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Report

Teaser, summary, work performed and final results

Periodic Reporting for period 2 - FETAL MONITORING (Safe and accurate fetal monitoring)

Teaser

Summary

The problem and the importance for society:
During gestation and birth, problems are encountered in up to 15% of all births. Most problems are related to fetal
hypoxia and preterm birth. It is estimated that every year over 30.000 babies in Europe suffer from birth asphyxia,
despite the common use of monitoring. Recent Norwegian research (2013) revealed inadequate fetal monitoring is
responsible for 50% of the cases where human error caused birth asphyxia (oxygen deficiency). It can be concluded
that current monitoring technology does not detect vital information on fetal wellbeing, causing unnecessary risks
which can eventually lead to fetal mortality. There is thus a clear market need for fetal monitoring technology that
is accurate, safe (non-invasive) and easy to use.

The overall objectives:
Nemo Healthcare is responding to this market need through the development of an innovative electrode patch and hardware/software module that can
simultaneously record uterine activity and fetal heart rate. The solution of Nemo is characterized by unique and smart
algorithms that can accurately and real-time filter contractions and the fetal heart rate from unprocessed abdominal
electrophysiological signals, successfully eliminating noise or interference. The solution will be able to transfer the
recorded data wirelessly. The solution will create a breakthrough in the field of fetal monitoring: it will result in better
diagnoses, improved quality of care, a reduced number of birth-related problems, increased user friendliness (for
medical staff as well as the patient) and lower healthcare cost (through remote monitoring, reduced treatment and
avoidance of unnecessary surgery).

Work performed

The main focus and achievements during the first reporting period (M1-11) are summarized here below:

â€¢ WP1 Project Management:
The main focus in WP1 during the first reporting period has been on establishing an adequate project structure and organization. Accordingly, each WP is properly staffed and led by a senior project leader. A Kick off meeting (MS1) was held and since project progress review meetings are held on a weekly basis.
The EC honoured the request for shortening the first reporting period from 12 to 11 months and to implement an intermediate periodic reporting period (M12-17).

â€¢ WP2 Technical Validation:
The main focus in WP2 during the first reporting period has been on realizing the technical specification freeze for the PUREtrace NextGen system, hereafter â€œAtlantisâ€ system. In order to be able to freeze said specification, several feasibility studies and proof of concept tests were carried out to select the appropriate topologies, power management solution and wireless communication solution.
Furthermore, a benchmark study of alternative sensor electrode materials was conducted, leading to valuable insights to be applied in the improved design of the Parides electrode patch.
In addition we achieved substantial improvements in the software for abdominal ECG data registration. Last, but not least, preparation work was conducted for CE filing and FDA clearance with most notably a regulatory pathway review for the anticipated Atlantis system by Nemoâ€™s designated notified body.

â€¢ WP3 Clinical Validation:
The main focus in WP3 during the first reporting period has been on developing and implementing a data management plan and the setup and start of the first phase of the study for clinical validation. The protocol for the validation study was approved by the Medical Ethical Committee of Maxima Medical Center in Veldhoven (The Netherlands) on December 1, 2016. The resulting data is used to improve the final configuration of the Atlantis system and electrode patch, which will be used for the final clinical validation.
Furthermore, focus was on approaching other national and foreign clinical centres for participation in the final clinical validation study.

â€¢ WP4 Dissemination and Exploitation:
The main focus in WP4 during the first reporting period has been on market preparation and sales enabling activities. A detailed planning for identifying timings and potential challenges for various marketing tools and materials was established. A project website is implemented and a Sales & Marketing plan realized. A Health Technology Assessment was executed and important marketing instruments such as an on-line e-learning tool and a distributor survey are being developed and implemented.
Next to visiting several valuable conferences and tradeshows, Nemo organized successfully its first symposium for obstetricians/gynaecologists and midwives, with over 100 attendees.

The main focus and achievements during the second reporting period (M11-17) are summarized here below:

â€¢ WP1 Project Management
The main focus in WP1 during the second reporting period has been on managing the project through the crucial Design phase and preparing for the Verification phase, notably the final validation study (F2). The Design phase is successfully completed with the delivery of the final commercial prototype fetal monitoring system on December 1. Also, approval from the Medical Ethical Committee of MMC Veldhoven was obtained for the validation study on December 22, allowing for start of the F2 validation study in January 2018.
Project progress review meetings continued to be held on a weekly basis.

â€¢ WP2 Technical Validation
- Final prototypes for the Atlantis base-station and headbox have been delivered on December 1
- The Design phase has been concluded by an official internal review meeting on December 13 and December 19

â€¢ WP3 Clinical Validation
- Primary endpoints for final validation study have been de

Final results

At this point in the project, Nemo has no reason to question the societal and economic impacts of said project as per the described expected impacts in section 2.1 of the Fetal Monitoring project plan.
Since the start of the project and until PR2, Nemo has hired 8 new staff members and has hired an additional 2 FTE that have started in January 2018.