Clinical validation of pCO2 sensor system for ischemia detection

Project Information

CLINISC

Grant agreement ID: 672444

DOI

10.3030/672444

Project closed

EC signature date 15 April 2015

Start date 1 May 2015

End date 31 October 2015

Funded under

• SOCIETAL CHALLENGES - Health, demographic change and well-being

Total cost

€ 71 429,00

EU contribution

€ 50 000,00

Coordinated by

SENSOCURE AS
Norway

Periodic Reporting for period 1 - CLINISC (Clinical validation of pCO2 sensor system for ischemia detection)

Reporting period: 2015-05-01 to 2015-10-31

Summary of the context and overall objectives of the project

Sensocure AS is a company with major ambitions in the development and delivery of sensors for medical use. New medical technology developed by the company will be a breakthrough in real-time monitoring of body functions and early detection of organ damage. Insufficient blood supply to vital organs (ischemia) is the most common cause of death in the Western world in terms of stroke, myocardial infarction, trauma, complications after surgery and a variety of other conditions. There is therefore a great need for diagnostics that can trigger early treatment in this area. Sensocure has developed and patented an innovative biomedical carbon dioxide (CO2) sensor (IscAlert™) designed for the earliest possible detection of ischemia.

A business plan has been elaborated in the Phase I feasibility study. The plan defines the various market segments and defines pros and cons for using specific markets for the launch of the IscAlert product.

The aim of the business plan is to validate the sensor system through a number of clinical tests. The validation of the system will involve the key users of the IscAlert product.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

During the feasibility study Sensocure has prepared the ethical and legal framework needed for the clinical testing. The result of this work is a detailed clinical test plan describing the kind of surgery to be monitored, the clinics to be used, the number and kind of human patients to be addressed, the legal approval procedures and a time schedule for the said tests

As part of the feasibility study Sensocure has made a market survey identifying the market potential by means of number of annual procedures benefitting from ischemia sensing. The feasibility study reveals that the first segments to target are reconstructive surgery followed by peripheral vascular, amputations and limb compartments (the current sensor system is already CE/FDA approved for these areas). The survey also included an analysis on End user sales (MEUR) for various diseases.

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)

The benefits for the users can be measured along two lines:
• The hospital gets a monitoring system that improves their efficiency by means of throughput and first time right surgeries.
• The society gets reduced morbidity and mortality, and thereby cost of care, for ischemia related diseases. It fits well into current medical practice by giving improved patient outcome and therefore substantially reduces healthcare costs by lowering the need for e.g. intensive care.

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