Ortec OrCel
This article was originally published in The Gray Sheet
Executive Summary
Firm expects to complete filing of a PMA for the cryopreserved tissue product to treat venous leg ulcers by the end of January. The application is based on a 135-patient randomized trial comparing OrCel to standard compression therapy. Results of the trial, released Dec. 9, show that 12 weeks after application 59% of patients in the OrCel group achieved 100% closure compared to 36% of the control group - a 64% improvement. The average time to healing with OrCel was 57 days. Following completion of the PMA filing, Ortec plans to begin a pivotal trial to support a diabetic foot ulcer indication (1"The Gray Sheet" Aug. 5, 2002, p. 14)...