Descrizione del progetto
Pellicola polimerica innovativa per il controllo dei fluidi corporei
Le complicazioni durante e dopo un intervento chirurgico, come le perdite anastomotiche e i problemi di emostasi, non sono rare. Sealantium Medical Ltd sta attualmente lavorando allo sviluppo di una soluzione innovativa chiamata sFilm-FS, ossia una pellicola polimerica biocompatibile e bioassorbibile che contiene fibrinogeno umano liofilizzato, trombina umana e cloruro di calcio. Lo scopo di questo prodotto innovativo è quello di controllare efficacemente la fuoriuscita di fluidi corporei durante gli interventi di chirurgia generale. Il meccanismo d’azione chiave di sFilm-FS si basa sulla capacità di tenuta della pellicola polimerica. Il progetto sFilm-FS, finanziato dall’UE, continuerà lo sviluppo del prodotto per dimostrarne la sicurezza e l’efficacia in studi clinici sull’uomo di fase I/II, comprese le buone pratiche di fabbricazione per l’aumento di scala. Il prodotto eviterà le complicazioni chirurgiche e farà risparmiare tempo, fatica e rischi.
Obiettivo
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.
Campo scientifico
Programma(i)
Argomento(i)
Invito a presentare proposte
Vedi altri progetti per questo bandoBando secondario
H2020-SMEINST-2-2016-2017
Meccanismo di finanziamento
SME-2 - SME instrument phase 2Coordinatore
4809240 ROSH HAAYIN
Israele
L’organizzazione si è definita una PMI (piccola e media impresa) al momento della firma dell’accordo di sovvenzione.