Skin science company Omeza reported on Thursday the receipt of clearance for its Omeza Collagen Matrix (OCM) from the US Food and Drug Administration's (FDA) 510(k) premarket notification process to protect and manage chronic wound care.
The company said that the Omeza Collagen Matrix (OCM) is the first Rx product and the first drug/device combination matrix of its kind for chronic wound care. The OCM is a wound care matrix comprised of hydrolyzed fish collagen infused with cod liver oil, which acts as an anhydrous skin protectant, and other plant-derived oils and waxes. Upon application, the matrix is naturally incorporated into the wound over time. The product features a no-prep application supplied in easy to use, unit dose vials.
In addition, the company said the OCM is indicated for the partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds, donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds, abrasions, lacerations, superficial partial thickness burns, skin tears and draining wounds.
According to the American Diabetes Association (ADA), over 9–12m Americans suffer from chronic ulcers. The mortality rate for leg ulcers after the first amputation has dramatically doubled from 20% to 50% in the first three years to 70% after five years.
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