Precise brain oxygen monitoring for high-risk preterm infants

Información del proyecto

OXYPREM

Identificador del acuerdo de subvención: 888943

DOI

10.3030/888943

Proyecto cerrado

Fecha de la firma de la CE 22 Noviembre 2019

Fecha de inicio 1 Noviembre 2019

Fecha de finalización 29 Febrero 2020

Financiado con arreglo a

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Coste total

€ 71 429,00

Aportación de la UE

€ 50 000,00

Coordinado por

OXYPREM AG
Switzerland

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

Período documentado: 2019-11-01 hasta 2020-02-29

Resumen del contexto y de los objetivos generales del proyecto

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.

Trabajo realizado desde el comienzo del proyecto hasta el final del período abarcado por el informe y los principales resultados hasta la fecha

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.

Avances que van más allá del estado de la técnica e impacto potencial esperado (incluida la repercusión socioeconómica y las implicaciones sociales más amplias del proyecto hasta la fecha)

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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