Wound Care System, FDA 510k Approved
Phytacare Wound Dressing - Phytacare®, is an FDA-approved 510k wound dressing with an all-natural base. In a pilot clinical trial, the Phytacare® wound dressing facilitated wound healing of diabetic ulcers following topical application substantially better than the Regranex® Becaplermin Gelone of the leading wound care therapy (85% for Phytacare® vs 32% for Regranex®) which was used as the active control. On June 6, 2008, the FDA announced new labeling changes for Regranex® to carry a boxed warning for a five-fold increased cancer risk for patients who use three or more tubes of the drug. Regranex® is the leading seller and only approved drug product in its category, underscoring a major market opportunity for the Company.
Curaderm® Skin Revitalization Cream - The Curaderm® Skin Revitalization Cream is a skin protectant that contains the same active natural base as the Phytacare® product and is an ulcer aftercare therapy to prevent the reopening of healed skin ulcers. It can also be used to revitalize dry, troubled and problem skin. The Phytacare® and Curaderm® products can be marketed together as a treatment for skin ulcers.
OTC Antiseptic Wound Cleanser – The wound cleanser contains a novel combination of safe, natural antimicrobial ingredients that cleans the wound and penetrates wound bio-films to reduce wound bio-burden before application of the Phytacare gel.