BioCoStent

Project partners

University of Thessaly / University of Ioannina

Biomedical Research Foundation of the Academy of Athens (BRFAA)

FEAC Engineering / Rontis AEBE

University of Thessaly

https://www.uth.gr/

The University of Thessaly, after the recent merge with the Technological Education Institute (TEI) of Thessaly, is one of the largest Educational Institutions in Greece. It is among the 5 best Greek HEIs and belongs to the 10 Greek institutions that have achieved the largest community funding to date by Horizon 2020.

Professor Anargyros Moulas of the University of Thessaly is the principal investigator and coordinator of the project.

The project is implemented at the General Department of Larissa, Laboratory of Chemistry and Biochemistry. The Laboratory specializes in the development of drug release systems for medical devices and the application of advanced analytical methods, mainly chromatographic and mass spectroscopic, for kinetic studies and chemical analysis of biological and other samples. The Laboratory’s technical and research interests also include fat-soluble vitamins with an emphasis on vitamins D and A (retinoic acid) and natural products, phytochemicals, and antioxidants. The molecular mechanisms and their action in vivo are studied with biochemistry and clinical chemistry methods and applications on nutrition and food are developed.

As part of the project, the Laboratory in collaboration with the company Rontis developed and registered with an international patent the use of retinoic acid in intravascular devices, while another patent for drug release systems has been filed by them. The Laboratory participates in WU1 in the development of the drug release system, in WU2 in the in vitro study of the effect of the stent components on vascular cells and in WU3 in the in vivo study with the analysis of drug levels by liquid chromatography and mass spectrometry HPLC/MS/ MS to study the kinetics of drug release from the delivery system under development. Finally, together with all the other partners, it participates in WU5 and the feasibility study.

 

University of Ioannina

https://www.uoi.gr/

At the University of Ioannina, research (basic and applied) as well as experimental development is carried out in all fields and subjects covered by the Institution’s Departments and Schools. Particular emphasis is placed on interdisciplinary programs of applied research and experimental development that are of interest to industry, economy and society, both nationally and regionally. The research is mainly financed by the Community Support Frameworks (A’, B’, C’ CSF, NSRF 2007-2013, NSRF 2014-2020) through its various Operational Programs, by the Territorial Cooperation Programs (INTERREG), by the European Commission (FP6, FP7, HORIZON 2020 etc.), as well as from the private sector. The University of Ioannina operates with a quality management system according to the ISO 9001 Standard: 2000 as well as with the Greek Standard of Administrative Performance, with the subject “Management of Research and Development Projects and other Related Programs and Activities”. The BioCoStent work will be undertaken by the Medical Technology and Intelligent Information Systems Unit (Medlab) laboratory and the Second Cardiology Clinic of the University of Ioannina.

Medical Technology & Intelligent Information Systems Unit – MedLab. MedLab is an important research core active in the field of Biomedical technology and the development of intelligent information systems. The unit has as a research object the understanding of the theoretical background of Biomedical Technology, as well as the understanding of the basic operating principles of biological systems and biomaterials, the development of efficient technologies, based on engineering, to cover a wide range of needs. These needs concern the fields of biological systems modeling, biomechanics, medical technology, automated diagnosis, biomaterials, bioinformatics, patient monitoring systems – using wearable systems, sensors and biosensors,

 

The research activity focuses on the following:

1. Modeling of physical systems, biomechanics and medical technology: Computational models of biological tissues and systems including endovascular prostheses (stents), hard tissues (bones) to study ultrasound propagation for fracture healing and soft tissues (arteries) to study plaque development, glucose metabolic models, etc.

2. Automated diagnosis: Techniques for the intelligent processing and analysis of medical image and medical and other signals for the purpose of identifying problems related to diseases or symptoms of diseases. Decision support systems for automatic diagnosis among other cardiovascular diseases, breast cancer, etc.

3. Biomaterials: Study of mechanical properties in intravascular stents, bone stents, implantable materials and biomagnetic materials. Applications of biomaterials in cardiology, orthopedics, magnetic drug targeting.

4. Bioinformatics: Analysis of biological sequences (DNA, proteins, etc.). Processing large volumes of medical, genetic and other related data.

5. Patient Monitoring Systems – Wearable systems.

 

The above research activities include:

1. The provision of undergraduate and postgraduate courses in subjects related to the activity of the laboratory, etc.

2. The preparation of diploma/postgraduate/doctoral theses.

3. The publications in reputable scientific journals, conference proceedings, books and scientific publications of the research results.

4. The dissemination of research results at national and international level and the participation in seminars, conferences and workshops.

5. Scientific cooperation of any kind with Research Centers and Academic, Educational and Research Institutions at home and abroad, private sector companies, as well as with official international or Greek organizations and state agencies, public benefit institutions, non-profit organizations and institutions for teachers or research purposes.

6. The organization of Conferences, Symposia, Seminars, Workshops, Lectures and other scientific events.

7. Participation in research programs (national, European, international).

8. The operation and maintenance of research laboratory infrastructure for the characterization of biomaterials, biological tissues, experiments on animals at the experimental animal station, etc.

9. The provision of services to third parties and the preparation of studies and expert opinions related to the objects of the unit’s activity.

 

The Medical School of the University of Ioannina is one of the seven Medical Schools in Greece. Founded in 1977, its evolution is impressive considering the achievements and reputation it has acquired in such a short period of time. The work on the BioCoStent project will be done by the Second Cardiology Clinic of the University of Ioannina. The department has a very active role in the education of undergraduate medical students, in cardiology specialization and in the continuing medical education of cardiologists in the region of Northwest Greece. It also plays a key role in increasing public awareness in matters related to cardiovascular diseases and the wider communication of prevention and treatment methods in the local community. .

The Department participates in large international randomized controlled trials and registries. The Second Cardiology Clinic collaborates in research with the following Scientific Societies and University Units such as the Hellenic Cardiology Society, the Hellenic Society of Pulmonary Hypertension, Dallas VA Medical Center (USA), Institute for Medical Science and Engineering (USA), Dept of Interventional Cardiology – Erasmus Univ. Medical Center (Netherlands), Massachusetts Institute of Technology (USA), Dept. of Interventional Cardiology, Heart Inst. (Univ. of Sao Paolo, Brazil).

The UOI will be responsible for WU4 which concerns the development of the in silico platform and more specifically the modeling of the stent deployment, the modeling of the drug release as well as the Modeling of the degradation of the coating (coating), as well as for WU5 which concerns the preparation of the feasibility study, which will include data on the functional and economic-technical characteristics of the BioCoStent fully defining the parameters that will justify the routing of further investment by the partners of the partnership. He will also have participated in WU3 related to the in vivo study of DES characteristics and WU4 related to the development of the computational model.

Medical Biological Research Foundation of the Academy of Athens (BRFAA)

http://www.bioacademy.gr/home

The Research Foundation of the Academy of Athens (BRFAA) is one of the largest independent Research Institutions in Greece with three Research Centers, 400 research staff (including postdoctoral researchers, PhD students and technicians) and 44 Researchers and faculty members coming from leading organizations from Europe and the USA. BRFAA supports basic, translational and clinical research through main research directions in cardiovascular and respiratory diseases, neurodegenerative and autoimmune diseases, cancer, immunology, pharmacology and molecular and cellular biology. Since its operation in 2003, BRFAA has participated in 70 FP6, FP7 or Horizon 2020 competitive programs of the European Commission, in several of which as coordinator, including Marie Curie (Initial Training Networks, Industry-Academia Partnership Programs etc.). The Immunobiology Laboratory of the Center for Clinical, Experimental Surgery and Translational Research has a cell culture room, a molecular biology room, a microscopy room with fluorescence microscopes and an automated laser capture microdissection system (automated PALM laser capture microdissection system), two flow cytometry and cell isolation rooms (equipped with BD and Beckman Coulter flow cytometers and cell sorters) and enough laboratory space for experimentation.

The Immunobiology laboratory focuses on the study of immune mechanisms involved in cardiovascular diseases and in particular the development of unstable atheromatous plaques and the induction of symptoms. It uses unique short-term culture systems of human atherosclerotic plaques as well as experimental animal models. It also applies holistic analyzes and omics technologies to discover processes and biomarkers that predict disease progression and may have prognostic and therapeutic value. Through its participation in European Research Networks, the Immunobiology laboratory has access to omics data of large populations as well as international collaborations for the study of cardiovascular diseases (coronary artery disease and carotid stenosis).

 

The Animal Models and Experimental Surgeries Unit covers a total area of 1,600 sq.m. and has the ability to house a total of 25,000 mice, 1,000 rats, 40 rabbits and 10 pigs. The Unit meets all the relevant specifications of the European and National Legislation on the protection of animals used for experimental and other scientific purposes (Presidential Decree 56/2013) and is approved by the competent Directorate of Veterinary Medicine of the Prefecture of Athens. In particular, the small rodents are housed in special units of individually ventilated cages (Individual Ventilated Cages) that ensure the best possible ventilation per cage, with absolutely clean air. In the Animal Standards Unit, a complete program of veterinary care of animals is applied, which includes a program of preventive veterinary medicine, a program of veterinary vigilance, as well as a veterinary care program for animals used in experiments (anesthesia, analgesia, euthanasia, endpoint identification). The Unit is also supported by the Experimental Surgeries in which it is possible to carry out aseptic surgical or other research procedures on various species of animal models from mice to pigs weighing 80 kg. The Experimental Surgeries, with a total area of 1,100 m2, consist of four operating rooms, two Intensive Care Units, sterilization areas, sterile material warehouse, consumable material warehouse and auxiliary spaces for the medical and nursing staff. There is also a laparoscopic tower, as well as a C-ARM fluoroscopic machine for performing cardiac catheterizations and angiograms. A surgical microscope is available to perform microsurgery. With appropriate anesthetic devices and respirators, anesthesia can be given to animal models weighing from 10 gr to 80 kg. The special technical equipment of the operating rooms includes: an ultrasound flowmeter to measure the blood supply to the various organs, a device with which, after the placement of piezoelectric crystals, the longitudinal and transverse changes in the dimensions of the aorta during the cardiac cycle are monitored, Millar catheters for the high-fidelity measurement of intraluminal pressures as well as catheters for the study of heart failure in mice and rats. The center also has a telemetric monitoring system for various physiological parameters (heart rate, mobility, blood pressure and heart rate variability) for small rodents. The two Intensive Care Units are equipped with special cages for the post-operative monitoring of animal models in which the environmental conditions inside the cage, such as temperature, humidity and oxygen content, are regulated. There is a possibility of continuous monitoring of the animal’s vital functions and their mechanical support. The Experimental Surgeries are ISO 9001:2008 certified and operate in accordance with GLP guidelines. There is a possibility of continuous monitoring of the animal’s vital functions and their mechanical support. The Experimental Surgeries are ISO 9001:2008 certified and operate in accordance with GLP guidelines. There is a possibility of continuous monitoring of the animal’s vital functions and their mechanical support. The Experimental Surgeries are ISO 9001:2008 certified and operate in accordance with GLP guidelines.

The BRFAA will be responsible for WU3 concerning the in vivo study of DES characteristics and will participate in WU 2 related to the in vitro study of the characteristics of the system under development (stent, polymer, drug) and WU5 which includes strategic planning and the promotion of project results.

FEAC Engineering

https://feacomp.com/

FEAC is at the forefront of technological innovation and is active in the design and development of innovative products, through electromechanical simulation with the finite and boundary element method. Using sound scientific knowledge and taking into account all aspects of Physics (mechanics of materials, heat transfer, fluid mechanics, electromagnetism, etc.), the company designs innovative products in a simulated environment, checking their performance, predicting their behavior , minimizing manufacturing errors and risk and reducing development costs. Consequently, the company works in support of businesses and organizations that wish to manufacture or develop a new innovative product,

FEAC’s high level and internationally recognized services include CAD design, advanced finite element (FEM) and boundary element (BEM) analyses, design optimization techniques and structural condition monitoring (SHM) of prototype models using computer aided engineering (CAE) tools. The company cooperates with international private companies, research centers and universities, helping them to exploit the benefits of electromechanical simulation and numerical models in order to obtain a complete study of the product to be manufactured (structural analysis, prediction of behavior in real conditions, efficiency, etc.). a.).

In addition, FEAC, in collaboration with the Polytechnic University of Patras (Department of Mechanical Engineering & Aeronautical Engineering) and the ATEI of Patras (Department of Mechanical Engineering), is developing its own computational tool based on the boundary element method (BEM), which provides highly accurate results in problems of mechanics that have to do with infinite and semi-infinite space, such as sound propagation (undersea noise, noise pollution), soil mechanics (foundations, seismic waves, oscillations), radiation transmission and wave scattering (e.g. radar, antennas) etc. a.

 

The company is a member of the following institutions and organizations:

  • NAFEMS (National Agency for Finite Element Methods and Standards)
  • HEMEXPO (Hellenic Marine Equipment Manufacturers and Exporters)
  • Si-Cluster
  • EVIDITE (Association of Hellenic Industries of Space Technology & Applications)

FEAC has participated / participates in entrepreneurship forums (e.g. Greece-Germany Business Forum, Business Mission to Israel accompanied by the President of the Hellenic Republic, Space Industry Days in Toulouse (FR) & ETEC (NL)), exhibitions (POSIDONIA 2016, SMM 2016, Patras IQ, MT 25 – 25th International Conference on Magnet Technology in Amsterdam (2017), etc), constantly expanding its circle of partners and proceeding to partnerships and business agreements.

 

The company has been distinguished and awarded both internationally and nationally:

A) The company has been awarded the 1st prize in the WORLD simulation competition ANSYS HALL OF FAME COMPETITION. The high-level services he provided to the International Research Center CERN for the study, development & design of the most powerful superconducting magnet ever built and currently operating at the LHC (Large Hadron Collider), led to the international recognition of the investment carrier.

B) The company has been distinguished and awarded as one of the ten best companies in the field of INNOVATION in the competition “Greece Innovates”, organized by BSE in collaboration with Eurobank.

Articles about the company’s achievements have been featured in internationally renowned scientific and technological magazines such as ANSYS Advantage, CERN Courier and NASA’s Techbrief, while references to the company have also been made in the domestic and international press, recognizing the company’s high value-added services. Examples: www.mitefgreece.org, www.kathimerini.gr, www.sev.org.gr, www.entre.gr, www.cerncourier.com, www.gutenberg.us .

The company has submitted proposals to recent research programs such as MANUNET, INCOMERA, FORTISSIMO and to the “Materials-Microelectrics” priority axis of its research and development strategy for smart specialization (RIS3), creating the necessary collaborative schemes. These are Research and Innovation projects for Small and Medium Enterprises (SMEs) in the context of the new programming period 2014-2020, while it also focuses on actions to create cooperative schemes and synergies with public and private bodies (technological companies, research centers, university institutions as well as state agencies), for writing and submitting proposals in research programs under H2020 and in thematic sections such as those of Space, the transmission and effect of underwater sound, Clean Sky and Smartcities. .

FEAC will participate in WU4 which is related to the development of the in silico platform and concerns the Modeling of stent deployment, the modeling of the drug release as well as the Modeling of the degradation of the coating, and even with WU5 which includes the strategic planning and promoting the results of the project.

Rontis Hellas A.E.B.E.

https://rontis.gr/

Rontis was founded in 1986. In its early stages, the company worked closely with internationally recognized medical device manufacturers in distributing their products and market their technologies in markets that lacked the appropriate know-how, efficient warehousing and distribution. In the years that followed, Rontis decided to expand its activity from distribution to in-house production of medical devices. Rontis has two state-of-the-art factories in research and development, production and packaging of interventional cardiology and radiology devices, Nephrology, Urology, Anesthesiology consumables as well as fluid infusion products.

The following principles have been identified as the core pillars of Rontis, applied from the initial concept, research and development to the production process.

  • Inventing and designing quality products that incorporate the latest technology
  • The continuous improvement of the internal quality control system, in order to ensure the excellent safety and performance of the product
  • The immediate response to the expectations of the market and our partners
  • Ensuring technical and scientific support from experts in the field of Medical Technology products.

RONTIS is responsible for WU1 regarding the development of Drug Eluting Stent (DES) technology using a patented drug. He will also participate in WU3 which is related to in vivo study of DES characteristics. A metal stent suitable for drug delivery use will be developed as well as a delivery system (endovascular balloon catheter) on which the stent will be placed. These systems will be based on existing RONTIS systems which where necessary will be redesigned or modified appropriately to meet the requirements of the new product and drug release. It will be developed in collaboration with the TEITHES retinoic acid delivery system, a drug that is internationally patented by the company for use in intravascular systems. The company’s facilities will manufacture prototype drug-coated stents, they will be placed on the endovascular catheters that will be developed for this purpose and these systems will undergo a series of tests to check their suitability and functionality. In particular, there will be tests of mechanical properties and strength, drug release tests, sterilization tests, development and testing of suitable packages. The company will develop manufacturing methods and prototype the complete DES systems (balloon catheter, stent, drug-eluting stent) and assemble, package and sterilize the systems. Depending on the results during the study, variations will be made or the design of the products will be modified for optimal performance. RONTIS will be responsible for WU6 regarding participation in exhibitions. .