Leg Ulcers

Premarket approval application to be filed for venous leg ulcer treatment

Published in Obesity and Diabetes Week, January 19th, 2004

Ortec International, Inc., (ORTN) has initiated the filing of its Premarket Approval (PMA) application requesting permission from the U.S. Food and Drug Administration (FDA) to market its tissue engineered product, OrCel, for the treatment of venous leg ulcers, an estimated $500 million market in the U.S.

Ortec submitted the Manufacturing and Controls (CMC) section, the first of two modules of the application. The final section of the PMA, which will include a summary of safety and effectiveness in the clinical studies and device labeling, is expected to be filed with the FDA at the end of January 2004.

Ortec recently announced that in agreement with...

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Source: Obesity and Diabetes Week (2004-01-19)

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