Periodic Reporting for period 1 - BabyLux (Launching the First Non-Invasive Brain-Monitoring System for the Early Detection and Management of Encephalopathy In Preterm Babies) Reporting period: 2017-01-01 to 2017-05-31 Summary of the context and overall objectives of the project Prematurity is the leading cause of death of children under 5 years of age worldwide and those who survive, show higher risk of brain injury resulting in life-long physical, neurological, or educational disability, often at great cost to families and society. Apart from the human costs, prematurity bears an economic burden which has been estimated to amount more than $26 billion annually. Hypoxic-Ischemic Encephalopathy is one of the most common forms of brain injury in preterm infants, who show an increased frequency of events potentially causing hypoperfusion and have a relatively poor autoregulatory capacity of the premature brain. To detect cerebral damage at an early stage and implement suitable treatments (e.g. oxygen therapy through mechanical ventilation), oxygen saturation and blood flow in the brain need to be measured in real-time and accurately right after the neonate’s birth. BABYLUX measures brain oxygen saturation and a relative index of blood flow in an accurate, continuous, safe and non-invasive way by means of advanced near-infrared photonic technology. At HemoPhotonics, S.L. we are committed to further develop the current BABYLUX prototype into a mature device ready to enter the neonatology market. Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far During phase 1, a feasibility study of the commercialization of BABYLUX has been carried out. It addresses the technical upgrades and regulatory requirements in view of a commercialization of the current prototype, thereby culminating the development of a European technology by bringing to the market a novel concept developed under a European funded programme. In parallel, a thorough analysis of the commercial aspects required for the success of this venture has been performed. Thus, the target market and the freedom to operate in it have been analysed. Furthermore, a suitable business model has been put forward together with a financial analysis of the commercialization of BABYLUX in the mid- and long-term. All these aspects have been reflected in the corresponding business and work plans. 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) The problem of monitoring brain oxygenation and blood flow remains unsolved since current commercial solutions provide partial measurements or are extremely invasive. BABYLUX thus represents the first non-invasive brain-monitoring system for the early detection and management of encephalopathy in preterm babies. By achieving the above-mentioned goals, we contribute to the European leadership in enabling and industrial technologies. More specifically, the BABYLUX neuromonitor is intended for neonates, especially extremely preterm ones, whose risk of developing life-long neurological impairment is, at present, unacceptably high. Therefore, its market introduction is additionally in line with the health and well-being Societal Challenge of the H2020 by minimizing the societal and economic burden associated to the increasing number of premature births. smeinst-logo-hemophotonics.png
