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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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 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.

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

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 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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The information about "FACTA" are provided by the European Opendata Portal: CORDIS opendata.

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