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.
News Market Reaction
On the day this news was published, KNBIF gained 6.40%, reflecting a notable positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
KNBIF gained 6.4% with elevated volume, while selected biotech peers showed mixed moves: ORGS up 38.88%, TGRP up 27.59%, and others flat. Scanner data does not flag a coordinated sector move, suggesting the reaction was company-specific.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Nov 04 | Clinical data update | Positive | -24.8% | Strong revyve clinical and preclinical data presented at wound conferences. |
| Sep 16 | Regulatory submission | Positive | +20.1% | FDA 510(k) submission for revyve Antimicrobial Wound Cleanser in U.S. |
| Aug 28 | Earnings results | Negative | +13.6% | Q2 2025 revenue collapse and ongoing financing and credit challenges disclosed. |
| Jul 14 | Conference presentation | Neutral | -5.1% | Planned CEO presentation at Advanced Wound Care Summit USA announced. |
| Jun 18 | Corporate update | Negative | -20.2% | Distribution termination, PrairiesCan default notice, and loan restructuring plans. |
Kane’s news reactions have been mixed: positive revyve data on Nov 4, 2025 saw a -24.83% move, while an FDA submission on Sep 16, 2025 aligned with a 20.15% gain. Negative corporate updates, including loan defaults, have coincided with sharp declines.
Over the last six months, Kane Biotech has focused on its revyve wound care franchise while navigating financial and corporate challenges. Clinical and preclinical revyve data with strong efficacy metrics were presented at key conferences on Nov 4, 2025, but the stock fell 24.83%. The Sep 16, 2025 FDA 510(k) submission for the revyve Antimicrobial Wound Cleanser triggered a 20.15% rise. Financial results on Aug 28, 2025 showed sharply lower revenue of $27,997 and a smaller net loss, yet shares rose 13.55%. Today’s Health Canada approval adds another regulatory milestone to this trajectory.
Market Pulse Summary
The stock moved +6.4% in the session following this news. A strong positive reaction aligns with the clearly favorable nature of Health Canada’s approval for the revyve Antimicrobial Wound Gel Spray and the stock’s prior sensitivity to regulatory milestones, such as the 20.15% move on the FDA 510(k) submission. However, past episodes like the -24.83% reaction to strong clinical data and the company’s weak $27,997 quarterly revenue underscore ongoing fundamental and financing risks that could challenge the durability of gains.
Key Terms
510(k) process regulatory
AI-generated analysis. Not financial advice.
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?
Is revyve Antimicrobial Wound Gel Spray approved by the FDA and Health Canada for KNBIF?
What wound types is revyve approved to help manage in Canada (KNBIF)?
Will Kane Biotech (KNBIF) sell revyve in Canada immediately after approval?
Does Kane Biotech have other revyve products in regulatory review (KNBIF)?
How does Health Canada approval affect Canadian patients and clinicians for KNBIF?
