Local company receives premarket clearance on wound care product

The Omeza Collagen Matrix is the company's first medical prescription product.

By Business Observer Staff
| 10:07 a.m. September 13, 2021
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Courtesy. Pictured is Omeza Founder and CEO Tom Gardner.

Manatee-Sarasota

SARASOTA — Omeza, a Sarasota-based skin science company, announced that its Omeza Collagen Matrix (OCM) product was cleared through the FDA 510(k) premarket notification process.

The product is Omeza’s first medical prescription product.

“No one has taken on the challenge of making advanced wound care products both effective and affordable, as a result preventable amputations are on the rise,” says Sarah Kitlowski, Omeza president, in a press release. “We are determined to bridge that gap. 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 a wound care matrix composed of hydrolyzed fish collagen infused with cod liver oil, which acts as an anhydrous skin protectant, and other plant-derived oils and waxes. According to the release, the matrix is naturally incorporated into the wound over time when it's been applied to a wound surface. The product comes in unit dose vials.

Courtesy. The Omeza Collagen Matrix (OCM) product received FDA clearance for the 510(k) premarket notification process. The matrix is Omeza’s first medical prescription product.

Omeza designed the wound care product for:

Partial and full-thickness wounds
Pressure ulcers
Venous ulcers
Diabetic ulcers
Chronic vascular ulcers
Tunneled/undermined wounds
Surgical wounds
Trauma wounds
Draining wounds

In December 2020, First Coast Cardio in Jacksonville became the first Florida clinical trial site for the investigation of the Omeza Treatment Bundle.

Earlier this year, the company closed on the sale of $5 million of convertible notes to 22 current and six new investors. With the sale, the skin health company’s total investment totaled $13 million, all of it from individuals. The company's goal is to raise $20 million for the Series A capital raise. The Series A round likely will be the company’s first institutional round of funding, according to a statement.

Omeza is a skin health and tissue regeneration company dedicated to equitable access to better wound care outcomes for all patients at all sites of care, reducing the rate of non-traumatic lower extremity amputations, hospitalizations due to skin infections and recurrence of chronic leg and foot wounds.