Chemence Medical said yesterday it won FDA 510(k) for its Exofin topical skin adhesive designed for wound closure.
The Alpharetta, Ga.-based company said it will offer the Exofin sealant in 2 sizes, and claimed the product is the “fastest polymerizing 2-octyl cyanoacrylate topical adhesive” available, with the highest viscosity formulation.
“After spending more than 2 years observing and talking to healthcare professionals throughout all departments of hospitals across America, it became clear that no single topical adhesive had all of the attributes that mattered most. Chemence Medical has combined your feedback with the very best R&D department in the USA and created a topical skin adhesive that delivers on all of the requirements you asked for,” prez Jeff Roberson said in a press release.
The company offers the Exofin with a “soft and flexible” applicator with a transparent tip Chemence said will enable the operator to see the adhesive prior to expression to allow for a solid seal.
“Exofin delivers the speed, strength and innovation customers have asked for while being easy to use. Chemence Medical is excited to introduce the next generation of topical skin adhesive,” Roberson said in prepared remarks.