FDA: Omeza's Collagen Matrix Cleared for Marketing

Omeza Collagen Matrix 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 U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to the Omeza Collagen Matrix for chronic wound care.

Omeza Collagen Matrix (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. When applied to a wound surface, the matrix is naturally incorporated into the wound over time. Omeza Collagen Matrix 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 easy to use, unit dose vials.

Omeza Collagen Matrix is indicated 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-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, superficial partial thickness burns, skin tears) and draining wounds.

"No one is taking on the challenge of making advanced wound care products both effective and affordable, yet preventable amputations are on the rise. We are determined to bridge that gap," says Sarah Kitlowski, President of Omeza, in a news release. "Our mission is to give practitioners groundbreaking new tools to help protect and manage the wound during the natural processes of wound closure."