Description du projet
Film polymère innovant pour le contrôle des fluides corporels
Les complications pendant et après l’opération, telles que les fuites anastomotiques et les problèmes d’hémostase, ne sont pas rares. Sealantium Medical Ltd travaille actuellement au développement d’une solution révolutionnaire appelée sFilm-FS. Ce produit innovant est un film polymère biocompatible et bio-absorbable qui contient du fibrinogène humain lyophilisé, de la thrombine humaine et du chlorure de calcium. Il vise à contrôler efficacement les pertes de fluides corporels pendant les interventions de chirurgie générale. Le principal mécanisme d’action du sFilm-FS repose sur la capacité d’étanchéité du film polymère. Le projet sFilm-FS, financé par l’UE, poursuivra le développement du produit afin de démontrer sa sécurité et son efficacité lors des essais cliniques de phase I/II chez l’homme, y compris les bonnes pratiques de fabrication pour sa mise à l’échelle. Le produit évitera les complications chirurgicales, ce qui se traduira par un gain de temps et d’énergie, et une réduction des risques.
Objectif
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.
Champ scientifique
Programme(s)
Thème(s)
Régime de financement
SME-2 - SME instrument phase 2Coordinateur
4809240 ROSH HAAYIN
Israël
L’entreprise s’est définie comme une PME (petite et moyenne entreprise) au moment de la signature de la convention de subvention.