RE:RE:RE:RE:RE:New Press Release - Kane Biotech Announces Health Canada Approval of revyve(TM) Antimicrobial Wound Gel2. The spray does not contact the propellant, so no new permission is needed for its use. They don't need any more FDA permission after the July 23, 2024 decision lets them use the higher dosage that is in the spray can.
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US Food and Drug Administration (FDA) has eliminated its usage limitation on the Company’s 510(k) cleared revyve™ Antimicrobial Wound Gel (“revyve™”). Prior to the removal of this restriction, there was a 90 grams/month limit to the amount of revyve™ product that could be administered to patients. This now clears the way for the introduction and extended use of Kane’s revyve™ Antimicrobial Wound Gel Spray which is expected to be filled in spray cans in a higher quantity making it ideal for application on large wounds."