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Cardiovascular Diseases Diagnoses by means of Smart Remote Monitoring System based on known Heart Activity Biomarkers

Periodic Reporting for period 1 - HELMO (Cardiovascular Diseases Diagnoses by means of Smart Remote Monitoring System based on known Heart Activity Biomarkers)

Reporting period: 2015-05-01 to 2015-08-31

"The project HELMO aims at developing and clinically validating a no-invasive remote monitoring medical device for the early diagnoses of cardio vascular diseases (CVD) based on identified biomarkers and hence, to foresee critical events and to provide assistance before fatal consequences, even death. The product will be designed, engineered and industrialized by XEOS company together with a strategic partner SENSING TEX (SENSING) subcontractors and collaborations.
Globally, CVD remains the leading global cause of death, accounting for 2,3% of deaths or 17,3 million deaths per year, a number that is expected to grow to >23,6 million by 2030 . In Europe, CVD accounts for more than 40% of deaths or 2 million deaths per year, as documented online by the EU .
The high prevalence of CVD entails a large financial burden affecting to patients and to National Health Systems. Overall CVD has major economic costs as well as heavy casualties in every country in Europe. Overall CVD is estimated to cost the EU economy almost €196 billion a year. . These figures represent a cost per capita of €212 per annum, around 9% of the total health care expenditure across the EU. Currently, EU health problems cannot deal with this worsen situation and the need to reduce risks for suffering CVD fatal episode and allowing users to get tailored treatment with a daily monitoring minimizing the impact of their daily life is became evident. Moreover, it is also clear that there is an economic demand to implement cost effective measures to early identify CVD risks and symptoms, as well as innovative monitoring systems. Thus, XEOS and SENSING are determined to reduce preventing these increasing social diseases with HELMO, a no-invasive remote monitoring medical device for the early diagnoses of cardio vascular diseases (CVD).
HELMO main objective is to develop a high tech and disruptive T-shirt able to monitor 10 vital parameters providing real time alerts from intelligent algorithms to both clinicians and patients. The main advantages are ergonomics, portability and multi-parametric approach of wearables together with the high accuracy of medical equipment.
The followings list the objectives and the expected outcome which will be achieved within the Phase II to launch the final product HELMO on the market through the innovation business project planned by the Consortium:
• To develop a smart T-shirt made of conductive inks able to acquire and transmit data from 10 vital parameters identified as biomarkers of CVD pathologies: ""12 leads"" ECG, heart and breath rate, body movement and posture, temperature, sweat, calories burnt, location and additionally blood pressure and oxygen saturation
• To optimize and implement the final mobile application and cloud platform which run the intelligent algorithms able to identify biomarkers threshold tailored for each patient and activate the alarm system
• To perform an clinical validation which shows the efficacy of the HELMO versus current CVD monitoring systems and allow us to obtain the CE/FDA certification
• Optimizing and pre-commercialize the new product HELMO to be ready to face market competition
• Patenting the new product HELMO and obtaining Medical Certifications (CE, FDA) of the new electro-medical device
There were three major tasks blocks in this feasibility study: technical, financial and business plan. The work performed has been focused on study the technical and financial feasibility of our project as well as to create realistic business plan for the following 5 years. The results of that work, carried out during the past 4 months, have been compiled in one document, a Feasbiligy Study which results can summaried as follows:
• Market: in-depth analysis of the market size (potential and targeted markets), trends and forecasts which reveal a potential market of aprox. 18 millon patients of CVD and an growing Health Wearable Market over € 2 billion in Europe
• Competitors analysis: we have analyzed the competitors landscape concluding that HELMO will provide a competitive advantage being the unique wearable device able to monitor ECG 12 leads and other 9 vital parameter at real time proving alerts direct to the physicians.
• Work plan: we present a detailed work plan and related risk contingency plan which steps must be undertaken in order to develop and clinically validate the final product: smart T-shirt and its complements.
• Business Plan and Financials projections: we have performed a market forecast which will allow us to sell over 50,000 units by 2022, as well as internationalized the company across Europe and US.
In the Feasibility Study we have studied carefully the significant impact of HELMO on both: company growth and European Health Systems. Our market projections ensure that we will be able to obtain over accumulative revenues of €33 million by 2022, what means a market penetration of 0.16%. After 5 selling years, we will reach a ROI of 729, meaning that we will generate 7,29€ per each euro invested.
Nevertheless, HELMO will have a significant social and economic impact in Europe since by 2022 ,more than 130.000 discharge patients will be remotely monitored through HELMO decreasing the costs related to hospitalizations and improving the quality of life by reducing the risk of suffering fatal events. In fact the main impacts for Public and Private Health systems will be:
• Savings up to 80% in the diagnosis and treatments for patients or high risk population
• Reduction up to 15% the patients hospitalized
• Decrease in 60% the emergency department attention rate.