sFilm-FS Fibrin sealant for anastomotic leaks and haemostasis

Summary

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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Web resources:	https://cordis.europa.eu/project/id/787441
Start date:	01-04-2018
End date:	31-03-2020
Total budget - Public funding:	2 003 388,00 Euro - 1 402 371,00 Euro

Cordis data

Original description

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.