TU/e is a leading international university worldwide, specializing in engineering science and technology, contributing to progress in technical sciences through excellent teaching and research. With over 7000 students, 2.300 staff members and 700 PhDs, TU/e is one of the first universities in Europe with a complete undergraduate and graduate program in Biomedical Engineering.
The Soft Tissue Engineering & Mechanobiology group of professor Carlijn Bouten holds a leading position in the field of heart valve research. Research themes include mechanobiology of heart valves, computational modelling of heart valves mechanics and remodeling, cell and tissue homeostasis, molecular signalling, micro-tissue platforms for high-throughput analysis, molecular imaging of tissue differentiation, scaffold design and manufacturing and molecular imaging of tissue differentiation.
Prof. Carlijn Bouten coordinates the ImaValve consortium. She aims to successfully disseminate and implement the results of the ImaValve project, both at the scientific level, and organizational level, by developing project activities (e.g. seminars) , coordinating activities and relations between partners, and managing communication and reporting. TU/e will also lead some of the work packages, i.e. Initiation and Early Tissue Formation (WP4) and Cell and Tissue homeostasis (WP5).
SupraPolix is an SME, commercializing innovative polymeric materials for applications ranging from adhesives and specialty coatings, to biomedical materials and cosmetics. SupraB™-materials deliver unique processing and rheological benefits together with tunable material performance. Key to all this is an innovative platform of supramolecular (UPy-) polymers, which is based on quadruple hydrogen bonding technology.
SupraPolix participated in several national public-private projects related to tissue engineering, i.e. the BMM-iValve project for tissue engineered heart valves and blood vessels; the BMM-BioKid for living membranes of bioartificial kidney devices; and the project on cardiovascular diseases in collaboration with the Netherlands Institute for Regenerative Medicine (NIRM).
Within the ImaValve project, SupraPolix will lead the work package on scaffold materials (WP1), focusing on the development of new bio-active and bioresorbable UPy-polymers for cardio-vascular implants.
Xeltis is a European medical device headquartered in Zurich, Switzerland. R&D and manufacturing facilities are located in Eindhoven. Using technology based on Nobel prize winning supramolecular chemistry, Xeltis develops implantable replacements intended to spontaneously grow and remodel into functional and healthy heart valves and vessels in vivo. Xeltis’ products are fully bioabsorbable synthetic grafts designed to harness the body’s natural healing response from the inside
Xeltis’ initial focus is the treatment of children with complex congenital heart diseases. Two clinical feasibility studies were recently performed, involving patients born with only one ventricle, who must undergo complex surgical procedures to ensure the proper circulation of oxygenated blood.
Within the ImaValve project, Xeltis will work for WP7, leading the implementation of the dissemination and exploitation plans. In addition, Xeltis will be involved in WP1, focusing on the biocompatibility of the hybrid scaffold and optimizing the polymer processing and electrospinning.
With its 26,000 enrolled students, the University of Zurich is the largest university in Switzerland. Numerous distinctions highlight the University’s international renown in the fields – among others - of medicine, immunology and structural biology.
The Medical faculty has a long tradition in translational research, with particular attention to the fields of tissue engineering, cell based therapies and disease modelling. A particular expertise established within the Swiss Center for Regenerative Medicine (SCRM) group is centered around pre-clinical experiments with tissue engineered heart valves and blood vessels in large animal models (in particular sheep model).
For the ImaValve project, UZH will lead the work package on preclinical experiments (WP5), performing trials according to Good Laboratory Practice (GLP) standards and ensuring regulatory compliance for first-in-man trials.
Medicut is an independent, EN ISO 13485/9001-certified SME founded in Germany in March 2007. With 24 full-time employees and over 25 years of experience, Medicut can guarantee superlative expertise in manufacturing of miniaturized medical products, prototyping, product approval and series production. Working with a wide panel of different materials, i.e. nitinol, stainless steel, tantalum and plastics, Medicut can successfully fabricate both individual components and complex assemblies for innovative products.
Medicut’s team has ample experience in heart valve stents and application system, being particularly specialized in the manufacturing aortic stents made from shape memory metal Nitinol and the adjacent delivery system.
Medicut will contribute to the work package 2 (WP2), leading the stent manufacturing, the process and the assembly of the heart valve delivery system.
Appletree AG is a specialized CSO (Contract Service Organization) offering services in clinical research and regulatory affairs. The headquarters are located in Switzerland, with local offices in twelve European countries. Appletree’s team count 50 employees, highly qualified in establishing partnerships with industrial companies, academia and investors.
Impressive track record includes regulatory consulting activities with a global scope for various indications and technologies, including tissue engineering. Moreover, Appletree has been recently involved in the project management and as a regulatory advisor in a project for autologous tissue-engineered vascular graft.
Appletree’s core activities in the ImaValve project will be on regulatory affairs matters (WP6), giving guidance in advice meetings with EMA and providing solutions for the medical/marketing authorisation of the final product.