improvements of bioprosthetic tissue
FACTA NOT PROMIses

With particular reference to biological implantable biomedical devices, BCI has made its efforts in the field of bioprosthetic heart valves substitutes (BHVs). BCI designed and developed two patented processes for the treatment of soft animal tissues currently used to BHVs manufacture with the aim to increase their duration. The treatment called FACTA is effective for the inactivation of a particular antigenic epitope: the alpha-Gal molecule. Such xenogeneic antigen resulted present in mammalian animal tissues (except in humans and higher primates) and is responsible for the onset of dystrophic phenomena that affect the behaviour of commercially available BHVs, limiting their life to about 10/12 years from the implant thus obliging both surgeons to a repetitive replacement of the prosthesis and patients to an even burdensome surgery.

The reliability and effectiveness of FACTA treatment has been validated by extensive in-vitro investigations confirming its ability in securing a new concept of biocompatibility (over 90% of permanently inactivated alpha-Gal epitopes) together with a significant decrease in calcification propensity (85% less of calcium deposits compared to untreated control) and better resistance to degenerative/degradative phenomena mediated by enzymes and oxidative stress. All data were reported in the scientific article entitled: “Alpha-Gal Inactivated Heart Valve Bioprostheses Exhibit an Anti-Calcification Propensity Similar to Knockout Tissues”, June 21, 2017 Tissue Engineering. The safety evaluation of the FACTA treatment is currently ongoing through the implant of FACTA treated commercial BHVs in a large animal model (swine) with a one-month short permanence time (assessment of the acute toxicity and immunological tolerability of the FACTA treatment). The animals that received the treated BHV showed a good tolerance, but the experimental phase is currently in progress.