FDA Clears Omeza Collagen Matrix

Omeza announced yesterday that the FDA has given 510(k) clearance for the Omeza Collagen Matrix for chronic wound care.

Omeza, a skin science company, announced that the FDA has granted clearance to Omeza Collagen Matrix (OCM), Omeza’s first Rx product, through the FDA 510(k) premarket notification process, according to their press release.

OCM is a wound care matrix that is made of hydrolyzed fish collagen infused with cod liver oil and other plant-derived oils and waxes. It is applied to the wound surface and is for both regular and irregular wounds to improve the healing process. The device makes application easy by being available in unit dose vials. 

"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," said Sarah Kitlowski, president of Omeza, Sarasota, Florida, in the press release. "Our mission is to give practitioners groundbreaking new tools to help protect and manage the wound during the natural processes of wound closure."

OCM is indicated for wound care management 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.

Reference:

1. Omeza receives FDA clearance for Omeza® collagen matrix. Published September 2, 2021. Accessed September 2, 2021. https://www.prnewswire.com/news-releases/omeza-receives-fda-clearance-for-omeza-collagen-matrix-301368632.html