Project description
Innovative polymeric film for body fluid control
Complications during and after surgery, such as anastomotic leaks and haemostasis issues, are not uncommon. Sealantium Medical Ltd is currently working on the development of a groundbreaking solution called sFilm-FS. This innovative product is a biocompatible, bio-absorbable polymeric film that contains lyophilised human fibrinogen, human thrombin and calcium chloride. It aims to effectively control the leakage of body fluids during general surgery procedures. The key mechanism of action for sFilm-FS relies on the sealing capacity of the polymeric film. The EU-funded sFilm-FS project will continue the development of the product to demonstrate its safety and efficacy in phase I/II human clinical trials, including Good Manufacturing Practice for upscaling. The product will prevent surgical complications and save time, effort and risks.
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.
Fields of science (EuroSciVoc)
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques. See: The European Science Vocabulary.
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques. See: The European Science Vocabulary.
- natural sciences chemical sciences inorganic chemistry alkaline earth metals
- medical and health sciences clinical medicine surgery surgical procedures
- natural sciences biological sciences genetics mutation
- natural sciences biological sciences genetics chromosomes
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Programme(s)
Multi-annual funding programmes that define the EU’s priorities for research and innovation.
Multi-annual funding programmes that define the EU’s priorities for research and innovation.
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H2020-EU.2.1.4. - INDUSTRIAL LEADERSHIP - Leadership in enabling and industrial technologies – Biotechnology
MAIN PROGRAMME
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H2020-EU.2.3.1. - Mainstreaming SME support, especially through a dedicated instrument
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Topic(s)
Calls for proposals are divided into topics. A topic defines a specific subject or area for which applicants can submit proposals. The description of a topic comprises its specific scope and the expected impact of the funded project.
Calls for proposals are divided into topics. A topic defines a specific subject or area for which applicants can submit proposals. The description of a topic comprises its specific scope and the expected impact of the funded project.
Funding Scheme
Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.
Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.
SME-2 - SME instrument phase 2
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Call for proposal
Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.
Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.
(opens in new window) H2020-SMEInst-2016-2017
See all projects funded under this callCoordinator
Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.
4809240 ROSH HAAYIN
Israel
The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.