OrCel under review
This article was originally published in The Gray Sheet
Executive Summary
Ortec is raising funds for a planned September initiation of pivotal trials to support a diabetic foot ulcer indication for the wound care product. Meanwhile, FDA has accepted for review a modular PMA submission seeking market go-ahead for use of the collagen sponge for venous stasis leg ulcer treatment. Ortec is in talks with potential marketing partners and expects to ink a deal in time for the leg ulcer approval (1"The Gray Sheet" Feb. 16, 2004, p. 11)...
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