Kane Biotech Completes U.S. FDA 510(k) Submission for revyve® Antimicrobial Wound Cleanser

WINNIPEG, Manitoba, Sept. 16, 2025 (GLOBE NEWSWIRE) -- Kane Biotech Inc. (TSX-V:KNE) (“Kane Biotech” or the “Company”) today announces that it has completed a U.S. Food and Drug Administration (“FDA”) 510(k) clearance submission for its revyve® Antimicrobial Wound Cleanser.

revyve Antimicrobial Wound Cleanser is the Company’s third product in its revyve product line and complimentary to Kane’s revyve Antimicrobial Wound Gel and Antimicrobial Wound Gel Spray products. This new companion product will be part of routine wound management, providing irrigation for the purpose of cleansing acute and chronic wounds to decrease the bacterial load and remove loose material. The formulation of the cleanser is based on revyve Antimicrobial Wound Gel.

The annual U.S. market size for wound cleansers exceeded $200M USD in 2024.1 2 3

1 https://www.theresearchinsights.com/reports/u-s-wound-wash-market-542
2 https://www.researchandmarkets.com/reports/6055956/u-s-wound-wash-market-size-share-and-trends
3 https://www.credenceresearch.com/report/wound-wash-market

About Kane Biotech Inc. (TSX-V: KNE)

Kane Biotech is developing novel wound care treatments that disrupt biofilms and transform healing outcomes. Biofilms are one of the main contributors to antibiotic resistance in wounds which results in serious clinical outcomes and significant cost. revyve® addresses both biofilms and wound bacteria. revyve® Antimicrobial Wound Gel and revyve® Antimicrobial Wound Gel Spray are US FDA 510(k) cleared. revyve® Antimicrobial Wound Gel is Health Canada approved. To learn more about revyve, visit revyvegel.com or revyvegel.ca.

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For more information: 
  
Dr. Robert HuizingaRay Dupuis
Interim CEOChief Financial Officer
Kane Biotech Inc.Kane Biotech Inc.
rhuizinga@kanebiotech.comrdupuis@kanebiotech.com
(780) 970-1100(204) 298-2200


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Caution Regarding Forward-Looking Information
This press release contains certain statements regarding Kane Biotech Inc. that constitute forward-looking information under applicable securities law. These statements reflect management’s current beliefs and are based on information currently available to management. Certain material factors or assumptions are applied in making forward-looking statements, and actual results may differ materially from those expressed or implied in such statements. These risks and uncertainties include, but are not limited to, risks relating to the Company’s: (a) financial condition, including lack of significant revenues to date and reliance on equity and other financing; (b) business, including its early stage of development, government regulation, market acceptance for its products, rapid technological change and dependence on key personnel; (c) intellectual property including the ability of the Company to protect its intellectual property and dependence on its strategic partners; and (d) capital structure, including its lack of dividends on its common shares, volatility of the market price of its common shares and public company costs. Further information about these and other risks and uncertainties can be found in the disclosure documents filed by the Company with applicable securities regulatory authorities, available at www.sedar+.ca. The Company cautions that the foregoing list of factors that may affect future results is not exhaustive.


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