Turn Therapeutics to File FDA Submission for Antimicrobial Wound Matrix
Turn Therapeutics has announced that it will file for 510(k) clearance “in the coming weeks” for its Flex Antimicrobial regenerative wound matrix.
The Los Angeles company said it intends to file for marketing clearance after seeing positive data for Flex, a product that combines the firm’s Hexagen antimicrobial formula with a regenerative collagen powder that have both been separately cleared by the FDA.
The malleable wound matrix is designed to spur healing while reducing bioburden and absorbing drainage. It has a “fluffy snow” consistency that can be used to pack wounds instead of applying regenerative gauze to the affected area.