Gecko Biomedical said today it won CE Mark approval in the European Union for its Setalum Sealant designed for use during vascular surgery.
The Paris-based company said Setalum is a biocompatible, bioresorbable sealant designed as an add-on to sutures, and is usable in wet and dynamic environments and activated using a light activation pen. The CE Mark approval marks the 1st regulatory win for Gecko Biomedical’s Setalum, the company said.
“We are delighted to receive the CE Mark for our 1st product, Setalum sealant, as this will allow us to bring new and innovative solutions to the market to improve patient care. As a result, we are now ramping up our manufacturing capabilities and selection of strategic partners to bring this innovation to patients. Our ability to bring an entire new family of innovative polymers from the bench to the bedside in less than 2 and a half years, is a testimony of 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,” Gecko CEO Christophe Bancel said in a press release.
Setalum is based off technology developed at the Massachusetts Institute of Technology, Harvard Medical School and Brigham and Women’s Hospital, the company said.
Results from the BlueSeal clinical study of the sealant used during carotid endarterectomy procedures indicated that immediate hemostasis was achieved in 85% of patients, with all recorded adverse events “found to be representative of those commonly occurring in patients necessitating vascular reconstruction” and unrelated to the sealant, the company 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 hemostasis. The key features of this polymer technology were selected with physicians and patients in mind, and significantly improves upon the latest generation of hemostatic agents to become a gold standard in vascular surgery,” BlueSeal clinical study principal investigator Dr. Jean-Marc Alsac of Paris’ the Hôpital Européen Georges Pompidou said in a prepared statement.
Gecko said it is looking to expand its application of the sealant and seek new clinical indicaitons and clearances in new markets.
Last June, Gecko said it landed a $1.6 million, interest-free loan from Bpifrance to support its development of surgical sealants.