Therapy Areas: Devices
Omeza Receives FDA Clearance for Omeza Collagen Matrix
3 September 2021 - - The US Food and Drug Administration cleared Omeza Collagen Matrix through the FDA 510(k) premarket notification process, US-based skin science company Omeza said.

Omeza Collagen Matrix is Omeza's first Rx 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. 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.

In the United States, chronic ulcers are conservatively estimated to cost health care systems USD28 bn each year as a primary diagnosis and USD 31.7bn as a secondary diagnosis.

According to the American Diabetes Association, 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 3 years to 70% after five years.

Omeza is a skin science company dedicated to equitable access to better wound care outcomes for patients at all sites of care. The company is based in Sarasota, FL USA.
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