Chemence Medical announced today that the FDA cleared its Exofin precision pen as a medical device for wound closure.
Alpharetta, Georgia-based Chemence said in a news release that the Exofin precision pen offers more versatility and exactness in closing wounds while also improving the ease of use in applying topical skin adhesive. It is available for immediate sale in the U.S.
The pen supplement’s Chemence’s portfolio of Exofin products, including the fast-drying 20ctyl cyanoacrylate topical adhesives with the highest viscosity formulation in the industry, the company said. Chemence offers new application methods, 30% increased viscosity and an industry-leading 14-day microbial barrier, it noted.
Chemence designed its Exofin pen as the only pen-style applicator on the market to feature an adjustable tip to allow the user to control the adhesive width by supporting three different application methods in one device: a micro-bristle brush for wide coverage, an inverted brush for narrow lines and an angle precision tip for micro lines.
The pen also includes an ergonomic design with a grooved non-slip surface, a pressure-controlled variable adhesive flow rate, a see-through activation chamber for viewing adhesive flow and the capacity to contain up to 152% more usable adhesive than other products, Chemence said.
“Doctors and surgeons emphasized they wanted an adhesive that could be applied with precision, regardless of the wound size or location, even in the most delicate procedures,” Chemence President Jeff Roberson said in the release. “We designed the Exofin precision pen to meet these needs by making it natural to hold, incorporating multiple applicators, and allowing doctors to vary the flow of adhesive with a pressure-controlled delivery system and higher viscosity formulation while maintaining the fast dry times of our other Exofin products.”