A medical device determining the daily amount of breast milk to improve neonatal nutrition andmothers’ psychophysics well-being.

Project Information

Galastick

Grant agreement ID: 728382

DOI

10.3030/728382

Project closed

EC signature date 10 May 2016

Start date 1 June 2016

End date 30 September 2016

Funded under

• SOCIETAL CHALLENGES - Europe In A Changing World - Inclusive, Innovative And Reflective Societies

Total cost

€ 71 429,00

EU contribution

€ 50 000,00

Coordinated by

GALASCREEN SRLS
Italy

Periodic Reporting for period 1 - Galastick (A medical device determining the daily amount of breast milk to improve neonatal nutritionandmothers’ psychophysics well-being.)

Reporting period: 2016-06-01 to 2016-09-30

Summary of the context and overall objectives of the project

"Less than 40% of infants are exclusively breastfed globally and the goal for WHO by 2025 is it to increase until 50%. If every child were breastfed within an hour of birth, and then continually breastfed until 2 years, about 800,000 child lives would be saved every year. The questions are: Do I have enough milk? Is my milk effective to defend my baby from illnesses?
GalaStick is a disposable medical device able to determining the lactation onset and the progressively increasing daily amount of breastmilk. The stick uses a lateral flow immunochromatographic assay that works simply detecting the presence (or absence) of a target analyte in the human milk sample. ""Biological diversity among people, reveals that not all mothers are the same. For some of them (not a few) it occurs that they are not able to successfully breastfeed their babies. Breastfeeding without ""feeding"" can cause frequent crying and colic in the newborn and nervousness in mothers, lack of confidence in their abilities and depression. A mother starts to feel inadequate, undermining her psychological wellness. On the other hand, several mothers have breastmilk in excess and could donate it to preterm infants in midwiferies, thus promoting the babies' health and reduce hospitals' costs.
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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 main objective of the Phase 1 project was to elaboration of a comprehensive and soundness business plan and deepen the study on the requirements and standards for medical devices and define a minimum viable product for the GalaStick. Market survey was show several potential competitor and competitive solution. The pricing for each segment and commercialization strategy was defined.

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)

GalaStick offers this unique value to measure milk amount and milk immune profile identify a key element (the p-LAP) and its supports all mums in several lactation phases: from beginning of the breastmilk to weaning by reaching the condition of long breastfeed. The market analysis of this feasibility study highlighted that breastfeeding supplies in Europe is forecast to grow at a Compounded Average Growth Rate (CAGR) of 4.44% during the next 4 years (2016-2020). Our analysis shows that no similar medical devices are on the market by according to its scientific basis, technical functions, usability and accuracy, which represent key properties for lactating mothers. Since the biomarker discovery made by GalaScreen represents the first time that this biomarker has been isolated so it has never been reported anywhere, neither in the scientific literature nor in the patent literature. Galastick verifies in real time milk properties for a long and conscious babies nutrition.

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