BILISTICK: A low cost point-of-care for early diagnosis of hyperbilirubinemia in newborns

Informations projet

BILISTICK

N° de convention de subvention: 710971

DOI

10.3030/710971

Projet clôturé

Date de signature de la CE 17 Decembre 2015

Date de début 1 Février 2016

Date de fin 31 Juillet 2016

Financé au titre de

• SOCIETAL CHALLENGES - Health, demographic change and well-being

Coût total

€ 71 429,00

Contribution de l’UE

€ 50 000,00

Coordonné par

BILIMETRIX SRL
Italy

Periodic Reporting for period 1 - BILISTICK (BILISTICK: A low cost point-of-care for early diagnosis of hyperbilirubinemia in newborns)

Période du rapport: 2016-02-01 au 2016-07-31

Résumé du contexte et des objectifs généraux du projet

Severe neonatal jaundice affects at least 481.000 newborns annually, from which 114.000 die and more than 63.000 survive with neurological sequelae caused by kernicterus/Chronic Bilirubin Encephalopathy (CBE). CBE is largely preventable if severe hyperbilirubinemia is early identified and treated. Indeed, AAP Guidelines (adopted by EU) recommend bilirubin screening during the first two week of life. However, existing solutions for bilirubin determination are inaccessible for many medical settings, especially in Low and Middle Income Countries (LMICs), been them expensive or not enough accurate. The aim of the project is to perform a feasibility study to evaluate the success of the business to lead to the international market Bilistick® System, a low-cost Point-of-Care for early diagnosis of hyperbilirubinemia. Bilistick® is the only low cost, minimally invasive, portable in vitro rapid POC diagnostic device for bilirubin assay.

Travail effectué depuis le début du projet jusqu’à la fin de la période considérée dans le rapport et principaux résultats atteints jusqu’à présent

During the development of the project, Bilimetrix analysed the main aspects for feasibility study, such as: market potential; analysis of competitors; possible pricing systems and methods of distribution; description of products and production process; individuation of partners (manufacturers, suppliers, distributors); market access and sales projection. Furthermore, it has developed an IPR protection strategy for the system and the trademark “Bilistick®” was registered. A special focus was done on regulatory requirements needed: Bilimetrix obtained the CE mark for the Bilistick® products and company certification ISO 13485:2012. Based on outcomes of the analysis, a financial analysis evaluation was done (5-year planning horizon). From a financial point of view, the project presents promising projections and sustainability. The main indicators for financial sustainability such as net income statement, cash flow and other estimated financial/economic reports resulted positive, supporting the feasibility of the project. As part of marketing costs considered, it was considered the possibility to sell an average of 10 devices per year at the production cost to selected institutions, and to grant to hospitals and organizations in selected LMICs some devices.

Progrès au-delà de l’état des connaissances et impact potentiel prévu (y compris l’impact socio-économique et les conséquences sociétales plus larges du projet jusqu’à présent)

Based on the outcomes obtained from the feasibility study, it was demonstrated the validity of the project from a market, production and financial point of view. Bilimetrix plans to continue the development of the project until the insertion of the Bilistick® products in the market.

Bilistick® System, usefull where is needed

Bilistick® System, in vitro rapid POC Bilirubin assay

Bilistick® System