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Kane Biotech Announces FDA 510(k) Clearance for revyve® Antimicrobial Skin and Wound Cleanser
WINNIPEG, Manitoba, Feb. 17, 2026 (GLOBE NEWSWIRE) -- Kane Biotech Inc. (TSXV:KNE) (“Kane ...
About this update from Kane Biotech Inc.
[{"type":"text","content":"Kane Biotech Announces FDA 510(k) Clearance for revyve® Antimicrobial Skin and Wound CleanserCompany expands ISO 13485/MDSAP Certification to support growing wound care portfolio\nWINNIPEG, 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 achievemen...