Kane Biotech Announces FDA 510(k) Clearance for its coactiv+ Antimicrobial Wound Gel

Kane’s first FDA cleared medical device aims to disrupt global wound care hydrogel market

WINNIPEG, Manitoba, May 25, 2023 (GLOBE NEWSWIRE) -- Kane Biotech Inc. (TSX-V:KNE OTCQB:KNBIF) (the “Company” or “Kane Biotech”) announces that on May 24, 2023 it received 510(k) clearance of its coactiv+ Antimicrobial Wound Gel from the U.S. Food and Drug Administration (FDA) for the management of ulcers (including diabetic foot and leg ulcers and pressure ulcers), 1^st and 2^nd degree burns, partial & full thickness wounds, large surface area wounds and surgical incisions for adult populations.

“FDA clearance of our coactiv+ Antimicrobial Wound Gel, is a major milestone for Kane,” said Marc Edwards, President and Chief Executive Officer. “We’re bringing an effective, differentiated, and accessible product to the annual USD $200 million¹ U.S. antimicrobial wound hydrogel market. This clearance also opens the door for a large number of global markets. Building on our previously announced agreements with ProgenaCare Global LLP (“ProgenaCare”) (United States) and Salud Pharma S.A. (Panama, Columbia and Costa Rica), we anticipate future global distribution agreements. This clearance triggers a USD $500,000 initial payment from ProgenaCare which it anticipates receiving later this month.”

“We recently introduced our coactiv+ gel to potential distribution and licensing partners at both the Symposium on Advanced Wound Care (SAWC) in Washington in late April 2023 and the European Wound Management Association (EWMA) in Milan, Italy in May 2023 and it was very well received,” said Mr. Edwards.

“coactiv+ is a triple threat combination of: (1) EFFICACY thanks to Kane Biotech’s patented coactiv+ technology; (2) EASE OF USE due to its thermo-gelling properties that’s easy to apply, stays on the wound and is easy to remove; (3) ACCESSIBILITY as Kane intends to offer its gel at a price point that fits within Medicare and private payer allowables. It should be very well received by practitioners as it checks all the boxes,” said Dr Greg Schultz, Kane’s Chief Scientific Officer.

More information about Kane’s coactiv+ Antimicrobial Wound Gel can be found at www.coactivplus.com.

Chronic wounds present a significant financial burden to the U.S. healthcare system. Studies of Medicare data estimate the cost to treat these wounds at between $28 billion and $96 billion². The treatment of chronic wounds is a major challenge for health care providers, with a high failure rate leading to amputation, sepsis, and death. One of the major reasons for this failure is the formation of bacterial biofilms, which are present in over 80% of chronic wounds³. Biofilm formation can make bacteria up to 1,000 times more resistant to antibiotics, antimicrobial agents, disinfectants, and the host immune system. coactiv+ Antimicrobial Hydrogel will significantly increase the ability of healthcare clinicians to effectively treat chronic wounds and burns.