Clinical validation of pCO2 ischemia sensor

Sensocure has developed and patented a biomedical sensor (IscAlert) designed for the earliest possible detection of ischemia, through measurement of the biomarker carbon dioxide (CO2). Ischemia is a condition where the cells do not get enough oxygen to survive because of inadequate blood supply. Ischemia is the most common cause of death in the Western world. Sensocures body-implantable micro biosensor IscAlert can monitor blood flow in the human body organs, and will be a breakthrough in real-time monitoring of body functions and early detection of organ damages caused by insufficient blood supply to organs. The sensor is easy to use and has applications in e.g. cardiac surgery, vascular surgery, transplant surgery, reconstructive surgery and in trauma and cardiac arrest victims. The sensor technology is patented in many parts of the world and the first version of the sensor has received CE marking and FDA approval. The current sensor system is categorized as TRL 7: System prototype demonstration in operational environment. The prototype has been used in animal testing with reliable and promising results. In this EIC Accelerator pilot Sensocure wants to move the IscAlert prototype from animal testing to human clinical testing and at the same time extend the number of EU based hospitals gaining experience with the real time measuring system. The company has created a business plan and a plan for the clinical testing of the IscAlert sensor on human patients. Clinical testing will be organized in cooperation with four European University Hospitals in Uppsala (SE), Brussels (BE), Zürich (CH) and Oslo (NO). Sensocure has also 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.