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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.

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

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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