The company is all set to seek 510k clearance from the US Food and Drug Administration (FDA).
Flex blends Turn’s FDA-cleared Hexagen antimicrobial formula with an FDA-cleared regenerative collagen powder through a cold mixing process in a ratio of 20%:80%
The combination results in a first-of-its-kind, malleable product that can potentially stimulate healing while absorbing drainage and lowering bioburden.
Turn Therapeutics CEO and founder Bradley Burnam said: “Combining regenerative properties with antimicrobial and absorbent capabilities is a first in the advanced wound care space.
“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 the FDA to bring this product to clinicians.”
The company noted that Flex Antimicrobial exhibited a 99.999-99.9999% kill rate, including various infectious organisms, demonstrating its robust antimicrobial properties in clinical testing.
The cold mixing process attaches regenerative collagen to the lipid base of Hexagen (petrolatum), preserving the integrity of the collagen while benefiting from Hexagen’s known and trusted antimicrobial healing technology.
The resulting product is like ‘fluffy snow’, which is capable of packing wounds far better than using dry form regenerative gauze to the affected area.
A concept-to-approval research and development organisation, Turn Therapeutics focuses on new, best-in-class products for infection control, wound care, and skin disease.
Its proprietary technologies are being used on a daily basis to care for various skin infections and wounds in many healthcare institutions.