Kane Biotech Secures FDA Approval For revyve® Wound Cleanser And Extends ISO 13485:2016 MDSAP Certification As FDA’s New QMSR Takes Effect

Kane Biotech Inc. announced that it has reached two significant regulatory milestones that strengthen its wound care platform and reinforce its focus on developing scientifically supported medical devices. These achievements mark an important step forward in the Company’s long-term strategy to expand its product offerings and improve patient outcomes.

The first milestone is the Company’s receipt of 510(k) clearance from the U.S. Food and Drug Administration for the revyve Antimicrobial Skin and Wound Cleanser. This product is intended for the mechanical cleansing, moistening, and debriding of skin wounds, as well as for removing foreign material such as microorganisms and debris. It is suitable for a wide variety of wound types, including acute and chronic injuries. These include Stage I–IV pressure ulcers, venous ulcers, leg ulcers, diabetic foot ulcers, surgical incisions, first-degree and superficial second-degree burns, graft and donor sites, minor cuts, minor burns, and superficial abrasions. The cleanser can also be used to moisten absorbent wound dressings, supporting proper wound bed preparation.

Kane Biotech plans to begin manufacturing technology transfer and scale-up for the cleanser toward the end of 2026, with commercial activities expected to follow soon after. This regulatory clearance serves as a strong confirmation of the progress and potential of the Company’s expanding revyve product line. The underlying technology platform is built to address both wound-related bacteria and biofilms, which are major factors in delayed healing and rising antibiotic resistance.

The second milestone is the expansion of Kane’s ISO 13485:2016 certification under the Medical Device Single Audit Program (MDSAP). The updated certification now includes distribution and has been broadened to cover wound cleansers, adding to the Company’s existing certifications for nonsterile antimicrobial wound dressings such as the revyve Antimicrobial Wound Gel and Wound Gel Spray. This update aligns Kane with the FDA’s new Quality Management System Regulation (QMSR), which came into effect in February 2026 and harmonizes U.S. quality system requirements with ISO 13485 standards used globally.

By expanding this certification, Kane strengthens its ability to pursue regulatory clearances in multiple international markets. It also demonstrates the Company’s ongoing investment in strong quality systems, regulatory compliance, and readiness for commercial expansion. According to Lori Christofalos, Chief Quality Officer, these achievements represent the Company’s disciplined approach to developing its wound care portfolio. She noted that maintaining compliance with ISO 13485 and MDSAP reinforces confidence among healthcare providers and patients while ensuring the Company remains aligned with evolving regulatory expectations.