Sealantium’s First Pivotal Phase 1/2 Trial Published in the American Journal of Surgery
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: These […]
Sealantium & SimAbs Sign Quality Agreement, Advancing Toward GMP Manufacturing of sFilm-FS™
Sealantium Medical is proud to announce a key milestone in its collaboration with Belgian CDMO SimAbs, with the signing of a Quality Agreement that marks the successful completion of the first phase of the manufacturing preparation for sFilm-FS™. This agreement lays the foundation for GMP manufacturing and supports the preparation for large-scale clinical and commercial […]
Sealantium Medical announces completion of its phase I/II clinical study
Sealantium Medical has completed the enrolment of 32 patients to its randomized, open-label, comparator Phase I/II clinical study at four centers in the EU and the U.S. The study is evaluating the safety and efficacy of its flagship product, sFilm-FS, versus TachoSil, the market leading product, in controlling liver bleeding. Data from an interim analysis […]
Sealantium Medical successfully completes proof of concept study in minimally invasive surgery
Sealantium Medical announces the successful proof of concept of its novel, proprietary adapter device onto which sFilm-FS is mounted enabling the use of sFilm-FS in Minimal Invasive Surgery procedures (sFilm-FS/MIS). In this proof-of-concept pig study, sFilm-FS/MIS was shown to be useful and effective.
Sealantium Medical receives “Seal of Excellence” and a €1.4M grant from the European commission.
The EIC Seal of Excellence is an EU quality label for excellent ideas worthy of funding and is recognised increasingly by other national innovation programmes. Read more: https://research-and-innovation.ec.europa.eu/funding/funding-opportunities/seal-excellence_en
