Saturday, April 27, 2024

Saturday, April 27, 2024

TURN THERAPEUTICS: To File for FDA Clearance of Absorbent, Antimicrobial, Biologic Wound Matrix


Flex Antimicrobial  

Turn Therapeutics issued the following announcement on Dec. 31.

Turn Therapeutics, a noted innovator in advanced wound care, announced it has received positive data for its absorbent, antimicrobial regenerative wound matrix, known internally as Flex Antimicrobial. Flex employs a unique cold mixing process to fuse Turn's trusted, FDA cleared Hexagen antimicrobial formula with an FDA cleared regenerative collagen powder utilizing a 20%/80% ratio. This mix forms a first-of-its-kind, malleable product capable of stimulating healing while reducing bioburden and absorbing drainage.

"Combining regenerative properties with antimicrobial and absorbent capabilities is a first in the advanced wound care space," said Bradley Burnam, Turn Therapeutics CEO and Founder. "There are currently very limited options for reducing bioburden while stimulating healing through regenerative ingredients, and none that combine all the attributes Flex appears to offer. We expect to file for 510k clearance in the coming weeks and look forward to working with FDA to bring this product to clinicians."

In clinical testing, Flex Antimicrobial showed 99.999-99.9999% kill across a broad range of infectious organisms, showcasing its strong antimicrobial tendencies. The cold mixing process binds regenerative collagen to the lipid base of Hexagen (petrolatum), maintaining the integrity of the collagen while capitalizing upon Hexagen's known and trusted antimicrobial healing technology. The result is a 'fluffy snow' consistency that is capable of packing wounds versus simply applying dry form regenerative gauze to the affected area.

About Turn Therapeutics™:
Turn Therapeutics is a concept-to-approval research and development organization focused on novel, best in class products for infection control, skin disease, and wound care. The company's proprietary technologies are used every day by world-leading healthcare institutions to care for a variety of skin and wound conditions. For more information, visit www.turntherapeutics.com.

Original source can be found here.

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