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Omeza Receives FDA Clearance for Omeza Collagen Matrix

When applied to a wound surface, the matrix is naturally incorporated into the wound over time.

By Staff September 8, 2021

Omeza's products include its collagen matrix, far right.

Omeza's products include its collagen matrix, far right.

Omeza, the Sarasota-based skin science company, recently announced that the U.S. Food and Drug Administration (FDA) has cleared its Omeza Collagen Matrix through the FDA's 510(k) premarket notification process. Omeza Collagen Matrix is Omeza’s first prescription product, and the first drug/device combination matrix of its kind for chronic wound care.

Omeza Collagen Matrix 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. When applied to a wound surface, the matrix is naturally incorporated into the wound over time. It is designed for intimate contact with both regular and irregular wound beds to provide a conducive environment for the patient’s natural wound healing process. The product features a no-prep application supplied in unit-dose vials. It is intended for the management of wounds including partial- and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, superficial partial thickness burns, skin tears) and draining wounds.

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