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Kane Biotech Completes U.S. FDA 510(k) Submission for revyve® Antimicrobial Wound Cleanser
Globenewswire· 2025-09-16 21:05
Core Insights - Kane Biotech Inc. has completed a U.S. FDA 510(k) clearance submission for its revyve Antimicrobial Wound Cleanser, marking a significant step in its product development [1][2] Product Development - The revyve Antimicrobial Wound Cleanser is the third product in the revyve line, complementing the existing revyve Antimicrobial Wound Gel and Antimicrobial Wound Gel Spray [2] - This new product aims to enhance routine wound management by providing irrigation to cleanse both acute and chronic wounds, thereby reducing bacterial load and removing debris [2] Market Opportunity - The annual U.S. market size for wound cleansers surpassed $200 million USD in 2024, indicating a substantial market opportunity for Kane Biotech's new product [3]
Kane Biotech Showcases revyve™ Preclinical and Clinical Case Study Findings at North American Wound Care Conferences
Globenewswire· 2025-07-30 12:00
Core Insights - Kane Biotech Inc. presented novel preclinical data and clinical case observations at major North American wound care conferences, showcasing the potential of its product revyve in wound care [1][2][3] Preclinical Data - In vitro studies demonstrated revyve's effectiveness in inhibiting key proteases, achieving over 80% reduction in matrix metalloproteinases (MMPs) activity, 82% reduction in elastase activity, and complete inhibition of collagenase and TACE [6][7] - Chronic wounds may exhibit TNF-α levels that exceed those in acute wounds by up to 100-fold, highlighting the need for effective treatments [2] Clinical Observations - Clinical case series indicated significant improvements in chronic wound patients using revyve, with clinically meaningful reductions in wound size and pain over a period of 6 to 12 weeks [6] - Specific cases reported include a 60% reduction in wound size over two months for a venous leg ulcer and complete pain elimination in a painful pressure wound [8] Conference Engagement - Kane Biotech engaged healthcare professionals at the NSWOCC and SAWC conferences, providing educational materials and product demonstrations of revyve [5][9] - The presentations aimed to reinforce the company's innovation in wound care and demonstrate the clinical value and commercial potential of revyve [9] Product Overview - Revyve is designed to address biofilms and wound bacteria, which are significant contributors to antibiotic resistance in wounds, potentially leading to serious clinical outcomes and high costs [9]
MIMEDX Announces Strategic Collaboration with Vaporox, Inc.
Globenewswire· 2025-07-30 12:00
Core Insights - MiMedx Group, Inc. and Vaporox, Inc. have announced a collaboration for co-promotion and co-marketing of their wound care products, with MiMedx making an investment in Vaporox and obtaining exclusivity rights for potential acquisition discussions [1][2][3] Company Overview - MiMedx is a leader in wound care, focusing on chronic and hard-to-heal wounds, with a vision to be the leading global provider of healing solutions through innovation [5] - Vaporox has developed the Vaporous Hyperoxia Therapy device, which combines ultrasonic mist and concentrated oxygen to treat chronic wounds, receiving FDA clearance for nine types of wounds [2][4] Strategic Goals - The collaboration aims to diversify MiMedx's portfolio and enhance treatment options for clinicians dealing with chronic wounds, leveraging Vaporox's technology alongside MiMedx's placental allografts [3] - Vaporox anticipates that the partnership with MiMedx will accelerate market penetration and create a synergistic offering to reach more patients [3] Clinical Efficacy - Vaporox's VHT has shown wound healing rates exceeding 80% at 20 weeks in clinical studies when used with standard wound care, indicating strong efficacy [3]