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A new innovative method for diabetes treatment, the artificial pancreas system

Periodic Reporting for period 1 - MedicSen (A new innovative method for diabetes treatment, the artificial pancreas system)

Reporting period: 2017-08-01 to 2018-01-31

There is a very well-known worldwide problem in the management of chronic diseases and high costs associated to its control resulting in a poor service. There is also evidence which suggests that there is a correlation between sedentary lifestyle and the prevalence of chronic diseases, such as diabetes. One of the greatest challenges associated with lifestyle diseases is the demand for real-time monitoring of various physiological markers which include blood pressure and blood sugar levels. Diabetes patients are particularly dependent on up-to-date data because routine tracking is an inherent part of living with the disease, which is accompanied by stressful trigger points during which health and psychological needs go in parallel. The ability to log and enter relevant data, whether manually or automatically (via smartphones, tablets or computers), and to update or change information in real time, enables diabetes patients to have greater control over their condition. Diabetes is one of the main existing and growing chronic diseases and according to IDF (International Diabetes Federation) Atlas 8th edition there're over 420 million people between 20 and 79 years old living with diabetes in 2017. The evolution on healthcare expenditure in diabetes has been tremendous, growing from USD 232 billion spent by people with diabetes worldwide in 2007, to USD 727 billion in 2017 only on healthcare which corresponds to one for every eight dollars spent on healthcare (12% of global health expenditure). Moreover approximately 4.0 million people aged between 20 and 79 years are estimated to die from diabetes in 2017, which is equivalent to one death every eight seconds. Medicsen has developed an app that fits perfectly in the European market, in which healthcare providers will benefit from cost reduction and an increase in the quality of their services, initially for patients with diabetes but adapting it later on to other diseases and healthcare problems relevant for the region (high blood pressure, general lifestyle management, epilepsy...). With the decisions we have made in 2017, we believe to have created a solid platform for the sustainable, long-term growth of Medicsen. In 2018, we will focus on implementing the strategies we have developed and started executing in 2017. The increase in the number of people with chronic diseases such as diabetes and the cost of treating them put healthcare budgets under pressure. Therefore, we expect a modest growth on sales in 2018, as we progressively position in order to gain market share for the app while we continue on testing and validating the smartpatch technology in order to be commercialized during 2020.
Medicsen seeks both public and private funding to achieve the milestones mentioned above, up to EUR 4 million during 2018 & 2019, which will allow us not only to attract and hire talent but also to achieve continuous improvement in terms of development, quality control, regulatory aspects and commercial relations.
Since the beginning of 2017 Medicsen achieved several goals in terms of innovation and business development, some of the most relevant are:

January: Alpha version of the App with chatbot interface implemented on the mobile app and security tests ongoing; IPR application accepted and subject to final approval.
March 2017: Beta version of the APP. Artificial Intelligence was added to the App to enlarge the communication with the user and pattern recognition.
April 2017: Beta Testing targeting 500-1000 early users as a field test to fix any remaining debugs and prepare the final version of the APP for future release; Collaboration with a Spanish Hospital (H. de Cruces) to adapt the App to healthy habits and prevention to be tested locally.
May 2017: 300 Beta testers within the first 4 weeks, about 90% of them make regular use of the App on a daily basis.
June 2017: Alpha version of the HW that demonstrates skin stimulation up to a certain level, allowing insulin to surpass skin barrier.
August 2017: Selected to participate in the HotDesQ program, funded and hosted by the Australian Ministry of Innovation, from October 2017 until April 2018 to access that market.
October 2017: Completion of Beta testing successfully, managed to reach over 700 beta testers who helped solving debugs and improve the functionalities of the system; Selected to participate in Merck’s 4 month accelerator program in Germany to seek for potential collaboration on diabetes treatment
November 2017: SW Alpha version release to the Play Store. Free version working on Android devices. Roughly EUR 35.000 was invested on product design and development; Closed a bridge financing round of EUR 260.000 split in two tranches, first tranche was fully covered (EUR 160.000) and second tranche is expected to close in Q2 2018.
December 2017: Chose B2B-C as our main business model for monetizing the App in the short term and started talks with several private healthcare providers interested on implementing MEDICSEN´s solution
Roughly attained over 400 active users of the App by the end of December 2017.

Fiscal year 2017 marked Medicsen's third year since its foundation as a company, and we are pleased with the progress we are making to improve healthcare treatments and take them to the next level of efficiency, integration and respect for the quality of life. We remain committed to our mission and are incredibly inspired by it, which is to improve the quality of life for patients with diabetes by tailoring the treatment to eachperson and their unique condition.
Progress beyond the state of the art:

Funding achieved: €320K in two rounds; Just closed a €270K round at a €2M valuation.
More than €240K in grants in the last 12 months.
App: tested with 100 patients for validation and development (plus doctors), now we have more than 1000 early adopters with more than 400 active users.
Algorithm: less than 8mg/dl as mean error when forecasting 1 hour glucose levels; Insulin smartpatch: insulin molecule went through pork skin with 6 minutes of patch application; increases permeability to insulin up to 50 times.
PCT international patent.
Committed team of more than 15 members.

Roadmap and future goals

APP Premium (+Marketing); Patch laboratory tests (absorption rates)
Insulin dosage + big data (algorithm); Patch final design and regulatory strategy
Increase cyber security; IOS; Start of Series A fundraising; Chat-bot intelligence
USA internationalization strategy, increase SW functionalities (and integrations)
SW pilot tests results and closing of B2B agreements; 5000 users
Patch Beta prototype ready for human testing, start of manufacturing

Expected impact

Only 35% of the patients achieve the target goals;with 420M it consumes between 10 and 20% of annual health Budget
MedicSen´s social impact is mostly measured in terms of quality of life, treatment adherence and thus less costs.
Improvement in treatment adherence: 2018 (10%) 2020 (30%)
Decrease in HbA1c: 2018 (-5% point) 2020 (-15%)
Decrease in complication rate: 2018 (-1%) 2020 (-5%)
Revenue: 2018 ($150K) 2020 ($10M)
Jobs: Year 2018 (15) 2020 (51)
Institutional clients: 2018 (1) 2020 (10)