Periodic Reporting for period 1 - CIRDvalid (CIRDvalid – Clinical validation of a set of 11 biomarkers and a system of diagnostic and therapeutical devices for the resuscitation of patients suffering from long-lasting cardiac arrest)
Reporting period: 2015-06-01 to 2015-09-30
For decades there has been no significant improvement in resuscitation-therapy. Only 3% survive out-of-hospital and only 18% survive in-hospital resuscitation. The time-frame for a successful resuscitation is only about 3 to 5 minutes after cardiac arrest. To increase this time-frame significantly ResuSciTec has developed a new therapeutical concept to induce a paradigmatic shift in resuscitation therapy. This new concept has been validated in animal studies. ResuSciTec has produced proof of concept in preclinical animal studies for successful resuscitation after 20 minutes of cardiac arrest. About 90% of the animals (pigs) survive without or nearly without neurological damage. To perform this new therapy ResuSciTec has developed an innovative therapeutical system called “CIRD - Controlled Integrated Resuscitation Device”.
Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far
The following tasks had to be addressed: (1) Clinical: (a) Design and planning of the extended clinical validation of the biomarkers (b) Identification of 10 to 15 clinical centres in the EU for the performance of clinical-study after CE-Approval (2) Technological and Regulatory: (a) Verification and Validation-Planning for BioM-11 Device and the CIRD system (c) Design-FMEA in conformity to EN ISO 14971 (d) Roadmap to certification (CE, FDA, Japan) (3) Economic: (a) Elaboration of a business-plan for the years 2016 to 2021 which is clear with measurable realistic milestones within the duration of the project including an economic risk assessment, a market study, a roadmap for the reimbursement of the therapy in European countries.
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 overall innovation project has four objectives: (1) Clinical validation of 11 biomarkers in humans for resuscitation-therapy in clinical studies (2) validation and CE-approval of the diagnostic device BioM-11 (3) validation and CE-approval of the CIRD 2.0-system for the resuscitation of patients (4) Clinical validation of the CIRD 2.0-system in-hospital and out-of hospital in 10 to 15 clinical centres in Europe to provide evidence for the new therapy called “controlled whole body reperfusion”. The overall project aims to show European leadership in this important field of emergency medicine and to hit the international market with a breakthrough-innovation in resuscitation medicine. At the end of the innovation project Technology Readiness Level 9 will be reached, meaning that the CIRD 2.0-system will be ready for full commercialization. The system will be the first device of its kind worldwide, which is designed primarily for the resuscitation of patients using extracorporeal circulation. The main economic goal of ResuSciTec is worldwide innovation- and market-leadership in the market segment of resuscitation devices. It is possible to reach this position because no other system on the market is able to fulfil the specific requirements for “controlled whole body reperfusion”.