Periodic Reporting for period 1 - RBM-Screen (Professional Urinary Screening) Reporting period: 2017-06-01 to 2017-10-31 Summary of the context and overall objectives of the project • Problems addressed by RBM-ScreenIt is necessary to obtain accurate measurements of the state of the renal before a physician can diagnose and consequently provide treatment to the patient. The need to monitor and follow the kidney function is significant and involves patient, practitioner and hospital. In our initial studies, we have discovered that the patients are only slightly involved in the treatment and in responds to potential symptoms the clinicians take over. The reason for this is, that the patients do not have the tools at disposal that can categorize and validate those symptoms and hereby benefit of patient involvement and empowerment. The main idea with RBM-Screen is an early warning system of renal complications or failures with the aim to provide the most efficient treatment or prevent hospitalization if it is a false alarm. On one side the RBM-Screen device for both clinics and practitioners and on the other side for former renal patient at home offering the possibility to monitor in real-time the biomarkers in urine and variations in volume and establish an indication of potential renal failures or dysfunctions. • RBM-Screen and the importance for society?The global focus is on one hand to reduce costs of treatments at hospitals by reducing number of occupied beds and in general avoid hospitalization and readmission by empowering practitioners to screen urine and private home self-screening and on the other hand to improve patient literacy, empowerment and involvement by giving the patients tools for self-monitoring and data handling in close connection with practitioners and hospitals. With RBM-Screen we address the following main societal problems:- The pressure on hospitals budgets worldwide is growing, which forces management to focus on cost reductions.- It is stated international to improve patient literacy, empowerment and involvement, which demands relevant content in already existing data system/infrastructure to make it possible for the patient to take care of self- treatment and follow up.- The need of improved content in the existing infrastructure is essential; a possible improvement should be in literacy and to avoid unneeded hospitalization is global.- Not being able to continuously monitor the renal system of patients, gives a decline in general welfare and creates uncertainty • The overall objectives for RBM-ScreenThe purpose of RBM-Screen is to strengthen patient involvement, literacy and empowerment, avoid unneeded hospitalization and consultations, reduce overall cost and improve treatment by using the RBM-Screen devices. Therefore, our goal is to commercialize a mobile Renal Bio-Marker Screening (RBM-Screen) device; firstly, for the use of practitioners and clinics and secondly for patients’ self-control in close dialog with practitioners to give the right picture and warning of upcoming renal failures or dysfunctionalities. The device can detect the most important biomarkers in urine, which are connected to the functionality of the renal system with the primary purpose of: (i) Improve treatment speed and quality by giving temporal resolution. (ii) Reduce treatment cost by avoiding unnecessary hospitalization. (iii) Reduce patient’s inconvenience and thus support the objective of strengthening empowerment, literacy and involvement in patient care. The next step according to our conclusions of action is that the market is ready for RBM-Screen, we are apple to fulfill the technical requirements for the device and we will go into next step of commercialization of RBM-Screen. Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far Further market studies were conducted to identify, and solve eventually challenges in the market introduction of the RBM-Screen device, hereunder market up-take issues, unique selling points and strategic partnerships.Result of interviewed physicians pointed out, that the pressure on hospital budgets and the increasing cost per bed day forces the hospitals to find new ways of avoiding hospitalization, by supporting self-treatment, self-monitoring, empowerment and therefore reliable devises placed on patient location in close cooperation primary with practitioners and secondary with hospitals.The result of interviews with former patients pointed out the need to reduce false alarms and herewith reduce fear and uncertainty. Today former patients often have direct contact with hospitals and get by symptoms hospitalized, even if it’s known that a large number of hospitalization of former patients (according to interview) are false alarms.In exploring alternative spectroscopic method for optimal device design many experiments were performed in collaboration with Danish Technological Institute (DTI). There is good evidence to make a RBM-Screen device with fast and low detection level, when comparing to physiological concentrations of the pure compounds in aqueous solution using our spectroscopy method.A thought-out development plan towards the final RBM-screen device was conducted, including identification and establishment of partnership with component manufacturers, clarifying ISO certification issues and IP management.This development plan was hereafter described in several WPs, which has to be done in the innovation project hereafter, including description of tests and observation studies on different locations under existing work flow conditions with patient’s involvement, prototyping processes, user interface requirements, tests for reliability, prediction of cost and time saving impacts and infrastructure for information flow. 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) RBM-Screen will be a first mover to a market with an enormous unexploited potential. The problem and the requirements are well known, but currently there is no easy and reliable solution either for professional practitioners or for personal use. The main market barriers faced by RBM-Screen is the risk of some inertia in the market uptake, which we will meet with a validated blue print of reliability and a thorough documentation of the significant benefits compared to the todays solutions or absence of those, i.e. a convincing value for money approach. The market potential in EU for RBM-Screen amounts to over 500 Mill. € from sales to the 2 main target groups. Moreover, the net cost savings for the society amounts to nearly 600 mill.€ according to primary avoidable bed-days. We have not included saved cost of a lower mortality rate or reduced cost by preventing renal failure. Furthermore, our B2C target group only focus on former patients (conservative estimate) and not all disposed patients. As reported by the official reports the problem has worsens; the societies international faces a 5-8 % yearly increase. We therefore conclude that the company RBM-Screen will face a high volume and growing market in the coming decades, mainly because of the increasing need for a reliable, real-time and easy-to-use device for B2B and B2C. Today, no real-time, constant monitoring is available in any temporal capacity. Therefore, no decentralized self-control or practitioners control are currently present, because the tool has not yet been developed and launched. We have developed a first mover product, which makes it possible to reduce uncertainty, inconvenience and give the clinicians a real possibility to optimize treatment of renal and former renal patients and furthermore substantial reduce the cost of treatment and as importantly reduce mortality rate of patients. Hereby reduce the risk of a decline in general welfare.The device, which could fulfill the outline above, is cost efficient, easy to use and minimized. It can fit into clinics and later in the private sphere. Such a solution is RBM-Screen. It gives a reliable real-time detection of biomarkers and thereby the means to proper and timely treatment.