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news.Adhezion Biomedical, a medical device company, has received European CE Mark approval for FloraSeal, a film-forming, cyanoacrylate-based microbial sealant in a ready-to-use applicator.
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According to Adhezion Biomedical, FloraSeal is designed to help reduce the incidence of surgical site infections, a healthcare-associated infection.
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 US.
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.
Pete Molinaro, CEO of Adhezion Biomedical, said: “Having the CE Mark for FloraSeal will create great opportunities for us in the European market. 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.”