28 Jul 1999 Cyberonics, Inc has reported that the Unites States FDA has granted expedited review status for a future premarket approval application for the Cyberonics' NCP System for the treatment of major depressive episodes in patients with unipolar and bipolar depressive disorder.
Depression is one of the many indications covered by our vagus nerve stimulation method patents.
The preliminary safety and efficacy results from our 30 patient depression pilot study are quite encouraging. Over half of the 30 patients in the depression pilot have now completed the study. All thirty patients in the pilot have been implanted and are expected to complete the study in the next 60 days. Once the data on all thirty patients in the depression pilot has been analyzed, we will work with FDA to finalize the protocol. Once the final protocol has been approved by FDA, it will then take two to three years to complete the study and submit a PMA seeking FDA Approval of a depression indication.