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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.

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

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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