Projects

Innovations for Heart and Vessels Sp. z o.o. has received a European Union grant from the Polish Agency for Enterprise Development for a project titled “Development of Production Technology and Prototypes of Biological Valve Implants for Percutaneous and Minimally Invasive Treatment of Valve Defects.” Grant agreement number: FENG.01.01-IP.02-1053/23.

The goal of the project is to create an appropriate research and development infrastructure, followed by the production and clinical testing of a new generation of biological TAVI (Transcatheter Aortic Valve Implantation) based on innovative production methods, utilizing advanced techniques for obtaining biological material, and employing original methods for shaping valve leaflets.

The R&D work will involve developing a fully reproducible method for processing biological material, as well as designing and formulating the process for forming and sewing, including computer studies of a previously created mathematical model of valve function and identified areas of increased stress. The research will also cover the development of the final version of the stent and an innovative delivery system.

A team of several highly qualified specialists in fields such as interventional cardiology, cardiac surgery, biotechnology, medical device quality, preclinical research, clinical research, medical statistics, informatics, and virtual modeling will be engaged in the R&D project.
An essential element of the project will be the preparation and testing of R&D infrastructure (pilot line) that meets the requirements of enhanced cleanliness for the production of valve prostheses. On this line, based on 3D models and laser cutting, a prototype series of valve prostheses will be produced for conducting First in Man (FIM) clinical trials, preceded by toxicity, mechanical and durability test and a preclinical study in a sheep animal model (in-vivo). The R&D infrastructure and equipment necessary for conducting R&D work will include, in particular, the following items:

• “Clean Room” facilities;
• laser with computer equipment;
• valve assembly devices, optical profilometer;
• laminar chambers, fume hoods, incubators, climatic chambers;
• valve system packaging device;
• other equipment necessary for the production and testing of valve implants.

The TAVI biological valve developed as part of the project will be the first medical device of this type produced in Poland. A key feature of the new valve will be its ability to be personalized. Its low profile and self-positioning system will facilitate valve implantation and allow for percutaneous aortic valve implantation procedures to be performed in centers without on-site cardiac surgery backup, increasing accessibility to these procedures and reducing hospital waiting lists.
The most important outcome of this project will be the introduction of a new biological aortic TAVI valve into the market.

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Project value: 55,983,590.00 PLN

European Funds contribution: 31,878,537.56 PLN

Our polymeric InFlow valve project has been granted a Seal of Excellence – an official document issued by the European Innovation Council as a recognition of the scientific excellence of our project. This allowed us to successfully apply for public funding for the polymeric valve project from the Polish National Center for Research and Development.

Innovations for Heart and Vessels Sp. z o.o. has received a European Union grant from the Polish National Centre for Research and Development for a project titled “Polymer Transcatheter Aortic Valve Implants with a Dedicated Delivery System.” Grant agreement number: FENG.02.09-IP.01-0008/23.

The project’s goal is to develop a prototype polymer TAVI (transcatheter aortic valve implantation) – a new aortic valve implant – and to confirm its key characteristics and functionalities in terms of strength and fatigue properties, as well as biocompatibility and non-toxicity.
The direct beneficiaries of the project results are patients with valve defects. The product will be available to all patients indicated for TAVI procedures and we hope that the new valve will enable the TAVI procedure to be safely performed in younger patients due to a long life span of the polymeric valve. The results of the project will have a positive impact on accessibility and can relieve patients from disease symptoms and extend their survival.

The planned R&D work includes: developing the polymer material and its production technology, producing the material and product for testing, advancing electrospinning technology for polymer fiber production for stents, and determining the optimal parameters for the electrolytic refinement process.
A team of highly qualified specialists in fields such as interventional cardiology, cardiac surgery, polymer materials, biomedical engineering, medical device certification, preclinical research, clinical research, informatics, and virtual modeling will be engaged in the R&D project.
The growing demand for minimally invasive methods for treating heart valve defects, especially in aging societies, creates an urgent need for more accessible and durable solutions. The TAVI procedure market is dynamically developing; it reached a value of approximately EUR 5.2 billion in 2021. Treatment costs remain high, limiting the availability of medical procedures. A polymer heart valve can significantly improve the quality of life for patients, offering a long-lasting and safe solution for those with aortic valve defects. With advanced technologies, TAVI procedures will become more accessible and efficient, reducing the risk of complications and treatment costs, with the potential for use in younger patients as well.

The most important target result of the project will be the introduction of a polymer transcatheter aortic valve along with its delivery system to the market.

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Project value: PLN 15,272,898.76

European Funds contribution: PLN 10,691,029.13

Innovations for Heart and Vessels Sp. z o.o. has received PLN 64,000.00 funding which enabled us to prepare full application documentation when applying for the EIC Accelerator grant from the European Innovations Council.