FDA Clears Drug-Device Combination Matrix for Chronic Wound Care

The US Food and Drug Administration (FDA) has cleared the Omeza Collagen Matrix, a drug-device combination matrix for chronic wound care.

The approval was granted through the FDA 510(k) premarket notification process. It is the first combination drug/device designed for chronic wound care.

Product

The wound care matrix is composed of hydrolyzed fish collagen infused with cod liver oil and other plant-derived oil and wax. After it is applied to a wound, the matrix is incorporated into the wound over time.

Its design is based for intimate contact with regular and irregular wound beds to aid in the natural wound healing process. The product is a no-prep application accessible in unit dose vials.

Research shows the indications for the management of wounds included partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, and chronic vascular ulcers.

In addition, it is indicated for tunneled/undermined wounds, surgical wounds, including donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence, trauma wounds including abrasions, lacerations, superficial partial thickness burns, skin tears, and draining wounds.

Reaction

Sarah Kitlowski, president, Omeza, explained in a statement the company's mission is to build new tools to both help protect and manage wounds during the natural processes of wound closure.

"No one is taking on the challenge of making advanced wound care products both effective and affordable, yet preventable amputations are on the rise," Kitlowski said. "We are determined to bridge that gap."