Descripción del proyecto
Una innovadora película polimérica para el control de fluidos corporales
Durante y después de una intervención quirúrgica se suelen presentar complicaciones como, por ejemplo, fugas anastomóticas y problemas de hemostasia. El equipo de Sealantium Medical Ltd trabaja en el desarrollo de una solución innovadora denominada sFilm-FS. Este innovador producto es una película polimérica biocompatible y bioabsorbible que contiene fibrinógeno humano liofilizado, trombina humana y cloruro cálcico. Su objetivo es controlar eficazmente la fuga de fluidos corporales durante las intervenciones quirúrgicas generales. El mecanismo principal de acción de sFilm-FS se basa en la capacidad de sellado de la película polimérica. En el proyecto sFilm-FS, financiado con fondos europeos, se continuará con el desarrollo del producto para demostrar su seguridad y eficacia en ensayos clínicos en seres humanos de fase I/II, incluidas las buenas prácticas de fabricación para su ampliación. El producto evitará complicaciones quirúrgicas y ahorrará tiempo, esfuerzo y riesgos.
Objetivo
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.
Ámbito científico
Programa(s)
Tema(s)
Convocatoria de propuestas
Consulte otros proyectos de esta convocatoriaConvocatoria de subcontratación
H2020-SMEINST-2-2016-2017
Régimen de financiación
SME-2 - SME instrument phase 2Coordinador
4809240 ROSH HAAYIN
Israel
Organización definida por ella misma como pequeña y mediana empresa (pyme) en el momento de la firma del acuerdo de subvención.