Key numbers

 

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.

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 alpha-Gal molecule

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

 

Polyphenols are the core of the Facta® technology

 

The conception of the Facta® technology began in 2015, with the identification of its core: a mixture of appropriately polyphenols chosen and used under specific conditions for treating bioprosthetic tissues. Polyphenols are naturally occurring molecules produced by the plant kingdom. More than 5,000 different types of polyphenols are known, but, only when some of them can act synergistically, the benefits demonstrated by the Facta® technology become apparent.

The mechanism of action

 
 

The role of the Facta® technology

 

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.

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.

The Facta® properties make this technology unique and currently unsurpassable on the market and represent a significant competitive advantage for manufacturers who use it to process their medical devices, while enabling them to expand their market where a true product differentiation is extremely difficult to achieve.