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Precise brain oxygen monitoring for high-risk preterm infants

Periodic Reporting for period 1 - OXYPREM (Precise brain oxygen monitoring for high-risk preterm infants)

Reporting period: 2019-11-01 to 2020-02-29

The proposed innovation addresses the well-established problem reported by neonatologists related to the lack of reliable and accurate tissue oximeters for babies born prior to gestational week 37, preterm babies. These patients need continuous oxygen level monitoring to avoid health-related complications and even death.
Preterm livebirth accounts for 10% of all, nearly 500,000 livebirths just within Europe. It is the leading cause of death for neonates, with up to 34% of surviving ones facing lifetime disabilities like cerebral palsy, paralysis, visual impairment and premature young adult death.
OxyPrem AG has carried out a 4-month feasibility study accomplishing three objectives: 1) Technical objective: Review the specifications of the OxyPrem hardware (HW) and software (SW), defining the actions needed to make preterm's oxygen monitoring more accurate and reliable; optimize our proprietary algorithm/SW that processes the signals measured by the sensor. We have prepared an Execution Plan for the development of OxyPrem, including planning, organization, risk analysis and detailed budget. 2) Commercial objective: We have elaborated a commercialisation plan, including a market study quantifying the number of potential end-users and market size (number of neonatal intensive care beds in Europe and US) for the OxyPrem medical device. We have conducted an interviewing process with European specialized distribution companies to determine how appealing is OxyPrem as a commercial product, with a highly satisfactory outcome. A Freedom To Operate Analysis (FTO) has been carried out to avoid barriers regarding IP in our target countries. 3) Financial objective: We have elaborated a solid financial plan of the project, including a 5-year-projection forecast, using as backbone the marketing and price strategy that we have built for OxyPrem. As a conclusion, given the technical and commercial feasibility of the project, we have decided to continue with the product development and will request further support to the EIC.
As of now, we have a working tissue oximeter (TRL7) which has undergone several iterations and has been confirmed to perform as intended in actual hospitals and preterm babies. The current OxyPrem has recently been cleared by the EC, obtaining the MDD CE mark. Once the project is completed, we expect to have an optimized version of OxyPrem ready to be commercialized within Europe (having the MDR CE mark) and the US (once the 510k certification is obtained). Furthermore, we will implement the final manufacturing process to produce the tissue oximeter at scale to cover an expected demand of units during the 5 years of commercial activities. A dissemination strategy including both off-line and on-line activities including the attendance to specialized neonatal conferences and events will be deployed to create awareness among the neonatology community.
Once completed, OxyPrem will enable neonatal intensive care unit personnel to timely and reliably identify potentially deleterious oxygen cerebral levels, avoiding the occurrence of irreversible damage leading to chronic conditions or even the death of preterm babies. It will furthermore greatly reduce the rate of false alarms, consequence of false positives due to confounding variables such as movement of the baby.
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