Gecko Biomedical announced on Monday that it had received CE Mark Approval for its trademarked SETALUM Sealant technology. The Paris-based medical device company develops innovative polymers to support tissue reconstruction, and with this approval, now has the ability to begin marketing the technology throughout Europe. The approval essentially greenlights the company’s abilities to expand important development activities.
Gecko describes the BlueSeal sealant as “a biocompatible, bioresorbable and on-demand activated sealant usable in wet and dynamic environments as an add-on to sutures during vascular surgery. The polymer is applied to tissue in-situ and activated using a proprietary light activation pen.” The sealant uses tissue engineering, a relatively new technology, to achieve hemostasis—the process which causes a stop in bleeding—by using viscosity and hydrophobicity to create a barrier.
The technology for the sealant was the result of a joint collaboration between the Massachusetts Institute of Technology, Harvard Medical School, and Brigham and Women’s Hospital. A number of clinical studies involving four hospitals in Paris were carried out to confirm the effectiveness and applicability of the sealant, which Gecko designed “...with physicians and patients in mind, and [which] significantly improves upon the latest generation of hemostatic agents to become a gold standard in vascular surgery,” from a statement by Dr. Jean-Marc Alsac of the Paris-based Hôpital Européen Georges Pompidou. Dr. Alsac was also part of the clinical study measuring the hemostasis levels of the patients involved—a rate of 85% was reported.
The CE Marking involves a series of modules a company must go through in order to ensure that certain health, environmental protection as well as safety standards for Europe are met. Most importantly, many products can not be sold in Europe without achieving this distinction. The approval is the first of its kind for the company and lends great credibility to them as well to the important work that they do in developing polymer technology.
Gecko CEO Christophe Bancel said of the development:
“We are delighted to receive the CE Mark for our first 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 two[-]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.”
We will be following closely in the next few months the developments of the company as the contributions it will make are sure to be significant in rapidly developing area of biotechnology.