Periodic Reporting for period 1 - BloodTurbine (Fully implantable patient-specific Artificial Hearts without External Power)
Période du rapport: 2021-11-01 au 2023-10-31
Patient population with end-stage heart failure in the EU grows by 5M annually. Due to donor shortage, only a handful of patients ever receive cardiac transplantation. Unfortunately, this results in 250K deaths every year. Long-term mechanical circulatory support (MCS) is a solution, but external power needs result in driveline infections and bulky systems limiting patient mobility. An innovative blood turbine device emerged from the parent ERC that can overcome these limitations. In this project we demonstrated that this novel turbine can drive MCS by transferring the available cardiovascular energy to the diseased site without the need of external power. Project team completed initial blood damage experiments and based on the feedback from these tests developed new versions of the prototype. Elimination of the bulky power systems and control units allowed three-dimensional printing of this artificial heart from biocompatible resins. This resulted a new “customized” VAD concept that can be precisely tailored for each individual patient needs. A patient-specific optimization and assist device protocol is also developed where 3D printed customized devices can be produced starting with the patient data. The proposed passive concept brought to TRL 3-4 level will provided further evidence on its potential to realize the long-sought use of ventricle assist devices (VAD) as a destination therapy. PoC project enabled the translation of this disruptive device to the bedside, by completing device optimization, comparative analysis and key preclinical experiments in accordance with the new MDR regulatory framework. Business development and IPR activities are also completed making the project team ready for the next phase in commertialization. We also explored its use with implanted blood oxygenators and established key partnership to apply the idea to larger adult cardiovascular disease markets, eg. right-heart failure. IPR also positioned to addressed these bigger markets. The low product cost (€1K vs. €120K) will allow access to a major untapped global market reaching 18 million people annually, as many developing countries have no access to expensive MCS systems. During the project timeline, business opportunities are validated, and major commercialization tasks are completed. In addition to the adults with right-heart failure, the developed device will improve the post-operative quality life of children with heart defects that require staged cardiovascular surgeries. Socioeconomic impacts span both the patients and their families.