Kane Biotech Announces FDA 510(k) Clearance for revyve(TM) Antimicrobial Skin and Wound Cleanser

Executive Summary

• Kane Biotech received FDA 510(k) clearance for its revyve® Antimicrobial Skin and Wound Cleanser, expanding the company’s cleared wound‑care product line.
• The company broadened its ISO 13485:2016 certification (under MDSAP) to include distribution of wound cleansers, aligning with the new FDA Quality Management System Regulation.
• Both milestones validate Kane’s platform, support upcoming manufacturing scale‑up and sales activities later in 2026, and enhance its ability to pursue approvals in additional jurisdictions.

Key Details

• FDA 510(k) clearance granted for revyve® Antimicrobial Skin and Wound Cleanser, intended for cleansing, moistening, debriding, and removal of microorganisms/debris from acute & chronic dermal lesions (pressure ulcers, venous ulcers, diabetic foot ulcers, postsurgical wounds, burns, graft sites, minor cuts/abrasions, etc.).
• Manufacturing plan: Technology transfer and scale‑up of the cleanser slated for later 2026; sales activities to follow shortly thereafter.
• ISO 13485:2016 (MDSAP) expansion: Certification now covers distribution of wound cleansers in addition to existing non‑sterile antimicrobial wound dressings (revyve Antimicrobial Wound Gel & Spray).
• Regulatory context: Expansion aligns with FDA’s new Quality Management System Regulation (effective Feb 2026), harmonizing U.S. requirements with ISO 13485.
• Strategic impact: Enhanced regulatory standing enables Kane to pursue approvals across multiple jurisdictions and demonstrates continued investment in quality systems and operational readiness.

Notable Quotes

“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.”