Adhezion Biomedical LLC announced today that it received European CE Mark (Conformité Européene) approval for FloraSeal, a film-forming, cyanoacrylate-based microbial sealant in a ready-to-use applicator. CE is a mandatory European marking that indicates conformity with the essential health and safety requirements set out in European Directives.
FloraSeal is designed to help reduce the incidence of surgical site infections, a health care-associated infection (HAI). The World Health Organization (WHO) estimates that surgical site infections account for about 25% of HAIs. The burden of disease attributable to HAIs is huge, with hundreds of millions of patients affected worldwide every year. These infections contribute to patient deaths, disability and promote resistance to antibiotics.*
This is the second Adhezion Biomedical product to receive CE Mark approval. In February 2008, the CE Mark was awarded for SurgiSeal™ Topical Skin Adhesive which also recently received FDA clearance to market in the U.S. Adhezion Biomedical’s proprietary formulation can be used in a variety of applications including as an advanced microbial surgical sealant designed to create a protective barrier to immobilize bacteria and other pathogens. Other applications include topical skin adhesives designed to replace sutures, staples and bandages. The products require no refrigeration or blending, dry quickly and are very flexible. They are sold under the FloraSeal and SurgiSeal brands, targeted to surgeons and physicians.
“Having the CE Mark for FloraSeal will create great opportunities for us in the European market,” said Pete Molinaro, CEO of Adhezion Biomedical. “The CE Mark is recognized globally as an indicator of high product quality and good manufacturing practices. We are currently entering distribution agreements around the globe for FloraSeal and SurgiSeal.”
Source: Adhezion Biomedical