Kane Biotech Inc. announced that it has recently submitted a 510(k) premarket notification, which has been received by The Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration for a new Wound Care coactiv+™ Antimicrobial Hydrogel. The Company's device, which uses its patented coactiv+™ technology in a thermo-reversible gelling system, provides ease of use and is optimised for sensitive wounds. The Company aims to make the wound gel accessible to patients, taking into consideration current reimbursement levels under the surgical dressing policy in the U.S. Chronic wounds present a significant financial burden to the U.S. healthcare system.

The treatment of chronic wounds is a major challenge for health care providers, with a high failure rate leading to amputation, sepsis, and death. One of the major reasons for this failure is the formation of bacterial biofilms, which are present in over 80% of chronic wounds1. Biofilm formation can make bacteria up to 1,000 times more resistant to antibiotics, antimicrobial agents, disinfectants, and the host immune system.