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.
