Mr. Ray Dupuis reports

KANE BIOTECH ANNOUNCES FDA 510(K) CLEARANCE FOR REVYVE(TM) ANTIMICROBIAL SKIN AND WOUND CLEANSER

Kane Biotech Inc. has passed 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 micro-organisms 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 non-sterile 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 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 health-care providers and patients, and ensures Kane is aligned with evolving regulatory expectations."

About Kane Biotech Inc.

Kane Biotech is commercializing and developing novel wound care treatments that disrupt biofilms and transform healing outcomes.

We seek Safe Harbor.