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
Programme(s)
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Funding Scheme
SME-2 - SME instrument phase 2Coordinator
4809240 ROSH HAAYIN
Israel
The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.