Project description DEENESFRITPL A novel treatment will be making hearts sing longer and stronger The heart contracts and relaxes about 100 000 times per day. This hard work can take its toll on the valves of the heart, which act like gatekeepers of each chamber, opening to allow blood in during contraction and closing to ensure it does not flow backward during relaxation. When heart valve disease impairs blood flow and the valve(s) must be replaced, two types of prosthetic valves are available: one completely synthetic and one using animal tissue. The latter, bioprosthetic heart valves (BHVs), can exhibit structural degradation over time, which is particularly problematic in younger patients with longer life expectancies. FACTA is a treatment that enhances the durability of BHVs. The EU-funded FACTA project is supporting the development of the business plan to get it to patients who need it and help them avoid a second surgery. Show the project objective Hide the project objective Objective "Heart valve disease is one of the main causes of morbidity and mortality worldwide. In 2017 around 400.000 patients underwent heart valve replacement. Mechanical (MHVs) and Bioprosthetic (BHVs) Heart Valves are the most used substitutes. However, the former have problems related to their thrombogenicity, the latter durability issues that limit their use.Recently an alarming correlation between the presence of the alpha-Gal epitope and a premature BHVs degeneracy was reported.BioCompatibility Innovation (BCI), an Italian biotechnology Startup, aims to bring on the market FACTA: an innovative treatment for inactivating the alpha-Gal xenoantigens in biological tissues that can be used to manufacture BHVs substitutes. FACTA has been patented and its reliability and efficacy have been validated by extensive in-vitro investigations that confirm a significant decrease in calcification propensity (over 85%) and a better resistance of the treated tissue, compared to the current chemical treatments of BHVs manufacturers. Currently a pilot study is ongoing, involving the implant of commercial BHVs treated with the FACTA protocol in swine with a one-month short permanence time (assessment of the acute toxicity and immunological tolerability of the FACTA treatment). BCI will evaluate a more in-depth validation of maintaining the physiological/structural efficiency of FACTA treated BHVs in an animal model implant for the expected 6-month duration.The global BHVs market is constantly growing: 11.71% CAGR between 2013 and 2022. FACTA can be perfectly integrated into the production flow of BHV manufacturers, without requiring any change in the supply chain. BCI raised about 850.000 € by founders and grants. FACTA received the ""Seal of Excellence"" by European Commission in June 2018. The total financial requirement amounts to about 2.7 M€, mainly for clinical validation and product industrialisation over 2 years, with a NPV of over 8.5M€ and an IRR of 58%." Fields of science medical and health sciencesclinical medicinesurgerynatural scienceschemical sciencesinorganic chemistryalkaline earth metalsmedical and health sciencesclinical medicinenephrologymedical and health sciencesmedical biotechnologytissue engineeringmedical and health sciencesbasic medicineimmunology Programme(s) H2020-EU.2.3. - INDUSTRIAL LEADERSHIP - Innovation In SMEs Main Programme H2020-EU.3. - PRIORITY 'Societal challenges H2020-EU.2.1. - INDUSTRIAL LEADERSHIP - Leadership in enabling and industrial technologies Topic(s) EIC-SMEInst-2018-2020 - SME instrument Call for proposal H2020-EIC-SMEInst-2018-2020 See other projects for this call Sub call H2020-SMEInst-2018-2020-1 Funding Scheme SME-1 - SME instrument phase 1 Coordinator BIOCOMPATIBILITY INNOVATION SRL Net EU contribution € 50 000,00 Address VIA ENRICO PETRELLA 4 35132 PADOVA Italy See on map SME The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed. Yes Region Nord-Est Veneto Padova Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Links Contact the organisation Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost € 71 429,00
