Kane Biotech completes submission for wound cleanser

Executive Summary

• Kane Biotech Inc. has completed the submission of a U.S. FDA 510(k) clearance application for its new revyve anti-microbial wound cleanser.
• The cleanser is the third product in the revyve line, designed to complement existing gel and spray products by providing irrigation to decrease bacterial load and remove loose material from acute and chronic wounds.
• The submission targets a U.S. market for wound cleansers that exceeded $200 million in 2024.

Key Details

• Submission Status: Completed submission of U.S. FDA 510(k) clearance for the revyve anti-microbial wound cleanser.
• Product Details:
  • Name: revyve anti-microbial wound cleanser.
  • Function: Irrigation for cleansing acute and chronic wounds to decrease bacterial load and remove loose material.
  • Formulation: Based on the existing revyve anti-microbial wound gel.
  • Positioning: Companion product to revyve anti-microbial wound gel and anti-microbial wound gel spray.
• Market Context: The annual U.S. market size for wound cleansers exceeded $200 million (U.S.) in 2024.
• Company Portfolio Status:
  • revyve anti-microbial wound gel: U.S. FDA 510(k) cleared.
  • revyve anti-microbial wound gel spray: U.S. FDA 510(k) cleared.
  • revyve anti-microbial wound gel: Health Canada approved.
  • Technology focus: Disrupting biofilms to transform healing outcomes and address antibiotic resistance.