Mr. Marc Edwards reports

KANE BIOTECH ANNOUNCES FDA 510(K) CLEARANCE FOR ITS COACTIV+ ANTIMICROBIAL WOUND GEL

On May 24, 2023, Kane Biotech Inc. received 510(k) clearance of its coactiv+ anti-microbial 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), first- and second-degree burns, partial and full thickness wounds, large surface area wounds- and surgical incisions for adult populations.

"FDA clearance of our coactiv+ anti-microbial 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 $200-million (U.S.) U.S. anti-microbial 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 (United States) and Salud Pharma SA (Panama, Columbia and Costa Rica), we anticipate future global distribution agreements. This clearance triggers a $500,000 (U.S.) 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.

Chronic wounds present a significant financial burden to the U.S. health care system. Studies of Medicare data estimate the cost to treat these wounds at between $28-billion and $96-billion. 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 per cent of chronic wounds. Biofilm formation can make bacteria up to 1,000 times more resistant to antibiotics, anti-microbial agents, disinfectants and the host immune system. coactiv+ anti-microbial hydrogel will significantly increase the ability of health care clinicians to effectively treat chronic wounds and burns.

About coactiv+

coactiv+ anti-microbial wound gel is indicated for management of ulcers (including diabetic foot and leg ulcers and pressure ulcers), first- and second-degree burns, partial and full thickness wounds, large surface area wounds, and surgical incisions for adult populations. It is also indicated for management of minor skin scrapes, minor cuts, minor lacerations, minor burns (first-degree burns) and abrasions for adult populations.

coactiv+ anti-microbial wound gel is a white, odourless hydrogel that provides a moist wound environment conducive to wound healing. coactiv+ anti-microbial wound gel can facilitate debridement through a moist wound environment.

About Kane Biotech Inc.

Kane Biotech is a biotechnology company engaged in the research, development and commercialization of technologies and products that prevent and remove microbial biofilms. The company has a portfolio of biotechnologies, intellectual property (80 patents and patents pending, trade secrets, and trademarks) and products developed by the company's own biofilm research expertise and acquired from leading research institutions. StrixNB, DispersinB, Aledex, bluestem, silkstem, goldstem, coactiv+, DermaKB and DermaKB Biofilm are trademarks of Kane Biotech. The company is listed on the TSX Venture Exchange under the symbol KNE and on the OTCQB Venture Market under the symbol KNBIF.

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