Periodic Reporting for period 3 - TheCoroRevolution (The Coro: a revolutionary product to bring breastfeeding into the 21st century)
Reporting period: 2022-03-01 to 2023-08-31
Breastfeeding is one of the most effective ways of ensuring child survival and future health, says the WHO, also recommending exclusive breastfeeding to 6 months. Despite the inarguable and profound benefits to baby, mother and society, globally only 36% of infants are exclusively breastfed. Alarmingly for Europe, recent data shows that our continent has the lowest breastfeeding rates with only 13% of infants being exclusively breastfed.
For the child, breastfeeding reduces the risk of infection: the risk of death due to infection of non-breastfed babies is double that of breastfed infants. It protects against ear, throat, and sinus infections well beyond infancy. For the mother, breastfeeding for more than 12 months reduces risk of breast and ovarian cancer by 26% and 37%, respectively, and it is associated with up to 32% lower risk of type 2 diabetes.
There must be considerable barriers to breastfeeding, with up to 60% of women dissatisfied with how long they breastfed. Individual barriers to exclusive breastfeeding have been explored extensively, and based on a large body of academic literature “concern regarding milk supply” is identified globally as a primary factor in breastfeeding cessation and in introduction of formula, this being true for 95% of breastfeeding women in Germany, 64% in Italy, 56-60% in Sweden and 40% in Norway.
Coroflo wants to tackle this main obstacle to drastically increasing breastfeeding rates and adherence to the WHO recommendation of 6-month exclusive breastfeeding. Coroflo wants to provide a reliable, inexpensive and non-invasive alternative to the existing standards of test weighing, currently the established clinical method to assess weight gain in breastfeeding infants. In a world where e-health is exploding and our every heartbeat, step and calorie burned is being tracked, we want to immediately and accurately let a mother know if her baby is getting enough milk, a top-level concern of any parent.
Coroflo’s objective was to develop Coro, the first accurate breastfeeding monitor: a nipple shield with an integrated micro-flow sensor measuring real-time the amount of breastmilk a baby is getting, ending the data to the mother's smartphone. By the end of the project, Coroflo had brought Coro to a state of completion, ready to be manufactured and made available to mothers. Additionally, Coro was tested against the existing standard of test weighing in clinical trials, and results were collated with both achieved and imminent publications of the peer reviewed studies to endorse both the accuracy of the device, and the value of the measurements obtained in clinical and research settings.
For the child, breastfeeding reduces the risk of infection: the risk of death due to infection of non-breastfed babies is double that of breastfed infants. It protects against ear, throat, and sinus infections well beyond infancy. For the mother, breastfeeding for more than 12 months reduces risk of breast and ovarian cancer by 26% and 37%, respectively, and it is associated with up to 32% lower risk of type 2 diabetes.
There must be considerable barriers to breastfeeding, with up to 60% of women dissatisfied with how long they breastfed. Individual barriers to exclusive breastfeeding have been explored extensively, and based on a large body of academic literature “concern regarding milk supply” is identified globally as a primary factor in breastfeeding cessation and in introduction of formula, this being true for 95% of breastfeeding women in Germany, 64% in Italy, 56-60% in Sweden and 40% in Norway.
Coroflo wants to tackle this main obstacle to drastically increasing breastfeeding rates and adherence to the WHO recommendation of 6-month exclusive breastfeeding. Coroflo wants to provide a reliable, inexpensive and non-invasive alternative to the existing standards of test weighing, currently the established clinical method to assess weight gain in breastfeeding infants. In a world where e-health is exploding and our every heartbeat, step and calorie burned is being tracked, we want to immediately and accurately let a mother know if her baby is getting enough milk, a top-level concern of any parent.
Coroflo’s objective was to develop Coro, the first accurate breastfeeding monitor: a nipple shield with an integrated micro-flow sensor measuring real-time the amount of breastmilk a baby is getting, ending the data to the mother's smartphone. By the end of the project, Coroflo had brought Coro to a state of completion, ready to be manufactured and made available to mothers. Additionally, Coro was tested against the existing standard of test weighing in clinical trials, and results were collated with both achieved and imminent publications of the peer reviewed studies to endorse both the accuracy of the device, and the value of the measurements obtained in clinical and research settings.
Within the duration of the project Coroflo was able to bring the Coro breastfeeding monitor from concept to functional prototype, and achieved the production-ready stage after successful validation of the technology in clinical trials.
The main challenge was the identification of an innovative micro-flow sensing technology capable of capturing the signal dynamics of breastfeeding milk flow, never measured directly and consistently before. A second challenge was the integration in a standard nipple shield of the sensor and processing electronics, which required extensive research for the identification of appropriate materials and manufacturing methods, leading to the development of different prototypes before the establishment of a final design.
Only food and medical grade materials were selected, and thorough testing was performed to deliver a product safe for daily use by breastfeeding mothers. Before the release in clinical trials, Coroflo obtained the EU CE mark after testing Coro for food-contact safety, Electromagnetic Compatibility (EMC) and radio emissions. Cleaning validation was performed before the release in clinical trials. Coroflo also registered as a member company of Bluetooth SIG.
Within the project duration, IP protection of the trademark and of the micro-flow sensing technology was achieved in Europe, US, China and Japan, and will continue to be pursued in these regions.
With the design of the functional prototype finalised and the sensing technology validated, the manufacturing partner for production was identified and contracted. Tooling design and production was completed and the first samples of the device were produced and inspected for functionality, however, further improvements of some production steps are still required.
The sensing technology was validated in a rigorous clinical trial with breastfeeding mothers in partnership with RCSI (Royal College of Surgeons in Ireland), successfully completed over the course of the project. Feedback gathered by the researchers was positive in terms of device acceptability. Results from the tests performed in 2021 were published at PAS 2022 conference (https://2022.pas-meeting.org/fsPopup.asp?Mode=posterinfo&PosterID=480846). Results from the tests performed in 2023 are currently under review and being prepared for publication. Coroflo is delighted to be able to continue to maintain this and new research relationships with further studies building on the excellent outcomes to date.
The main challenge was the identification of an innovative micro-flow sensing technology capable of capturing the signal dynamics of breastfeeding milk flow, never measured directly and consistently before. A second challenge was the integration in a standard nipple shield of the sensor and processing electronics, which required extensive research for the identification of appropriate materials and manufacturing methods, leading to the development of different prototypes before the establishment of a final design.
Only food and medical grade materials were selected, and thorough testing was performed to deliver a product safe for daily use by breastfeeding mothers. Before the release in clinical trials, Coroflo obtained the EU CE mark after testing Coro for food-contact safety, Electromagnetic Compatibility (EMC) and radio emissions. Cleaning validation was performed before the release in clinical trials. Coroflo also registered as a member company of Bluetooth SIG.
Within the project duration, IP protection of the trademark and of the micro-flow sensing technology was achieved in Europe, US, China and Japan, and will continue to be pursued in these regions.
With the design of the functional prototype finalised and the sensing technology validated, the manufacturing partner for production was identified and contracted. Tooling design and production was completed and the first samples of the device were produced and inspected for functionality, however, further improvements of some production steps are still required.
The sensing technology was validated in a rigorous clinical trial with breastfeeding mothers in partnership with RCSI (Royal College of Surgeons in Ireland), successfully completed over the course of the project. Feedback gathered by the researchers was positive in terms of device acceptability. Results from the tests performed in 2021 were published at PAS 2022 conference (https://2022.pas-meeting.org/fsPopup.asp?Mode=posterinfo&PosterID=480846). Results from the tests performed in 2023 are currently under review and being prepared for publication. Coroflo is delighted to be able to continue to maintain this and new research relationships with further studies building on the excellent outcomes to date.
The state-of-the-art in breastfeeding monitoring may be broken down into 3 technical categories: 1)Offline indirect: no connectivity nor direct measure of milk flow; 2)Real-time indirect: connectivity, no direct measure of milk flow; 3)Real-time direct: connectivity, direct measure of milk flow.
There have been many attempts to develop all of these approaches to date but none have achieved market traction or credibility with the breastfeeding professional community, nor with breastfeeding mothers, nor in the clinical or research world primarily due to demonstrable lack of accuracy or inability to apply the technology in a miniaturized state to be feasible for use.
Coro is the only conceptually viable, and now implemented, solution to accurate breastfeeding monitoring. It is the only real-time, user friendly, direct and most crucially, proven accurate technology.
The impact of the results published to date is evident, with multiple breastfeeding research groups ready to use Coro in their studies for exploring the vast immunological potential of breastmilk, assessing the potential lifelong impact of breastfeeding on neurodevelopment, with accurate volume transfer of breastmilk a crucial missing piece to date. Coro will, as hoped, add substantially to the knowledge bank in the area of breastfeeding medicine.
Breast milk is naturally produced by the human body, is nutritious, and has immune system-modulating and disease-preventative properties but, unfortunately, due to concerns regarding milk supply, is often replaced with commercially produced nutrition. On an individual level Coro can now eliminate the foremost reason for discontinuation of breastfeeding, and provide each mother with data to make informed decisions in their breastfeeding path with potentially global impact.
The environmental impact of Coro is clear when considering that for the production of 1kg of breastmilk-substitute powder more than 4000L of water are needed, and all the waste related to packaging ends up in landfills. On the contrary, breast milk is a “natural, renewable food” and environmentally safe.
There have been many attempts to develop all of these approaches to date but none have achieved market traction or credibility with the breastfeeding professional community, nor with breastfeeding mothers, nor in the clinical or research world primarily due to demonstrable lack of accuracy or inability to apply the technology in a miniaturized state to be feasible for use.
Coro is the only conceptually viable, and now implemented, solution to accurate breastfeeding monitoring. It is the only real-time, user friendly, direct and most crucially, proven accurate technology.
The impact of the results published to date is evident, with multiple breastfeeding research groups ready to use Coro in their studies for exploring the vast immunological potential of breastmilk, assessing the potential lifelong impact of breastfeeding on neurodevelopment, with accurate volume transfer of breastmilk a crucial missing piece to date. Coro will, as hoped, add substantially to the knowledge bank in the area of breastfeeding medicine.
Breast milk is naturally produced by the human body, is nutritious, and has immune system-modulating and disease-preventative properties but, unfortunately, due to concerns regarding milk supply, is often replaced with commercially produced nutrition. On an individual level Coro can now eliminate the foremost reason for discontinuation of breastfeeding, and provide each mother with data to make informed decisions in their breastfeeding path with potentially global impact.
The environmental impact of Coro is clear when considering that for the production of 1kg of breastmilk-substitute powder more than 4000L of water are needed, and all the waste related to packaging ends up in landfills. On the contrary, breast milk is a “natural, renewable food” and environmentally safe.