Periodic Reporting for period 1 - FLOWMAKER (Saving patients from severe heart failure)
Reporting period: 2022-10-01 to 2023-09-30
The ICOMS FlowMaker® is the first intracardiac assist device that overcomes all shortcomings of current and under development devices
and restores patient's quality of life. Its design perfectly fits all the needs of patients suffering from severe heart failure. Implanted inside
the left ventricle and synchronized with natural heartbeat, it assists the heart to push blood in a physiological way. The very low electrical
consumption allows for wireless functioning. With no driveline crossing the skin, the risk of infection is suppressed. Without bypass to
aorta and thanks to its pulsatile mode, the risk of bleeding is very low. The ICOMS FlowMaker® addresses the market of severe heart
failure, where 95% of patients are left without any solution. The aim of the project is to conduct the clinical trials to enter the EU market
in 2026, then the US market, allowing to finally achieve EU sovereignty in severe heart failure treatment.
and restores patient's quality of life. Its design perfectly fits all the needs of patients suffering from severe heart failure. Implanted inside
the left ventricle and synchronized with natural heartbeat, it assists the heart to push blood in a physiological way. The very low electrical
consumption allows for wireless functioning. With no driveline crossing the skin, the risk of infection is suppressed. Without bypass to
aorta and thanks to its pulsatile mode, the risk of bleeding is very low. The ICOMS FlowMaker® addresses the market of severe heart
failure, where 95% of patients are left without any solution. The aim of the project is to conduct the clinical trials to enter the EU market
in 2026, then the US market, allowing to finally achieve EU sovereignty in severe heart failure treatment.
During the period, the project has made huge progresses:
Work Package 1, which includes 2 major phases of our design process (phase 3: Pre-industrialisation, process validation & manufacturing & Phase 4: Verification & Validation) is very close to its end. In October 2022 we were at the very beginning of these 2 phases with only prototypes of our products.
The FineHeart team has developped & documented through process maps each single process (packaging, labeling, sterilization, cleaning, manufacturing, assembly & so on). In addition, every inspection steps have been defined and documented. This represents sereral hundreds of internal procedures, instructions which have been created. The manufacturing operators have been trained to these processes and each manufacturing batch has its own traceability. More than 40 ICOMS Flowmaker have been produced during the period.
In terms of V&V, most of the required tests have been performed in order to fulfill the regulatory requirements. More than 15 animal trials have been conducted, some short term trials, other, long term trials have reached 60 days. A full range of in vitro tests have also been completed and are detailed in the deliverable call "ICOMS V&V summary". This report includes: hemolysis tests, electrical safety tests, reliability, biocomp, usability, and so on.
All of these successull achievments allowed us to receive approval from the IKEM hospital Ethic comitee mid August (in Prague) followed by the SUKL (Tcheque Republic health authority) to start our First In Human Clinical trial (which is included in Work Package 2).
Obviously work packages 4 and 5 (project management, communication, dissemination, IP & marketing) have moved at the adequat speed to support the project plan and reach our milestones. As examples, we have presented our solution at several international meetings : EACTS (Mechanical Circulatory Support Summmit the 16th of November 2022), EUMS congress in Paris on September 5th 2023, ISHLT in Denver 19-22 April 2023. In addition, several patents have been filed and published such as: WO2017/032510 "Pompe de flux sanguin pour assistance ventriculaire" published in Canada, then US-2022-0152375-A1 "Pivot de sortie pour pompe cardiaque à couplage magnétique", as well as CN114025828A "Pompe cardiaque à couplage magnétique et à flux inverse" and US-2022-0143384-A1 "Pompe cardiaque à couplage magnétique et à flux inverse".
The team is currenlty finalizing the training of the clinical team (IKEM hospital in Prague) which is planned to happen early November. The production to support the first patients is planned to end at the same time. To conclude, our plan is to do the First In Human surgery at the end of November 2023.
Work Package 1, which includes 2 major phases of our design process (phase 3: Pre-industrialisation, process validation & manufacturing & Phase 4: Verification & Validation) is very close to its end. In October 2022 we were at the very beginning of these 2 phases with only prototypes of our products.
The FineHeart team has developped & documented through process maps each single process (packaging, labeling, sterilization, cleaning, manufacturing, assembly & so on). In addition, every inspection steps have been defined and documented. This represents sereral hundreds of internal procedures, instructions which have been created. The manufacturing operators have been trained to these processes and each manufacturing batch has its own traceability. More than 40 ICOMS Flowmaker have been produced during the period.
In terms of V&V, most of the required tests have been performed in order to fulfill the regulatory requirements. More than 15 animal trials have been conducted, some short term trials, other, long term trials have reached 60 days. A full range of in vitro tests have also been completed and are detailed in the deliverable call "ICOMS V&V summary". This report includes: hemolysis tests, electrical safety tests, reliability, biocomp, usability, and so on.
All of these successull achievments allowed us to receive approval from the IKEM hospital Ethic comitee mid August (in Prague) followed by the SUKL (Tcheque Republic health authority) to start our First In Human Clinical trial (which is included in Work Package 2).
Obviously work packages 4 and 5 (project management, communication, dissemination, IP & marketing) have moved at the adequat speed to support the project plan and reach our milestones. As examples, we have presented our solution at several international meetings : EACTS (Mechanical Circulatory Support Summmit the 16th of November 2022), EUMS congress in Paris on September 5th 2023, ISHLT in Denver 19-22 April 2023. In addition, several patents have been filed and published such as: WO2017/032510 "Pompe de flux sanguin pour assistance ventriculaire" published in Canada, then US-2022-0152375-A1 "Pivot de sortie pour pompe cardiaque à couplage magnétique", as well as CN114025828A "Pompe cardiaque à couplage magnétique et à flux inverse" and US-2022-0143384-A1 "Pompe cardiaque à couplage magnétique et à flux inverse".
The team is currenlty finalizing the training of the clinical team (IKEM hospital in Prague) which is planned to happen early November. The production to support the first patients is planned to end at the same time. To conclude, our plan is to do the First In Human surgery at the end of November 2023.
Purpose: To demonstrate on a chronic heart failure sheep model the midterm hemodynamic efficacy and high degree of myocardial recovery induced by our ICOMS Flommaker.
Methods: Six adult sheep with a chronic heart failure induced by multiple sequential coronary microembolizations have been implanted with our pump and followed over 1 to 2 months through a left mini-thoracotomy was performed on a beating heart. It is a world first !
Results: Four sheep had a 2-month follow-up and 2 sheep were followed over 1 month. The surgical procedure duration was 82+/-15 min. The mean power consumption was 1.0+/-0.2 W. The internal battery autonomy
was 4+/-2 hours. Left ventricular ejection fraction (LVEF) improved from 26+/-4% to 57+/-5% in less than 15 days post-implant. The device was able to identify premature ventricular complexes and accordingly avoid non-physiological synchronization; atrial fibrillation was identified and systolic synchronization was efficiently maintained by use of a dedicated software. No pump thrombosis neither intra-ventricular damage were observed after animals sacrifice. A full device removal was performed in 2 animals on a beating heart procedure by use of a specific fixation system;
the animals were kept alive for 2 months and LVEF returned to the baseline altered values; then, the device was re-implanted and LVEF was back to normal again (55+/-4%) after 15-20 days.
Potential impacts : The FineHeart's Flowmaker has the potential to stop HF disease degeneration ; by its abilty to trigger Heart remodelling, unpreecedent recovery data will give Hope to Hundred Thousands of patient in Europe
Methods: Six adult sheep with a chronic heart failure induced by multiple sequential coronary microembolizations have been implanted with our pump and followed over 1 to 2 months through a left mini-thoracotomy was performed on a beating heart. It is a world first !
Results: Four sheep had a 2-month follow-up and 2 sheep were followed over 1 month. The surgical procedure duration was 82+/-15 min. The mean power consumption was 1.0+/-0.2 W. The internal battery autonomy
was 4+/-2 hours. Left ventricular ejection fraction (LVEF) improved from 26+/-4% to 57+/-5% in less than 15 days post-implant. The device was able to identify premature ventricular complexes and accordingly avoid non-physiological synchronization; atrial fibrillation was identified and systolic synchronization was efficiently maintained by use of a dedicated software. No pump thrombosis neither intra-ventricular damage were observed after animals sacrifice. A full device removal was performed in 2 animals on a beating heart procedure by use of a specific fixation system;
the animals were kept alive for 2 months and LVEF returned to the baseline altered values; then, the device was re-implanted and LVEF was back to normal again (55+/-4%) after 15-20 days.
Potential impacts : The FineHeart's Flowmaker has the potential to stop HF disease degeneration ; by its abilty to trigger Heart remodelling, unpreecedent recovery data will give Hope to Hundred Thousands of patient in Europe