FDA Requests Confirmatory Trial for Approval of OrCel PMA
The FDA recommended that a confirmatory trial is necessary for Ortec International's OrCel after reviewing clinical data that demonstrated clinical significance in both the intent-to-treat population (all patients treated in the trial) as well as those patients with ulcers for which use of OrCel is indicated (partial and full thickness ulcers extending into dermis but not into the fascia).
While the FDA indicated the clinical data showed promise for OrCel's ability to effectively treat venous ulcers, the agency said additional data was necessary to demonstrate reasonable assurance of safety and effectiveness of OrCel in patients with venous leg ulcers. The FDA believed the analysis of the patients for which OrCel is indicated was not prospectively defined and recommended an additional prospective clinical trial to confirm Ortec's findings. Ortec estimates that approximately 40 patients will be required in the study.
Ortec also intends to initiate a resolution process with the FDA. As part of this formal process with the FDA, Ortec expects to provide data that will be made available through public filings.