Magle Chemoswed announces that the Company submitted a final medical device Technical File to the appointed European Notified Body for CE mark approval of its SmartGel product. SmartGel is a non-allergenic chronic wound hydrogel based on the Company's unique microsphere technology, following initial review from the Notified Body in April 2020. SmartGel contains a known antimicrobial suspended in the biodegradable starch microspheres for optimal infection prevention and treatmen in chronic wounds. SmartGel is proven to deliver moisture to the wound while maintaining enough absorption capacity for exudate, debris and bacteria.
"I am very proud of the team's dedication in responding to the Notified Body's initial review of the final Technical File. This is another major milestone for Magle Chemoswed and is further strong evidence of the versatility of our technology platform," says Justin Pierce CEO of Magle Chemoswed.