Gecko Biomedical obtains CE-Mark for SETALUM Sealant
French firm Gecko Biomedical has obtained CE-Mark to market its SETALUM Sealant in Europe.
The sealant is a biocompatible, bioresorbable on-demand activated polymer designed for use as an add-on to sutures in vascular surgery and can be activated with the firm’s light activation pen.
Based on natural adhesive mechanisms, the sealant features a bio-inspired technology developed by the Massachusetts Institute of Technology, Harvard Medical School, and Brigham and Women’s Hospital.
Gecko Biomedical CEO Christophe Bancel said: “Our ability to bring an entirely new family of innovative polymers from the bench to the bedside in less than two and a half years is a testimony to the versatility and scalability of our platform.
“We are now ready to fully expand, internally and through partnerships, into new therapeutic areas to design disruptive, surgical solutions for patients.”
The firm validated the safety and performance of the sealant in a prospective, single-arm and multi-centre clinical study (BlueSeal) at four university hospitals in the country.
BlueSeal included 22 patients who required carotid endarterectomy and assessed the polymer’s performance through immediate haemostasis percentage after clamp removal.
The results demonstrated optimal safety profile and immediate haemostasis in 85% patients without adverse sealant-related incidents.
BlueSeal principal investigator Jean-Marc Alsac said: “The SETALUM sealant can be precisely and easily applied thanks to its viscosity and hydrophobicity, and then activated at will to provide an instant hermetic barrier and effective haemostasis.”
Gecko has increased its manufacturing capabilities for the sealant and is working towards expanding applications for new functionalities, tissue types, clinical indications, and geographic markets.