Sealantium Medical is proud to announce the publication of its first pivotal Phase 1/2 randomized controlled multicenter trial in the peer-reviewed American Journal of Surgery. This landmark study compared sFilm-FS™, Sealantium’s dual-acting fibrin sealant patch, with Tachosil®, a leading hemostatic agent, in elective liver surgery.
The results highlight a significant advance in surgical biomaterials:
- Faster hemostasis – median 2 minutes with sFilm-FS™ versus 3 minutes with Tachosil®
- 100% success rate in achieving bleeding control within 10 minutes
- Excellent safety and tolerability across all patients
These findings demonstrate the potential of sFilm-FS™ to enhance surgical efficiency, reduce bleeding risks, and improve outcomes in hepatobiliary procedures – one of the most critical and challenging areas of surgery. By combining mechanical sealing with fibrin-based hemostasis, sFilm-FS™ offers a next-generation approach designed to meet the needs of both open and minimally invasive operations.
“This trial marks a major step forward in biomaterial innovation for surgery and reinforces our commitment to delivering safer, more effective tools for bleeding control,” said Chris Lamb, CEO of Sealantium Medical. “We are proud to contribute peer-reviewed evidence that advances the standard of care and supports surgeons in the most demanding procedures.”
The study was conducted with leading investigators across the U.S., Europe, and Israel – underscoring Sealantium’s collaborative approach to innovation.
As Sealantium advances toward Phase III clinical studies, the publication of this trial adds to the growing body of evidence positioning sFilm-FS™ as a next-generation hemostatic solution with the potential to transform surgical practice.
Read the full clinical paper here
