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CelaCare’s Novel Antimicrobial Wound Gel

CelaCare’s initial product is a clear, spreadable gel that the company plans to register as a professional Class II Medical Device for the management of first and second degree burns, surgical wounds, diabetic foot ulcers, venous leg ulcers and decubitus (pressure) ulcers. The potency of this gel has been evaluated against Staphylococcus aureus (both methicillin-resistant and non-resistant strains), Pseudomonas aeruginosa and Candida albicans, and compared to silver citrate alone (API), silver sulfadiazine (SSD) and miconazole (MZ). In the table below, the mean of the minimal inhibitory concentrations of total silver required for 99.9% kill is compared for the silver-containing preparations; for miconazole, the units reflect the concentration of the drug.

Tab - Antimicrobial Table

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Once FDA registration of the product is accomplished for human use, the company plans to also partner the product for veterinary use in the management of wounds.

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Pipeline

The company plans for follow-on products that include an OTC antimicrobial gel and a prescription gel for treatment of third degree burns, an indication in which CelaCare’s water-soluble product is expected to offer improved ease in cleaning wounds prior to changing dressings. Formulation development has been completed for both products. In addition, the company has initiated formulation development for an oral rinse to treat and manage cancer-associated oral mucositis and oral candidiasis.