Prediction of outcomes and Personalized treatment in heart failure patients with cardiac resynchronization therapy

Pacertool is an emerging Norwegian medtech company that discovered a breakthrough cardiac biomarker – Td - to improve Cardiac Resynchronization Therapy (CRT) in dyssynchronous heart failure (dysHF) patients. 64M people live with HF worldwide, of which 20% suffer from dysHF. The implantation of a CRT pacemaker is the most important treatment for dysHF but around 50% of patients do not improve with this treatment (25% even get worse), being instead subjected to unnecessary risky surgeries, costly follow-ups and worsened outcomes. Additionally, even when the right patient is selected, other limitations such as improper implantation of the CRT device may lead to poorer results. As a result, 1-2Bn€ are spent on ineffective CRT every year, whereas almost half of the dysHF patients, who could benefit from the treatment, do not receive CRT due to the lack of confidence of clinicians and healthcare systems on the approach. This is especially dramatic given the projected 46% increase in HF by 2030. Pacertool has developed an unique hardware and software system – PaCRTool – that provides electrophysiologists real-time insights into patient specific pathophysiology by measuring a specific biomarker through the evoked response from direct stimulation of the heart. PaCRTool will drastically improve CRT outcomes by i) accurately identifying patients who respond to CRT, ii) optimizing the pacemaker lead positions and iii) validating the implantation. Higher responders’ rates will increase the cost-benefit of CRT and its global adoption, whereas the accurate identification of patients who will not improve with treatment may lead those to life-saving alternative treatments. The EICA will allow Pacertool to perform large scale clinical trials, needed to obtain valuable clinical evidence for finalization of the product and certification (EU and US). Without this support, given that the solution is still TLR6, the remaining steps to market will be hard to complete in a timely manner.