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Work that lasted for months, days and nights, thanks to the intervention of excellent teams – cardiac and veterinary surgeons – from the Gemelli University Hospital in Rome. And the first results confirm the validity of the treatment developed by BCI (BioCompatibility Innovation), the innovative Paduan start-up that exploits the action of the natural active principles of derivation for to double the duration of cardiac substitutes of animal origin . " The treatment applied to valves is compatible with the physiology of the animals in which they were implanted – explain Alessandro Gandaglia and Filippo Naso, biologists and co-founding with BCI doctor and entrepreneur Ugo Stefanelli -. We can state that the valve remains competent and appropriate, will not alter the physiological parameters, and confirm the total absence of treatment toxicity and safety of the implant in humans. The experiment will continue for other months, but the results are totally comforting . "
To house the valves treated with the patented FACTA methodology, developed by BCI, are common pigs. the team conducting the experiments Professor Mbadimo Mbadetti Director of the Cardiovascular Center of the A. Gemelli University Polyclinic Foundation in Rome and Ordinary of Cardiac Surgery at the Catholic University of the Sacred The second part of the study involves experimentation on knockout pigs, genetically modified, with a physiological system even more similar to that of humans. Arriving in 2021 to implant valves treated, and therefore more resistant, on the man
Meanwhile, BCI, a startup that has already received 750 000 euros in funding, also obtained the certificate Label of Excellence of the Horizon 2020 Evaluation Commission of the European Union. An international recognition confirmed by the great interest that BCI has aroused around the world. In Italy, in Europe and finally Beijing on the occasion of the invitation to the World Convention on the Transfer of Technology organized by the European Chamber of Commerce in China . An open innovation platform for startups, businesses and institutions to accelerate its growth process and access Asian markets through collaborations with investors and businesses on the spot. AIRmaker, for example, a platform located in the Ljubljana Technology Park, connects European startups to two of Asia's most dynamic and developing ecosystems: Singapore and Hong Kong. The next appointment is already set: in September, the BCI team will travel to Bordeaux in France, for the 16th World Congress of the International Society of Applied Cardiovascular Biology (ISACB), where the researchers will present their own work to demonstrate how FACTA treatment is effective in preventing the onset of calcification, even when applied to valves not traditionally fixed with glutaraldehyde
The process developed by BCI starts from the inactivation of the alpha-Gal molecule, one that triggers undesirable reactions in current biological heart valve prostheses (bioprosthesis). The adverse reaction to the alpha-Gal antigen affects all carriers of the bioprosthesis: in 50% of cases, it induces calcifications that force valve replacement an average of 10 years after implantation. Calcification also develops more rapidly if the transplanted patient is young. Bioprostheses currently on the market are chemically treated in such a way as to create a shield between alpha-gal and the immune system without being able to effectively solve the problem . Calcification is then slowly but inexorably. Under 35, replacement is necessary after ten years from the first implant for 100% of patients; Over 35 years, in 50% of cases it is necessary to perform a new intervention after about ten / twelve years. If we consider that during a medium life, the maximum number of valve replacements that can be performed is 2 or 3, it is clear that this problem has direct effects on the quality of life of these patients. " The alpha-Gal antigen is a small molecule expressed in all mammals except man. The animal tissues used for the manufacture of current heart valve substitutes (mainly pigs and cattle), have this characteristic – explains Filippo Naso – This molecule is mainly responsible for the implementation immunological reactions leading to degeneration and dysfunction of the implanted valve bioprosthesis. The human body produces large amounts of antibodies directed against this molecule to eliminate it and thus eliminate the source that caused it, ie the animal tissue of which the valve is made ".
BCI has developed a method of treating valves – called FACTA – protected by an international patent whose results were presented to the scientific community by a publication in the journal "Tissue Engineering Part A" on May 10th. The peculiarity of this treatment lies in its ability to inactivate the alpha-Gal antigen and therefore to inhibit calcification processes by more than 85%. In laboratory tests, the treatment also demonstrated the ability to make the tissues more resistant from a mechanical point of view.
The consequences of the applications of this process are very important from both an economic and a health point of view. Prostheses of animal origin are indeed much used more mechanically than on that of deceased donors. " In 2016, 400,000 heart valve prostheses of animal origin were sold worldwide. The total cost of patient care was estimated at approximately $ 14 billion in 2016, due to new valve replacement procedures and those needed to damage previously implanted bioprostheses. The technology developed by BCI, aimed at extending the life of the bioprostheses themselves, as well as ensuring a significant reduction in the re-intervention rate, will lead to a significant savings in public health expenditure " concludes Alessandro Gandaglia .
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