Heart failure (HF) affects >64M patients worldwide and is one of the costliest medical conditions to manage. Arrhythmias are the most triggering conditions for HF and sudden cardiac death (SCD). CardiNor has exclusive right to the IPR of a new cardiac biomarker: Secretoneurin (SN), the only biomarker specifically linked to the heart’s electrical circuitry and myocyte calcium regulation, responsible of most triggered arrhythmias. With SHEF, we aim to bring to market a new in vitro diagnostic kit to measure SN blood concentration. Our primary target population are HF patients with risk of life-threatening arrhythmias that will be accurately risk stratified with the SN test, for an adequate monitoring/treatment. For every 25% of low-risk patients that are safely diverted from surgery due to regularly low SN level, ~505M€/year can be saved in the EU. This is the opportunity to approach the global cardiac monitoring and diagnosis market, with a breakthrough arrhythmia-linked biomarker.
CardiNor AS will lead the project, which will consist in conducting a large-scale multi-site clinical validation of our SN ELISA test with HF patients and its market launch and commercialization. The main barriers for CardiNor going forward are related with the acceptance by end-users and regulatory approval. The SHEF project will enable: 1) clinical validation and demonstration; 2) obtaining regulatory approval; 3) engaging with key opinion leaders and stakeholders.
There is rising potential for a fit-for-purpose SN test for immediate use in routine diagnostic, treatment selection and prognosis of high-risk patients, as supported by European Society of Cardiology guidelines. Thus, the EIC Accelerator program will unlock a critical funding step in our innovation roadmap, by ensuring that we swiftly achieve key milestones including to showcase the potential of our innovation and convince the medical community to widely adopt the SN test.