Periodic Reporting for period 3 - GlucoBeam (GlucoBeam: A portable device for pain-free glucose self-monitoring in diabetic patients) Período documentado: 2020-12-01 hasta 2021-09-30 Resumen del contexto y de los objetivos generales del proyecto Diabetes mellitus (DM) is one of the largest health challenges currently faced by modern society, affecting over 400 million people in the world. DM cannot be cured, but via well-controlled therapy, a high quality of life with diabetes can be obtained, with a minimum of short- and long-term complications. The key to a successful diabetes therapy is a well-controlled blood glucose level, which is obtained by carefully balancing insulin intake, diet, and exercise and with Self-Monitoring of Blood Glucose (SMBG) as a cornerstone. Conventional SMBG is an invasive test requiring the patient to prick his/her finger with a lancet to extract a blood droplet onto a disposable strip for electrochemical analysis of the glucose concentration. Repeating this uncomfortable and painful task 4-8 times per day leads to severe loss in life quality, often resulting in poor compliance leading to costly complications.RSP’s proprietary non-invasive SMBG technology relies on the capabilities of Raman spectroscopy for directly detecting individual substances, refined by a unique critical depth optical scanning to collect glucose signals from the right tissue depth range, thus avoiding sources of errors during the measurement. Our device will enable DM patients to test their glucose levels in around 30 seconds and as often as desired – at no added cost or pain – thereby empowering them to better manage their treatment and minimizing the risk for acute complications.The overall objective of the project is to undertake all required miniaturization activities to transform RSP System’s current tabletop prototype for non-invasive glucose monitoring into a lunchbox-sized system and demonstrate its performance in a large clinical trial to thoroughly document its performance. In addition, the project focus on preparing for commercial exploitation, which will enable RSP systems to penetrate the multi-billion diabetes glucose monitoring market. Trabajo realizado desde el comienzo del proyecto hasta el final del período abarcado por el informe y los principales resultados hasta la fecha The GlucoBeam project, partially funded by the Horizon 2020 SME instrument, started in March 2017 with the aim to provide a portable device for pain-free glucose self-monitoring. In 2017 the Company had already demonstrated its technology’s ability to measure glucose employing the critical depth technology, devised by RSP and had the technology patent protected worldwide. The technology had been demonstrated using a table-sized device, notconvenient for home use. Therefore, the main goal of the project was to miniaturize the device while maintaining or improving the performance in terms of MARD, and prepare such device for pilot testing and market approval in EU. The performance measure Mean Absolute Relative Difference (MARD) is used by the industry and is based on the comparison between paired measurements of the GlucoBeam system and a reference method.During the past year, the Company has had a thorough market analysis performed by a top management consultancy firm, pointing the Company towards the US digital health segment for its first iteration of GlucoBeam. Obesity derived from diabetes is a huge and growing challenge worldwide, causing both monetary and personal distress. Existing devices used for glucose management are invasive and thereby not attractive for pre-diabetics. GlucoBeam is a non-invasive application appealing to prediabetics and general population, giving people important information about one of the most important indicators of health – glucose level. The digital health opportunity has led to a shift in the Company’s strategy, postponing European market approval and instead initiated preparation of GlucoBeam for US market entry, implying compliance with US 21 CFR 820. Nevertheless, the Company has, supported by resources added by the Horizon 2020 program, in May 2018 achieved ISO13485 certification, and the Company is therefore well-prepared for market approval in EU, after approval in the US has been reached.Furthermore, Company has achieved major and unexpectedly good device calibration improvements during the past five years. The Company has demonstrated that calibration of the device will last for a very long time, which allows subjects to use the equipment for a very long time, and with a very good stability. This implies taking reference measurements for a short period - thereby avoiding the pain related to finger pricking in several weeks after calibration. The Company has also become confident that it will be able to achieve factory calibration, where one device can be used by many users, and where calibration relies solely on data from a pool of calibration information provided by many users.During 2021 the Company has used GlucoBeam in its hitherto largest clinical trial, involving more than 150 devices in a multicenter trial in Germany and Denmark. The clinical trial has contributed to the above-mentioned improvements in accuracy and calibration stability, and results from the trial show robust overall performance, and show that demographic variation e.g. gender, age, skin type (color) had no discernable influence on the device performance.Additional to the Horizon 2020 grant, the Company has, during the project period from 2017 to 2021 in its Series B - and in the open Series C - round, raised almost EUR 20 million in equity from private investors and venture capital. The Company aims to close its Series C round in May 2021 at a total EUR 15 million, bringing total funding to EUR 41 million. 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) The project has the potential to impact health care systems by increasing patience compliance, thus lowering the costs of complications and reducing the loss of societal earnings. The direct impact counts both physical and physiological factors, for the patient and his/her surroundings. It goes from bettering the patients finger condition, to helping him/her achieving better metabolic control and increased compliance, to helping families take care of their children and elders through pain free measurements.Our strategy to bring an adjunctive device to the market allows both to shorten time-to-market and to rapidly monetize our disruptive technology, empowering RSP to cover its medium term innovation strategy. In sum, our non-invasive device is targeted at a billion global market and its commercialization will represent an aggregate turnover of approx. €253 million over the 5 years post-project. It has the potential to reach double digit billion savings for EU healthcare system and will lead to significantly improved life quality for diabetes patients. glucobeam-med-hand-ny-lille.jpg picture-of-device.png glucobeam-5-ny-lille.jpg
