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FACTA SIGNED

An innovative process to extend commercial bioprosthetic heart valves lifespan.

Total Cost €

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EC-Contrib. €

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Partnership

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Outcomes and
results

FACTA project word cloud

Explore the words cloud of the FACTA project. It provides you a very rough idea of what is the project "FACTA" about.

immunological requirement underwent maintaining propensity model epitope implant former seal disease 85 chain excellence treatments mhvs innovative efficacy constantly founders thrombogenicity grants morbidity financial durability valves mortality patients startup chemical latter vitro degeneracy calcification mechanical facta 850 resistance biocompatibility 2013 global irr xenoantigens 400 2022 mainly manufacturers patented heart flow confirm animal 11 perfectly structural raised correlation inactivating italian june causes clinical replacement 2017 bioprosthetic swine alpha market substitutes worldwide alarming bhvs pilot reported innovation valve 5m cagr premature ongoing tissue amounts protocol decrease toxicity npv industrialisation 71 2018 requiring bci 58 limit time biotechnology extensive reliability tolerability tissues investigations acute validated manufacture validation treatment biological bhv supply total physiological efficiency permanence commercial received gal

Project "FACTA" data sheet

The following table provides information about the project.

Coordinator	BIOCOMPATIBILITY INNOVATION SRL Organization address address: VIA ENRICO PETRELLA 4 city: PADOVA postcode: 35132 website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.
Coordinator Country	Italy [IT]
Project website	http://www.bio-compatibility.com
Total cost	71˙429 €
EC max contribution	50˙000 € (70%)
Programme	1. H2020-EU.3. (PRIORITY 'Societal challenges) 2. H2020-EU.2.3. (INDUSTRIAL LEADERSHIP - Innovation In SMEs) 3. H2020-EU.2.1. (INDUSTRIAL LEADERSHIP - Leadership in enabling and industrial technologies)
Code Call	H2020-SMEInst-2018-2020-1
Funding Scheme	SME-1
Starting year	2018
Duration (year-month-day)	from 2018-12-01 to 2019-05-31

Partnership

Take a look of project's partnership.

#	participants	country	role	EC contrib. [€]
1	BIOCOMPATIBILITY INNOVATION SRL BIOCOMPATIBILITY INNOVATION SRL Organization address address: VIA ENRICO PETRELLA 4 city: PADOVA postcode: 35132 website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	IT (PADOVA)	coordinator	50˙000.00

Map

Project 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%.

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