Periodic Reporting for period 3 - FETAL MONITORING (Safe and accurate fetal monitoring)
Reporting period: 2017-12-01 to 2018-10-31
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 has responded to this market need and successfully managed to demonstrate commercial readiness with its first Nemo Fetal Monitoring System (NFMS) allowing for the simultaneous recording of maternal heart rate (MHR), fetal heart rate (FHR) and uterine activity (UA). The NFMS 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 NFMS is able to transfer the recorded data wirelessly.
The NFMS is expected to 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 deviation treatment and avoidance of unnecessary surgery).
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 has responded to this market need and successfully managed to demonstrate commercial readiness with its first Nemo Fetal Monitoring System (NFMS) allowing for the simultaneous recording of maternal heart rate (MHR), fetal heart rate (FHR) and uterine activity (UA). The NFMS 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 NFMS is able to transfer the recorded data wirelessly.
The NFMS is expected to 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 deviation treatment and avoidance of unnecessary surgery).
During the lifespan of the project (July 2016 - October 2018) in total 16 Deliverables have been delivered within budget and specifications, 8 Milestones have been reached successfully. Two of the key milestones were the CE Marking for the NFMS obtained on 9 and 31 October 2018 (Annex III and IV of the Medical Device Directive 93/42/EEC) and the preparation for the FDA Premarket Notification (510 k) completed with submission of the technical file on 22 October 2018 and acknowledgement of completeness by FDA on 31 October 2018.
Achievements on Technical Validation
The main objective for the Technical Validation phase was to further develop Nemo’s proof-of-concept technology into a patient monitoring system for safe and accurate fetal monitoring for commercial release (TRL9). To achieve this goal, the technology has not only been further improved but also miniaturized. The technology improvement includes improvement of the data acquisition hardware and improvement and embedding of the signal processing algorithms that are aimed at providing maternal heart rate, fetal heart rate, and uterine activity.
Achievements on Clinical Validation
The main objective of the clinical validation was to validate the NFMS in a multicentre clinical study performed by key opinion leaders within the European Association of Obstetrics and Gynaecology. Overall performance of the NFMS device is good. NFMS has a very high reliability for MHR and a high reliability for FHR (superior to conventional techniques), even in obesity. Uterine activity measurements could not be evaluated for clinical reasons, but bench-tests to a CE- and FDA-approved competitor (PUREtrace) shows an improved output of uterine activity.
Achievements on Dissemination and Exploitation
The dissemination and exploitation activities have been reported regularly as part of the periodic reports, the dissemination activities have been shared publicly via our project website www.nemohealthcare.com which has been updated regularly. During the last project period, efforts have been put on the exploitation of the results, anticipating and following the official market launch of the NFMS on 20 November 2018.
Throughout the Horizon 2020 project there was much enthusiasm among national and international gynaecologists to participate in our projects. Our sales funnel is developing well and first NFMS customer orders are expected soonest.
Before the official product launch (20 November 2018), Nemo has already visited over 50 customers in target markets, introducing Nemo and showing the product. There has not been a single customer yet that has not shown interest in the product or technology. The added value is clearly recognized. Approximately 20% of the visited customers has already asked and received a quotation and the amount of quotation requests is building up.
Achievements on Technical Validation
The main objective for the Technical Validation phase was to further develop Nemo’s proof-of-concept technology into a patient monitoring system for safe and accurate fetal monitoring for commercial release (TRL9). To achieve this goal, the technology has not only been further improved but also miniaturized. The technology improvement includes improvement of the data acquisition hardware and improvement and embedding of the signal processing algorithms that are aimed at providing maternal heart rate, fetal heart rate, and uterine activity.
Achievements on Clinical Validation
The main objective of the clinical validation was to validate the NFMS in a multicentre clinical study performed by key opinion leaders within the European Association of Obstetrics and Gynaecology. Overall performance of the NFMS device is good. NFMS has a very high reliability for MHR and a high reliability for FHR (superior to conventional techniques), even in obesity. Uterine activity measurements could not be evaluated for clinical reasons, but bench-tests to a CE- and FDA-approved competitor (PUREtrace) shows an improved output of uterine activity.
Achievements on Dissemination and Exploitation
The dissemination and exploitation activities have been reported regularly as part of the periodic reports, the dissemination activities have been shared publicly via our project website www.nemohealthcare.com which has been updated regularly. During the last project period, efforts have been put on the exploitation of the results, anticipating and following the official market launch of the NFMS on 20 November 2018.
Throughout the Horizon 2020 project there was much enthusiasm among national and international gynaecologists to participate in our projects. Our sales funnel is developing well and first NFMS customer orders are expected soonest.
Before the official product launch (20 November 2018), Nemo has already visited over 50 customers in target markets, introducing Nemo and showing the product. There has not been a single customer yet that has not shown interest in the product or technology. The added value is clearly recognized. Approximately 20% of the visited customers has already asked and received a quotation and the amount of quotation requests is building up.
Being at the end of the project, Nemo has no reason to question the anticipated societal and economic impacts as described in Part B of the Grant Agreement.
The results of this Fetal Monitoring project directly relate to the challenges of the work program PHC12-2014-1 ‘clinical research for the validation of biomarkers and/or diagnostic medical devices’.
The NFMS offered by Nemo will allow for a comfortable and safe monitoring, while providing highly accurate data needed in order to improve perinatal diagnostics and thus reduce the risk of complications during pregnancy and birth. This will significantly reduce costs of healthcare, thus stimulating both the target groups and insurance companies to invest in the technology.
As a consequence the NFMS will directly contribute to increasing sales of Nemo and will enable the company to grow.
To execute the project and to prepare for the expected growth in the coming years Nemo has hired 8 new staff members since the start of the project. Further growth in staffing is expected in due course.
The results of this Fetal Monitoring project directly relate to the challenges of the work program PHC12-2014-1 ‘clinical research for the validation of biomarkers and/or diagnostic medical devices’.
The NFMS offered by Nemo will allow for a comfortable and safe monitoring, while providing highly accurate data needed in order to improve perinatal diagnostics and thus reduce the risk of complications during pregnancy and birth. This will significantly reduce costs of healthcare, thus stimulating both the target groups and insurance companies to invest in the technology.
As a consequence the NFMS will directly contribute to increasing sales of Nemo and will enable the company to grow.
To execute the project and to prepare for the expected growth in the coming years Nemo has hired 8 new staff members since the start of the project. Further growth in staffing is expected in due course.