Kane Biotech Receives Health Canada Approval for revyve® Antimicrobial Wound Gel Spray

Rhea-AI Summary

Kane Biotech (OTC:KNBIF) announced that Health Canada approved revyve Antimicrobial Wound Gel Spray for use in Canada on December 10, 2025. The product was previously cleared under the FDA 510(k) process.

The approval gives Canadian clinicians and patients access to a new option for managing burns, large surface area wounds and ulcers, and the company said it will work with healthcare partners and distributors on access and education. Kane also noted a recent FDA submission for revyve Antimicrobial Wound and Skin Cleanser as a third product in the revyve line.

Positive

• Health Canada approval of revyve Antimicrobial Wound Gel Spray (Dec 10, 2025)
• Product previously cleared under FDA 510(k)
• Indication access for burns, large surface area wounds and ulcers in Canada
• Company pursuing commercial access via partners and distributors

Negative

• None.

WINNIPEG, Manitoba, Dec. 10, 2025 (GLOBE NEWSWIRE) -- Kane Biotech Inc. (TSX-V:KNE) (“Kane Biotech”, “Kane” or the “Company”) today announces that Health Canada has approved its revyve^® Antimicrobial Wound Gel Spray for use in Canada.

Health Canada approved revyve Antimicrobial Wound Gel Spray

revyve Antimicrobial Wound Gel Spray has been previously cleared under the FDA 510(k) process. This Health Canada approval represents another regulatory milestone for Kane and the Company’s commitment to advancing wound care innovation in Canada. The revyve Antimicrobial Wound Gel Spray is designed to support clinicians in managing complex wounds by helping to reduce microbial burden and promote a healthier wound environment.

Health Canada approval provides clinicians and patients in Canada with access to a new wound care option for managing burns, large surface area wounds and ulcers. The spray is part of Kane Biotech’s revyve wound care portfolio, which has been evaluated in multiple clinical settings in the United States.

Dr. Robert B. Huizinga, Interim CEO of Kane Biotech, commented, “Health Canada’s approval of the revyve Antimicrobial Wound Gel Spray is another step forward in our mission to improve outcomes for patients with chronic and hard-to-heal wounds. This approval validates the strength of our clinical data and provides Canadian healthcare providers with a new tool to address the burden of wound infections.”

The Company will work closely with healthcare partners and distributors to ensure appropriate access and education around the use of revyve Antimicrobial Wound Gel Spray. Kane Biotech continues to advance its wound care portfolio, including the recent FDA submission of revyve Antimicrobial Wound and Skin Cleanser as the Company’s third product in its revyve product line. 

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/

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For more information:

Dr. Robert Huizinga  Interim CEO Kane Biotech Inc. rhuizinga@kanebiotech.com (780) 970-1100	Ray Dupuis Chief Financial Officer   Kane Biotech Inc. rdupuis@kanebiotech.com (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.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/5d8b1ee8-17aa-461e-b855-8aa0088e8861

FAQ

What did Kane Biotech (KNBIF) announce on December 10, 2025 about revyve?

Kane announced that Health Canada approved revyve Antimicrobial Wound Gel Spray for use in Canada.

Is revyve Antimicrobial Wound Gel Spray approved by the FDA and Health Canada for KNBIF?

The spray was previously cleared under the FDA 510(k) process and now has Health Canada approval.

What wound types is revyve approved to help manage in Canada (KNBIF)?

Health Canada approval provides access for clinicians to manage burns, large surface area wounds and ulcers.

Will Kane Biotech (KNBIF) sell revyve in Canada immediately after approval?

The company stated it will work with healthcare partners and distributors to ensure access and education; no commercial launch date was provided.

Does Kane Biotech have other revyve products in regulatory review (KNBIF)?

Yes, the company reported a recent FDA submission for revyve Antimicrobial Wound and Skin Cleanser as a third product in the revyve line.

How does Health Canada approval affect Canadian patients and clinicians for KNBIF?

Approval gives clinicians and patients an additional wound care option intended to reduce microbial burden and support healthier wound environments.