Periodic Reporting for period 2 - FLOWMAKER (Saving patients from severe heart failure)
Berichtszeitraum: 2023-10-01 bis 2025-03-31
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.
The FLOWMAKER® project has successfully advanced its miniaturized pulsatile cardiac assist system from Technology Readiness Level (TRL) 5 to TRL 8 over the period from October 1, 2022, to Mar 31, 2025. Major achievements include two design iterations with relative manufacturing and verification loops, qualification of industrial processes (including clean rooms), the production of over 50 clinical-grade devices, the first-in-human implantation of the device, and regulatory preparation for a multi-center European feasibility/FIH trial. All deliverables and milestones scheduled up to Jan 8, 2025 (the date of the last intermediate report) were completed as documented in the three intermediate reports (Oct 6, 2023, Jul 4, 2024, and Jan 8, 2025). Activities in the final quarter included: completion of the FIH report; finalization of the improved device (including asymmetric ring components), with all V&V concluded and production documentation made manufacturing-ready; submission of the dossier to ANSM, receipt of formal approval; and sustained efforts in external communication at conferences and in the press, project governance, and IP portfolio management. This report, therefore, recapitulates the progress already reported up to Jan 8, 2025, and outlines the additional results achieved between Jan 9, 2025, and Mar 31, 2025 (the end of the project), demonstrating full alignment with the project objectives.
The FLOWMAKER® program delivered a first-in-class fully implantable pulsatile cardiac assist system at TRL 8, providing preliminary human evidence of safety and hemodynamic efficacy. Industrial scale-up has been secured through a certified 1200 m² facility which is strategically expanding to 3500 m² by 2026 and a qualified multi-supplier chain, de-risking future production. The expanded IP portfolio (26 families, 55 grants) and strong KOL endorsement position the technology for rapid clinical adoption and investment. Regulatory submissions in Slovenia and France shorten the path to a multi-center pilot trial and subsequent CE-mark approval, accelerating patient access and reinforcing Europe’s competitiveness in innovative medical devices. The FineHeart's FLOWMAKER® has the potential to stop HF disease degeneration while reducing procedure times and hospital stays, lowering complication rates, and dramatically improving patient quality of life (QoL). With its ability to trigger heart remodelling, unprecedented recovery data will give hope to hundreds of thousands of patients in Europe and worldwide.
Our Mission
• To restore the health of patients with advanced heart failure
Our Vision
• FineHeart's ambition is to become a global leader in the development and manufacture of innovative medical devices, driven by a commitment to manufacturing excellence and operational excellence within Europe. We have implemented a clear strategy to cultivate in-house expertise and capabilities to achieve the following:
• Building a World-Class Team: We are committed to hiring the best and brightest talent with extensive experience in our target markets and technologies.
• Strategic Manufacturing Infrastructure: We are investing in advanced manufacturing facilities to ensure uncompromised quality and high-volume production. Our clinical development will involve a complete design transfer, targeting an annual production capacity of thousands of units to support both EU CE Marking and US EFS trials. By September 2026, we will be operating from our state-of-the-art facilities, complete with cleanroom assembly and extensive laboratory testing capabilities to support future regulatory requirements and pivotal studies.
• Strategic Partnerships for Scalability: We are partnering with Lauak, a leader in precision machining, to ensure we can scale production rapidly to meet growing market demand and to facilitate expansion into new markets following European regulatory approval (targeted for 2027).
• This clear vision guides our ongoing development of FLOWMAKER® technology and informs our relentless dedication to improving the lives of patients.
Our Mission
• To restore the health of patients with advanced heart failure
Our Vision
• FineHeart's ambition is to become a global leader in the development and manufacture of innovative medical devices, driven by a commitment to manufacturing excellence and operational excellence within Europe. We have implemented a clear strategy to cultivate in-house expertise and capabilities to achieve the following:
• Building a World-Class Team: We are committed to hiring the best and brightest talent with extensive experience in our target markets and technologies.
• Strategic Manufacturing Infrastructure: We are investing in advanced manufacturing facilities to ensure uncompromised quality and high-volume production. Our clinical development will involve a complete design transfer, targeting an annual production capacity of thousands of units to support both EU CE Marking and US EFS trials. By September 2026, we will be operating from our state-of-the-art facilities, complete with cleanroom assembly and extensive laboratory testing capabilities to support future regulatory requirements and pivotal studies.
• Strategic Partnerships for Scalability: We are partnering with Lauak, a leader in precision machining, to ensure we can scale production rapidly to meet growing market demand and to facilitate expansion into new markets following European regulatory approval (targeted for 2027).
• This clear vision guides our ongoing development of FLOWMAKER® technology and informs our relentless dedication to improving the lives of patients.