Kane Biotech Announces FDA 510(k) Clearance for revyve® Antimicrobial Skin and Wound Cleanser
Rhea-AI Summary
Kane Biotech (OTC:KNBIF) received U.S. FDA 510(k) clearance for revyve® Antimicrobial Skin and Wound Cleanser, cleared for mechanical cleansing and debridement across a broad range of acute and chronic dermal lesions.
Manufacturing technology transfer and scale-up are planned later in 2026, and Kane expanded ISO 13485:2016/MDSAP certification to include distribution and wound cleansers, aligning with the FDA QMSR effective February 2026 to support multi‑jurisdiction regulatory filings.
Positive
- FDA 510(k) clearance obtained for revyve Antimicrobial Skin and Wound Cleanser
- ISO 13485:2016/MDSAP expanded to include distribution and wound cleansers
- Manufacturing technology transfer and scale-up planned later in 2026
Negative
- None.
News Market Reaction – KNBIF
In the trading session that priced this news, KNBIF declined 5.52%, reflecting a notable negative market reaction.
Data tracked by StockTitan Argus on the day of publication.
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Company expands ISO 13485/MDSAP Certification to support growing wound care portfolio
WINNIPEG, Manitoba, Feb. 17, 2026 (GLOBE NEWSWIRE) -- Kane Biotech Inc. (TSXV:KNE) (“Kane Biotech”. “Kane” or the “Company”) today announces two regulatory milestones that strengthen the Company’s wound care platform and reinforce its commitment to high quality, evidence-based medical device development.
Kane has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its revyve® Antimicrobial Skin and Wound Cleanser, intended for the mechanical cleansing, moistening, debriding, and removal of foreign material — including microorganisms and debris — from a broad range of acute and chronic dermal lesions. These include Stage I–IV pressure ulcers, venous ulcers, leg ulcers, diabetic foot ulcers, postsurgical wounds, first and superficial second-degree burns, grafted and donor sites, as well as minor cuts, minor burns, and superficial abrasions. The cleanser is also intended for moistening absorbent wound dressings. With manufacturing technology transfer and scale-up of the cleanser planned for later in 2026 and sales activities shortly thereafter, this clearance represents an important validation of Kane’s expanded revyve product line. The technology platform is designed to address both wound bacteria and biofilms — two major contributors to delayed healing and antibiotic resistance.
In addition, Kane has expanded its ISO 13485:2016 certification under the Medical Device Single Audit Program (MDSAP) to include distribution while expanding to wound cleansers, building on its existing certifications for nonsterile antimicrobial wound dressings (revyve Antimicrobial Wound Gel and revyve Antimicrobial Wound Gel Spray). This expansion is aligned with the FDA’s new Quality Management System Regulation (QMSR) which came into effect February 2026, harmonizing U.S. requirements with ISO 13485.
The expanded certification supports Kane’s ability to pursue regulatory approvals across multiple jurisdictions and demonstrates the Company’s continued investment in quality systems, compliance, and operational readiness.
“These achievements reflect Kane’s disciplined approach to advancing its wound care portfolio,” said Lori Christofalos, Chief Quality Officer. “ISO 13485 and MDSAP compliance strengthens trust among healthcare providers and patients, and ensures Kane is aligned with evolving regulatory expectations.”
About Kane Biotech Inc. (TSX-V:KNE)
Kane Biotech is commercializing and developing novel wound care treatments that disrupt biofilms and transform healing outcomes. Biofilms are one of the main contributors to antibiotic resistance in wounds, resulting in serious clinical outcomes and significant cost. revyve® addresses both biofilms and wound bacteria. revyve® Antimicrobial Wound Gel, revyve® Antimicrobial Wound Gel Spray and revyve® Antimicrobial Skin and Wound Cleanser are all U.S. FDA 510(k) cleared. revyve® Antimicrobial Wound Gel and revyve® Antimicrobial Wound Gel Spray are also Health Canada approved. To learn more, visit revyvegel.com or revyvegel.ca.
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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.sedarplus.ca. The Company cautions that the foregoing list of factors that may affect future results is not exhaustive.
