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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.

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

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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