Pacing with Digital Twins of Brainstem Neuronal Circuits as an Effective Therapy for Chronic Cardiac Disease

Small neural networks known as central pattern generators (CPG) are now established as an effective therapy for unmet chronic cardiorespiratory disease such as heart failure. This approach restores the natural heart rate variability driven by neuronal sympathic/parasympathic tone and the adaption and synchronization of heart chamber timings to physiological feedback that is lost in disease or with age. Our technological breakthroughs consist of a 3-lead neuronal pacemaker emulating the brainstem circuits generating vagal tone and a nonlinear programming method (RPDA) training these circuits to restore the correct pacing adaption to changes in breathing, arterial pO2, and blood pressure.
This EIC transition project will translate our 3-lead adaptive pacing (PM) and cardiac biventricular resynchronization (CRT) technology from its successful proof-of-concept in acute trials and chronic small animal models of heart failure (TRL4) to a miniaturized solution which is compliant with CE mark certification and EMA requirements for Phase 1 human trials (TRL6). In the process, the technology will be matured, integrated and its safety improved under strict quality control. Large animal trials will be conducted over a period of 3 months follow-up with our PM-CRT to demonstrate reversal of adverse cardiac remodelling by new top-on-care treatment for heart failure. Animal trials will be extended to acute and chronic arrhythmias, caused by atrial fibrillation, to demonstrate new therapeutic option for diverse cardiac arrhythmias, validate medical hypotheses and broaden impact.
Project outcomes will be incorporated in a subsidiary of Ceryx Medical, a spin-off of UBAH. Investment readiness will be achieved through the delivery of a business plan incorporating market feedback, mapping the reimbursement landscape by healthcare providers, delivery of an IP strategy, quality control leading to a completed GSPR checklist, entrepreneurship, dissemination, and human trial plans.