US FDA clears Integra LifeSciences’ Omnigraft dermal regeneration matrix

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Integra LifeSciences logoIntegra LifeSciences has received approval from the US Food and Drug Administration (FDA) for the packaging of its new product, Integra Omnigraft Dermal Regeneration Matrix.

The product’s packaging is designed for ease of handling and application in the outpatient wound care setting.

Integra’s Foot Ulcer New Dermal Replacement (FOUNDER) study on Omnigraft is the largest published diabetic foot ulcer study to date evaluating a cellular and/or tissue based product (CTP), and demonstrated significantly improved healing compared to conventional therapy, with a median of one application.
According to a company release, Omnigraft may reduce the financial burden for patients and the overall healthcare system, requiring only one application. Over 124 million people are covered in the USA for treatment by Omnigraft, through both private insurance and Medicare. Currently, 93% of Medicare patients, in 47 states, have access.