The follow-up inspection requested by CDRH will begin on Monday, June 6, 2005. "We believe that the follow-up inspection will quickly confirm the Dallas District Office's findings that led to the official closure of the Warning Letter, and will confirm that Cyberonics has implemented all the corrective and preventive actions anticipated by our Warning Letter response and documented in the two status reports already provided to the Dallas District Office," commented Robert P. ("Skip") Cummins, Cyberonics' Chairman of the Board and Chief Executive Officer.
The four manuscripts from the TRD pilot and pivotal studies accepted for publication in prestigious peer-reviewed psychiatry journals cover the D-02 pivotal study acute results, the D-02 pivotal study one-year longitudinal results, the D-02 pivotal study one-year outcomes compared to those from the D-04 active treatment-as-usual control group and the D-01 pilot study two-year results. The journals, the authors and actual publications will be disclosed at the time of actual publication. "Peer-reviewed journal publications of the most important results from the VNS TRD studies that are also presented in the labeling will accelerate VNS awareness and acceptance by psychiatrists, patients, families and payers," added Mr. Cummins.
"Cyberonics is looking forward to improving the lives of Americans touched by TRD with the same VNS Therapy that will very soon reach 100,000 patient years of U.S. epilepsy commercial experience," concluded Mr. Cummins. "We believe that Cyberonics will have that opportunity once minor labeling changes requested by CDRH are made and the follow-up inspection requested by CDRH has been satisfactorily completed. In the meantime, Cyberonics' 300-plus demand creation and customer support personnel will hone their skills by creating awareness, acceptance and demand for VNS Therapy among neurologists, surgeons, hospitals, payers and patients in epilepsy."
ABOUT VNS THERAPY AND CYBERONICS
Cyberonics, Inc. (Nasdaq: CYBX) was founded in 1987 to design, develop and
market medical devices for the long-term treatment of epilepsy, depression and
other chronic neurological disorders using a unique therapy, vagus nerve
stimulation (VNS). Stimulation is delivered by the VNS Therapy System, an
implantable generator similar to a cardiac pacemaker. The VNS Therapy System
delivers preprogrammed intermittent mild electrical pulses to the vagus nerve
in the patient's neck 24 hours a day. The Company's initial market is
epilepsy, a disorder characterized by recurrent seizures. Epilepsy is the
second most prevalent neurological disorder. The Cyberonics VNS Therapy
System was approved by the FDA on July 16, 1997 for use as an adjunctive
therapy in reducing the frequency of seizures in adults and adolescents over
12 years of age with partial onset seizures that are refractory to
antiepileptic medications. The VNS Therapy System is also approved for sale
as a treatment for epilepsy in all the member countries of the European
Economic Area, Canada, Australia and other markets. To date, more than 31,000
epilepsy patients in 24 countries have accumulated over 94,000 patient years
of experience using VNS Therapy. The VNS Therapy System was deemed approvable
in writing by the FDA on February 2, 2005 as an adjunctive treatment for
chronic treatment-resistant depression for adults over the age of 18.
According to FDA's approvable letter, final approval was conditional on final
labeling, final protocols for a post-approval dosing optimization study and
patient registry, satisfactory compliance with the Quality System Regulations
(QSR) and satisfactory resolution of any outstanding bioresearch monitoring
issues. The VNS Therapy System is approved for sale in the European Economic
Area and in Canada as a treatment for depression in patients with treatment-
resistant or treatment-intolerant major depressive episodes, including
unipolar depression and bipolar disorder (manic depression). VNS Therapy is
at various levels of investigational clinical study as a potential treatment
for anxiety disorders, Alzheimer's disease, chronic headache/migraine and
bulimia. The Company is headquartered in Houston, Texas and has an office in
Brussels, Belgium. For additional information please visit us at
http://www.cyberonics.com .