are described in the previous section. 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. Company logo
