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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.

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

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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