WORK PERFORMED AND MAIN ACHIEVEMENTS:
Significant progress has been achieved in hydrogel optimisation, resulting in a thermoresponsive, homogeneous, and injectable material with controlled gelation, defined thermal transitions, high swelling capacity, and stable viscoelastic properties. Regulatory classification activities confirmed the hydrogel as a Class III medical device (MHRA), and preparations for ISO 10993–compliant biological evaluation are well advanced, with NAMSA Ltd. selected as the GLP-compliant provider. This staged evaluation includes a Biological Evaluation Plan, chemical characterisation, and biological testing to support progression toward first-in-human studies.
In parallel, the project developed a specialised endocardial catheter system capable of navigating the left ventricle, performing controlled intramyocardial injections, and integrating cooling and solution-mixing functionalities. Iterative prototype testing, informed by cadaver studies and ex vivo assessments, demonstrated reliable delivery performance, anatomical feasibility, and user operability, supporting readiness for subsequent validation activities.
Preclinical validation progressed according to plan, with a clinically relevant large-animal myocardial infarction model established to evaluate post-infarction cardiac remodelling and functional recovery. Refinements in MI induction protocols reduced procedural mortality and enabled long-term assessment. Completion of sham, MI, and PBS control groups confirmed reproducible infarction outcomes, establishing a robust platform for evaluating ELR hydrogel treatment, which is currently underway.
Concurrent efforts ensured scalable and quality-controlled hydrogel production. Lab-scale optimisation and GMP-aligned manufacturing workflows were established, and intermediate- and GMP-grade batches are being prepared to support preclinical studies and ISO evaluation.
The project also advanced regulatory, intellectual property, and commercialisation activities, aligning mechanisms of action, device classification, and preclinical evidence with clinical translation requirements. Strategic engagement with regulatory authorities supported clinical trial planning and future reimbursement considerations.
Success to date enabled the consortium to apply for the HORIZON-HLTH-2025-03-IND-03 call under Horizon Europe Cluster 1: Health, aiming to support multinational clinical studies and accelerate regulatory approval.
