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sFilm-FS SIGNED

Fibrin sealant for anastomotic leaks and haemostasis

Total Cost €

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EC-Contrib. €

0

Partnership

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 sFilm-FS project word cloud

Explore the words cloud of the sFilm-FS project. It provides you a very rough idea of what is the project "sFilm-FS" about.

clinical    lyophilized    proposing    hemostatic    degradable    fibrinogen    medical    demonstrates    provides    efforts    hemostasis    intended    ligature    components    preventing    sealantium    chloride    injured    models    prevention    fs    contain    absorbed    combination    leaks    ltd    adjunct    prognosis    rat    biological    cautery    glue    body    significantly    mode    shorter    unlike    anastomotic    standard    permeable    tested    gmp    action    saving    anastomosis    outcome    suture    surgery    continue    efficacy    film    demonstrating    tissue    capacity    absorbable    weeks    sfilm    contains    sealing    fluid    risks    thrombin    compatible    time    perfect    serve    stage    shifting    healing    bio    primary    leakage    impractical    intestinal    solutions    manufacturing    calcium    upscale    polymeric    commercial    surgical    pig    human    bleeding    solution    gastrointestinal    paradigm    soft    complications    trials    surgeries    staff    ineffective    profile    post    fixing    safety   

Project "sFilm-FS" data sheet

The following table provides information about the project.

Coordinator
SEALANTIUM MEDICAL LTD 

Organization address
address: 11 AMAL ST AFEK INDUSTRIAL PARK
city: ROSH HAAYIN
postcode: 4809240
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 Israel [IL]
 Project website http://www.sealantium-med.com/
 Total cost 2˙003˙388 €
 EC max contribution 1˙402˙371 € (70%)
 Programme 1. H2020-EU.2.1.4. (INDUSTRIAL LEADERSHIP - Leadership in enabling and industrial technologies – Biotechnology)
2. H2020-EU.2.3.1. (Mainstreaming SME support, especially through a dedicated instrument)
 Code Call H2020-SMEINST-2-2016-2017
 Funding Scheme SME-2
 Starting year 2018
 Duration (year-month-day) from 2018-04-01   to  2020-03-31

 Partnership

Take a look of project's partnership.

# participants  country  role  EC contrib. [€] 
1    SEALANTIUM MEDICAL LTD IL (ROSH HAAYIN) coordinator 1˙402˙371.00

Map

 Project objective

Sealantium Medical Ltd is developing a novel product, sFilm-FS, a bio-compatible bio-absorbable, polymeric film embedded with lyophilized Human Fibrinogen, Human Thrombin and calcium chloride. This novel product aimed to help controlling body fluid leakage in general surgery procedures, proposing its use as an adjunct to hemostasis and/or sealing. sFilm-FS is intended to be used for soft tissue bleeding during surgeries, when control of bleeding by standard surgical methods of hemostasis (suture, ligature, cautery) is ineffective or impractical. sFilm-FS is also intended for use as adjunct to sealing in gastrointestinal anastomosis procedures for prevention of leakage following intestinal anastomosis. sFilm-FS is a combination product based on a degradable, bio-compatible non-permeable polymeric film that contains biological components which serve as a glue fixing the film to its target tissue. Unlike other products which contain similar components, sFilm-FS primary mode of action is based on the sealing capacity of the polymeric film. sFilm-FS was tested in rat and pig models demonstrating high safety profile and effective hemostatic and sealing capabilities. The product was absorbed after two weeks without any side effects allowing perfect healing of the injured tissue. The objective of the project is to continue the development of the product to a stage which demonstrates the safety and efficacy of the product in phase I/II human clinical trials, including GMP manufacturing upscale. sFilm–FS will make surgical procedures shorter by preventing surgical complications, saving time, efforts and risks taken by the medical staff. sFilm-FS will also significantly improve the prognosis and outcome of various surgical procedures by preventing complications related to post-surgical bleeding or anastomotic leakage. The commercial potential in the project is large as it provides better solutions for hemostasis and a paradigm shifting solution for anastomotic leaks.

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