Kane Biotech Inc. (KNBIF) announced that the U.S. FDA has granted 510(k) clearance for its revyve Antimicrobial Skin and Wound Cleanser, marking a key regulatory milestone for the company's expanding wound-care portfolio.
The cleanser is cleared for mechanical cleansing, moistening, debriding, and removal of microorganisms and debris from a wide range of acute and chronic dermal lesions, including pressure ulcers, venous ulcers, diabetic foot ulcers, surgical wounds, burns, graft sites, and minor abrasions.
The company noted that the clearance validates the broader revyve platform, which is designed to address both wound bacteria and biofilms- two major contributors to delayed healing and antibiotic resistance. Manufacturing scale-up and technology transfer are planned for later in 2026, with commercial activities expected to follow.
Kane Biotech also expanded its ISO certification under the Medical Device Single Audit Program (MDSAP) to include distribution and wound cleansers, aligning with the FDA's new Quality Management System Regulation that harmonizes U.S. requirements with ISO 13485. The company said this strengthens its ability to pursue regulatory approvals across multiple jurisdictions.
Kane Biotech develops wound-care products targeting biofilms, a major driver of antibiotic resistance and poor healing outcomes. The revyve product line- including the Antimicrobial Wound Gel and Wound Gel Spray- is already FDA-cleared, with additional approvals from Health Canada.
KNBIF has traded between $0.02 and $0.07 over the past year. The stock is currently trading at $0.02, down 1.69%.
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