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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.

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

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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