Kane Biotech (TSX-V:KNE) Expands U.S. Reach on Regulatory and Distribution Progress

Highlights

• Kane Biotech is advancing its wound care platform through regulatory clearances, certification expansion, and new distribution agreements.
• The company has secured FDA 510(k) clearance for its revyve® Antimicrobial Skin and Wound Cleanser.
• Expanded ISO 13485/MDSAP strengthens regulatory compliance and distribution capabilities.
• New U.S. distribution agreements support broader market access.
• Peer-reviewed publication in the International Wound Journal validates revyve®’s antimicrobial and antibiofilm performance.
• Initial shipment preparations underway as Kane advances commercialization of its biofilm-focused wound care platform.

Kane Biotech Inc. (TSX-V:KNE), a Canada-based biotechnology company focused on disrupting biofilms in wound care, is rapidly advancing its commercial footprint in the U.S. following key regulatory milestones, expanded quality certifications, and new distribution agreements.

With FDA clearance secured, ISO certification expanded and preparations for initial shipments in the near term underway, the company’s revyve® product platform is gaining traction across both clinical and commercial pathways — positioning Kane for accelerated growth in the U.S. wound care market.

Targeting Biofilms — A Major Unmet Need in Wound Care

Chronic wounds remain a significant healthcare burden, often complicated by biofilms that contribute to antibiotic resistance and delayed healing. The company’s revyve® technology is specifically designed to disrupt biofilms while targeting wound bacteria, addressing a critical challenge in modern wound management.

The company recently received U.S. FDA 510(k) clearance for its revyve® Antimicrobial Skin and Wound Cleanser. The product is indicated for mechanical cleansing, moistening and debriding of acute and chronic dermal lesions, including the removal of microorganisms and debris.

This milestone strengthens Kane’s wound care portfolio and supports its product positioning in clinical settings across the US.

Quality Certification Scope Expanded

Kane expanded its ISO 13485:2016 certification under the Medical Device Single Audit Program (MDSAP) to include distribution and wound cleansers. The expansion builds on existing certifications for non-sterile antimicrobial wound dressings and aligns with the U.S. FDA’s Quality Management System Regulation introduced in February 2026.

The enhanced certification framework supports regulatory pathways across multiple jurisdictions and reflects the company’s continued investment in compliance and operational scale up and global market readiness.

Expanding U.S. Distribution Footprint

To drive market penetration, Kane has signed non-exclusive distribution and sales agreements for the revyve® Antimicrobial Wound Gel product line with Patient Care Medical in Texas and Life Biologics in New Jersey.

Life Biologics distributes nationally in advanced wound care, while Patient Care Medical focuses on hospitals and mobile wound care facilities across Louisiana, Mississippi and the Gulf Coast. Initial shipment preparations are underway.

Peer-Reviewed Validation Supports Clinical Adoption

Further strengthening its clinical profile, Kane announced publication of research on its revyve® Antimicrobial Wound Gel in the International Wound Journal. The study, led by Kane’s internal R&D team with contributors from the University of Miami’s Miller School of Medicine, examines the gel’s thermo-reversible properties, antimicrobial activity and antibiofilm performance.

The peer-reviwed publication provides independent validation of the product’s safety, in-vitro performance and clinical potential.

Positioned for 2026 Growth

With FDA clearance secured, ISO certification expanded, distribution agreements signed and peer-reviewed validation published, Kane Biotech is building multiple commercial catalysts heading into 2026.

By targeting biofilms — a core driver of chronic wound complications — the company is positioning revyve® as a differentiated solution in the growing advanced wound care market. The company’s  expanded ISO certification bolsters multi-market regulatory compliance, while peer-reviewed validation fuels clinician confidence and adoption.

As initial shipment preparations progress and distribution channels become operational, the company aims to build commercial traction on the back of its regulatory and operational advancements.

KNE shares traded at CAD 0.040 on February 24, 2026.