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

Rhea-AI Summary

Kane Biotech (TSX-V:KNE) has submitted a 510(k) clearance application to the FDA for its revyve® Antimicrobial Wound Cleanser. This marks the company's third product in the revyve line, complementing their existing Antimicrobial Wound Gel and Gel Spray products.

The new cleanser is designed for routine wound management, specifically for irrigating acute and chronic wounds to reduce bacterial load and remove loose material. The product's formulation is based on the existing revyve Antimicrobial Wound Gel. Notably, the U.S. wound cleanser market exceeded $200M USD in 2024.

Positive

• Expansion of product portfolio with third revyve product line offering
• Large market opportunity with U.S. wound cleanser market exceeding $200M USD
• Product complements existing revyve product line, creating potential synergies

Negative

• FDA approval pending and not guaranteed
• Entering a competitive wound care market

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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Website: kanebiotech.com

LinkedIn: https://www.linkedin.com/company/kanebiotech/

For more information:
Dr. Robert Huizinga	Ray Dupuis
Interim CEO	Chief Financial Officer
Kane Biotech Inc.	Kane Biotech Inc.
rhuizinga@kanebiotech.com	rdupuis@kanebiotech.com
(780) 970-1100	(204) 298-2200

Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

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.

FAQ

What is Kane Biotech's new FDA submission for?

Kane Biotech has submitted a 510(k) clearance application to the FDA for its revyve® Antimicrobial Wound Cleanser, designed for cleansing acute and chronic wounds.

What is the market size for wound cleansers in the US?

The U.S. wound cleanser market exceeded $200M USD in 2024.

How many products are in Kane Biotech's revyve product line?

The revyve® Antimicrobial Wound Cleanser is Kane Biotech's third product in the revyve line, alongside the Antimicrobial Wound Gel and Antimicrobial Wound Gel Spray.

What is the purpose of Kane Biotech's new wound cleanser?

The cleanser is designed for routine wound management, specifically for irrigating acute and chronic wounds to decrease bacterial load and remove loose material.

Is Kane Biotech's revyve Antimicrobial Wound Cleanser FDA approved?

No, Kane Biotech has just submitted its 510(k) clearance application to the FDA and is awaiting approval.