SETALIUM™ Vascular Sealant Shown to be Safe and Effective for Vascular Reconstruction
TISSIUM, a privately-owned life science company developing fully synthetic, biomorphic programmable polymers, announced today the publication of its manuscript detailing preclinical and clinical evaluations of SETALIUM™ Vascular Sealant, the company’s first synthetic, biodegradable, on-demand, light-activated sealant.
The results of these evaluations, published in The Journal of Cardiovascular Surgery on May 10th, 2019, ultimately showed that SETALIUM™ Vascular Sealant has good biocompatibility, good bioresorption, and a beneficial safety and efficacy profile.
SETALIUM™ Vascular Sealant is a new synthetic on-demand, light-activated poly (glycerol sebacate) acrylate (PGSA), and pre-clinical and clinical studies were designed to assess the biocompatibility of this product, as well as its performance in living subjects. Pre-clinical trials included three successful large animal studies during which open vascular carotid and aortic reconstruction surgeries were performed. With these promising results, clinical trials were initiated in patients requiring carotid endarterectomy using an ePTFE patch.
Biocompatibility testing demonstrated that standard clinical doses of the SETALIUM™ Vascular Sealant, and 40 times that dose, did not induce any significant toxic reaction. Animal studies produced excellent performance and safety data. Clinically significant hemostasis was achieved in 100% of the animals across carotid and aorta studies. In clinical studies, immediate hemostasis was achieved in 84% of cases with no devicerelated adverse events reported.
As a result, the SETALIUM™ Vascular Sealant showed good biocompatibility, and an acceptable safety profile. In human trials, it was shown to be a safe and effective option that can achieve fast hemostasis in vascular carotid reconstructions.
Christophe Bancel, CEO of TISSIUM said: “We are delighted to have the opportunity to share this manuscript and our findings in The Journal of Cardiovascular Surgery. Our pre-clinical and clinical trials have yielded promising results for SETALIUM™ Vascular Sealant, for which we plan commercialization in Europe in the fourth quarter of this year. This publication of our findings validates our progress and affirms the non-toxic, biocompatible, and performance that we have highlighted since the launch of our platform. We’re pleased with our success thus far and look forward to expanding the utility of TISSIUM’s Biomorphic Programmable Polymers in additional new applications with further clinical trials.”