FACTA
Straight to the heart of biocompatibility
Key numbers
88 people
every hour
in 2023, will undergo a heart valve replacement surgery with implantation of a bioprosthesis.
1.4 million
patients
in 2030 will require a heart valve replacement surgery with bioprosthesis implantation.
800,000 Euro
every hour
spent in the world, due to complications related to the limited durability of marketed heart valve bioprostheses.
Technology
Facta® is the technology developed by BCI to improve the performance of all implantable bioprosthetic medical devices and animal-derived substrates used as support, construction and surgical repair materials.
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The alpha-Gal molecule
Facta® technology was developed for being applied to bioprosthetic tissues to improve their immunogenic tolerability. When a bioprosthesis is implanted, these molecules are recognized as foreign by the human body, which attempts to eliminate them, degrading the bioprosthesis itself. In particular, the alpha-Gal molecule is the most responsive in this respect. Inhibiting the alpha-Gal and all other epitopes, such as sialic acids, inhibits the post-implantation immune reaction and the subsequent inflammation. In a nutshell, the bioprosthesis is made totally biocompatible, which prolongs its longevity.
The key actions of the Facta® technology are the inhibition of the xenogeic molecules belonging to the animal tissue used to manufacture bioprostheses. Facta® also detoxifies from aldehydic residues, a chemical element used, and not currently substitutable, for the bioprostheses manufacture.
Principle
Biocompatibility Innovation nasce nel 2014 a Este, nel cuore di un territorio legato alla tradizione di ricerca e innovazione dell’università patavina.
BCI
BCI possiede un portfolio di 4 brevetti relativi alla tecnologia Facta®.
Altri brevetti sono in fase di stesura.
Polyphenols are the core of the Facta® technology
L’ideazione della tecnologia Facta® è iniziata nel 2015, con l’individuazione del suo core: una miscela di polifenoli opportunamente scelti e usati in condizioni specifiche per il trattamento dei tessuti bioprotesici. I polifenoli sono molecole di origine naturale prodotte dal regno vegetale. Si conoscono più di 5.000 tipi diversi di polifenoli, ma solo quando alcuni di essi possono agire in sinergia si attivano i benefici dimostrati da Facta®.
The mechanism of action
The Facta® technology acts chemically on bioprostheses, forming permanent and stable bonds. The FACTA® technology acts as a “bridge” between the tissue proteins and aldehydes, permanently stabilizing and proving the entire structure a better mechanical behavior.
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The role of the Facta® technology
The glutaraldehyde is an aldehyde currently used by the manufacturing industry: while it is currently irreplaceable – both for the sterilization of the tissue and for its ability to make it mechanically stronger – this substance is known to have toxic effects when the bioprosthesis is implanted in humans. Glutaraldehyde is also responsible for the attraction of calcium salts present in the blood: the consequence is the calcification of the bioprosthesis, one of the many ways in which the tissue that constitutes it degenerates.
The Facta® technology detoxifies from the toxic residues of glutaraldehyde.
Finally, marketed bioprostheses treated using the FACTA® method have been shown both in vitro and in vivo to be protected against thrombus formation and to be inhospitable to bacteria: thus preventing infection, especially in the peri-operative phase. Among the side effects, the action of the treatment acts on the stabilization of the animal tissue, preventing the formation of tears, lacerations and abrasions.
In-vivo biological effects
The Facta® action three-dimensionally protects the bioprosthetic tissue against post-implantation insults and degradation reactions.
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