Smartphone-based monitoring of jaundice in newborns

Project Information

Picterus

Grant agreement ID: 946013

DOI

10.3030/946013

Project closed

EC signature date 3 April 2020

Start date 1 March 2020

End date 31 August 2022

Funded under

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Total cost

€ 2 382 005,00

EU contribution

€ 1 663 903,50

Coordinated by

PICTERUS AS
Norway

Periodic Reporting for period 2 - Picterus (Smartphone-based monitoring of jaundice in newborns)

Reporting period: 2021-01-01 to 2022-08-31

Summary of the context and overall objectives of the project

Worldwide, 114,000 newborns die each year due to neonatal jaundice, a common condition caused by high levels of bilirubin. Approximately the same number of children grow up with permanent disabilities associated with brain damage when jaundice is not diagnosed early and treated. Current solutions for jaundice diagnosis require hospital laboratory facilities for blood testing and newborn monitoring by professional healthcare workers. Estimations indicate that jaundice management increases healthcare costs by €1684 million every year.

To address this, Picterus have developed innovative technology based on biomedical optics and photonics complemented with machine learning algorithms that facilitate accurate remote diagnosis of jaundice by taking a simple picture with a smartphone. Unlike the current solutions used for jaundice diagnosis, Picterus enables health personnel and parents to screen newborns for jaundice with a tool that is reliable and comes at a low cost, regardless of the geographical location.

By using Picterus, midwives or nurses doing early home-visits can safely assess the degree of jaundice in the newborn and save time that can be allocated to other needs that the newborn or family might have. It reduces the need for hospital visits, and further, it reduces stress on the midwives and parents. The reduction in healthcare costs, due to remote and low-cost diagnosis of neonatal jaundice, will allow better allocation of resources in other important medical areas, but our contribution to solving the problems associated with jaundice in low- and middle-income countries (where current tools are often too expensive for a routine use) will produce a more significant impact. Picterus has the capacity to reduce outpatient visits for jaundice by 50%, with potential savings of €306 million. Through commercialisation of this innovation, we have projected that our global turnover will reach €25 million and create a total of 14 direct jobs by the 4th year of introduction.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

The project has made good progress in the scientific and technical areas during the last 20 project months, although the COVID-19 pandemic has delayed the achievements selected milestones and deliverables. In addition, Picterus AS has obtained the CE-certification, with the application to extend to a wider group of users under review. In order to maintain our certification and ensure compliance with ethical and data management regulations in the EU and in our medical studies’ sites, the data management and quality management systems developed during the first reporting period are regularly updated. The use of resources is aligned with the planned budget.

Picterus implemented a number of dissemination activities, including publications in technology and finance magazines, pitches and presentations at international conferences, support and supervision of student projects and associated dissemination, and academic posters.

We concluded medical studies in Sweden and Uganda and further studies in the Netherlands and Norway are on-going. Additionally, Picterus AS co-supervised student research projects using our technology in Norway, the Philippines, Nigeria and Mexico. Several medical trials and co-supervised student projects are under preparation in Europe, South-east Asia, Africa and the Americas. All studies have a dedicated purpose; either for the evaluation of user experiences, generating data for the technical development of the project, or verify the product for market-, certification-oriented or post-marketing surveillance activities. Internal procedures have been set up to ensure that ethical requirements for the notification, review and authorization of each study are followed.
The CE-certification was obtained in October 2021 and approval for extending the use of the technology to lay users is pending. We signed a contract with a notified body in Germany (DQS Medizinprodukte GmbH). The Quality Management System (QMS) was established and re-certificated in Dec 2020 by BSI Netherlands (ISO 13485). Additionally, an application to the FDA for commercialization in the US has been submitted in July 2022 and is currently under review.

Picterus has experienced big development in particular with the exploitation activities. The company is expanding, and 3 new employees have been recruited and 3 new recruitments are under way in the project period.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

Picterus’ technical advantages vs state of art solutions:
Picterus offers an affordable and accurate method to diagnose jaundice, faster and less invasively than available methods. Picterus has better precision than clinical testing and the ingram icterometer. Picterus will not require a lab or high competence to use it, but still offers accuracy comparable to blood tests. It will be cheaper and more available than existing products on the market since the application can be downloaded from anywhere with an internet connection and the calibration card is a one-time investment.

Picterus has the following unique features over the state of the art:
● User friendly and easy access tool from any smartphone or tablet.
● High accuracy as the result of our exclusive biomedical optics technology, eliminating the need to visit hospitals.
● Immediate results and easy interpretation (no need of professional training).
● Offline tool for easy access everywhere even in low-income countries.
● Remote monitoring of the patient from any hospital or healthcare centre.
● Two versions, with different functionalities, available for both professionals and parents.
● Low-cost solution in comparison with other diagnostic solutions.

Picterus will provide paediatricians, midwives, and parents with an innovative screening tool for remote monitoring of neonatal jaundice in an easy, accessible, reliable, and cost-effective manner.

Benefits for society:
The reduction in healthcare costs, due to remote and low-cost screening of neonatal jaundice, will allow better allocation of resources in other important medical areas in high- and middle-income countries alike. Our contribution to solving the problems associated with jaundice in low- and middle-income countries will produce a significant impact. In low-income countries, jaundice is among the most common conditions causing kernicterus; the incidence of fatalities is much higher than in western countries. Our powerful offline version will be very useful in these countries where internet access can be limited. Worldwide, there are 114,000 child deaths per year and 63,000 children who survive with kernicterus (severe brain damage), reducing that number will be enormously valuable for society. Our tool could further serve as a method for collecting data on newborn health status in a region. This could be of important value for health governments or organisations working in underserved areas where such statistics are difficult to gather.

Picterus Clincal Trial

Picterus Clinical App

Testing of Picterus device on a newborn baby

Presentation of the Picterus App at FIME