sFilm-FS · Fibrin sealant for anastomotic leaks and haemostasis

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