Kane Biotech experienced significant achievements in October 2022, for both their coactiv+™ and their DispersinB® technologies. For over 20 years, Kane has been developing new technologies and innovations, leading to 80 patents and patents pending in biotechnology focusing primarily on biofilm.
In October, Kane 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 (“FDA”), for a new Wound Care coactiv+™ Antimicrobial Hydrogel.
Kane device, which uses our patented coactiv+™ technology in a thermo-reversible gelling system, provides ease of use and is optimised for sensitive wounds. We aim to make the wound gel accessible to patients, taking into consideration current reimbursement levels under the surgical dressing policy in the U.S.
“This is yet another major milestone for Kane,” said Marc Edwards, President and Chief Executive Officer. “We are optimistic about the opportunities ahead as we expand Kane’s core technologies. I would like to recognize our team who have worked diligently on this initiative and continue to work through the FDA review process. I believe that this technology will be well-received by the FDA and help a lot of people suffering from chronic wounds.”
In October, Kane also received an additional $425,000 USD of funding for its DispersinB® Hydrogel related to its Medical Technology Enterprise Consortium Research Project Award (“MTEC”) which was granted in 2020 and funded by the U.S. Department of Defense. This additional funding supplements the approximately $2.7 million USD in non-dilutive funding previously awarded for the continued clinical development of Kane’s DispersinB® Hydrogel to treat biofilm-mediated antimicrobial resistance in non-healing chronic wounds.
“Biofilm formation is a common problem that significantly affects wound healing, thereby affecting military readiness. DispersinB® Hydrogel has shown great promise to inhibit biofilm formation, with the potential to promote wound closure and ultimately, accelerate return to duty. We are excited to see Kane Biotech’s technology progress into clinical studies and we anxiously await its safety evaluation in human subjects,” said Dr. Lauren Palestrini, Director of Research at the Medical Technology Enterprise Consortium. MTEC’s mission is to assist the U.S. Army Medical Research and Development Command by providing cutting-edge technologies and supporting effective life cycle management to transition medical solutions to industry that protect, treat, and optimize Warfighters’ health and performance across the full spectrum of military operations.
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.
1. Kresser, C. (2019, October 10). Biofilm: What it is and how to treat it. Kresser Institute. https://kresserinstitute.com/biofilm-what-it-is-and-how-to-treat-it/