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AMA CPT Editorial Panel Approves Use of Cyberonics' VNS Therapy(TM) System Programming Codes for Treatment-Resistant Depression

Posted on: Thursday, 8 September 2005, 09:01 CDT

HOUSTON, Sept. 8 /PRNewswire-FirstCall/ -- Cyberonics, Inc. today announced that it was recently notified by the American Medical Association (AMA) that its CPT Editorial Panel has approved a parenthetical cross reference in the CPT Coding Manual directing physicians to codes 95970, 95974 and 95975 for analysis/programming of neurostimulators, including Cyberonics' VNS Therapy System, for the treatment of treatment-resistant depression (TRD). The parenthetic will appear in the Other Psychiatric Services or Procedures section.

According to the AMA, the clarification of the use of the neurostimulator programming codes to include TRD will be included in the September 2005 issue (Volume 15, Issue 9) of AMA's CPT Assistant and will appear in the 2007 Edition of the CPT Coding Manual. CPT Assistant, a monthly AMA newsletter, is an official tool for accurate information on CPT Codes, Issues and Guidance. CPT Assistant provides timely information on day-to-day coding questions among other resources. In addition to the CPT Editorial Panel notification, the American Psychiatric Association (APA) through the publication Psychiatric News has communicated this coding clarification to all members of APA (http://pn.psychiatryonline.org/cgi/content/full/40/17/23-a ).

"Psychiatrists treating TRD patients with VNS Therapy are now permitted to use the same programming codes for their VNS Therapy System programming services as those used by neurologists for the treatment of patients with pharmaco-resistant epilepsy," commented Robert P. ("Skip") Cummins, Cyberonics' Chairman of the Board and Chief Executive Officer. "The AMA CPT Editorial Panel's favorable coding decision represents a major step forward towards Cyberonics' objective of providing all our TRD customers with the same favorable VNS coverage, coding and reimbursement as exists today in epilepsy. Essentially all the codes related to all VNS Therapy services and procedures in TRD are now in place approximately one month after TRD approval, considerably more quickly relative to approval as was the case in epilepsy. Codes that adequately described surgeons' VNS implant services and neurologists' programming services in epilepsy were not clarified until some 42 months and some 30 months, respectively, following epilepsy approval in July 1997.

"As expected, our remaining challenge in providing TRD patients with universal access to VNS is coverage," continued Mr. Cummins. "We continue to make steady progress in obtaining not only case-by-case prior authorizations, but also favorable regional and national coverage policies across public and private payers. The body of scientific evidence supporting the use and coverage of VNS Therapy in treatment-resistant depression continues to build and now includes not only the product's fully-informative labeling and FDA's Summary of Safety and Effectiveness, but also the recent publication in Biological Psychiatry of the first three manuscripts from the TRD pivotal studies. We expect a number of equally important peer-reviewed journal articles to be published in the months ahead. In summary, Cyberonics remains confident that a greater percentage of patients with TRD will have access to VNS Therapy in the first year following launch on August 1, 2005 than was the case in the first year after epilepsy approval on July 16, 1997."

ABOUT DEPRESSION AND TREATMENT-RESISTANT DEPRESSION

Major Depressive Disorder (MDD) is one of the most prevalent and serious illnesses in the United States, affecting nearly 19 million Americans over the age of 18 in any given year. According to the National Institute of Mental Health, depression is the leading cause of disability in the United States and worldwide. Depression interferes with one's ability to function, feel pleasure or maintain interest in everyday living. MDD is associated with increased mortality due to suicide and comorbid general medical conditions including heart disease and stroke. Depressed patients use twice the healthcare services as non-depressed patients. Total annual costs of depression in the U.S. exceed $80 billion including $30 billion in annual direct treatment costs. A person with depression is 35 times more likely to commit suicide than a person not experiencing depression and 15 percent of previously hospitalized depressed patients commit suicide.

Most psychiatrists define treatment-resistant depression (TRD) as a major depressive episode that has not had an adequate response to two or more adequate antidepressant treatments at appropriate dose and duration. Twenty percent of those with depression or approximately four million people suffer from TRD. For these patients, treatments including psychotherapy, antidepressant medications and electroconvulsive therapy do not work. Studies show that annual healthcare costs for patients with TRD exceed $40,000 per patient per year, approximately six times the cost of those without TRD.

ABOUT VNS THERAPY AND CYBERONICS

Cyberonics, Inc. was founded in 1987 to design, develop and market medical devices for the long-term treatment of epilepsy, depression and other chronic treatment-resistant disorders using a unique therapy, vagus nerve stimulation (VNS). Stimulation is delivered by the VNS Therapy System(TM), 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 was 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 European Economic Area, Canada, Australia and other markets. To date, more than 32,000 epilepsy patients in 24 countries have accumulated over 100,000 patient years of experience using VNS Therapy.

The VNS Therapy System was approved by the FDA on July 15, 2005 "as an adjunctive long-term treatment for chronic or recurrent depression for patients 18 years of age and older who are experiencing a major depressive episode and have not had an adequate response to four or more adequate antidepressant treatments." As part of FDA's approval order, Cyberonics is required to conduct a 450-patient post-market dosing study and a 1,000- patient, five-year patient outcome registry. For more information on VNS Therapy for treatment-resistant depression, including the contraindications, warnings and precautions, see the Physician's and Patient's Manuals and other information at http://www.cyberonics.com/ or http://www.vnstherapy.com/ or call 1-877-NOW 4 VNS.

The VNS Therapy System has been 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) since 2001.

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/ .

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. These statements can be identified by the use of forward-looking terminology, including "may,""believe,""will,""expect,""anticipate,""estimate,""plan,""intend," and "forecast," or other similar words. Such forward-looking statements include statements concerning future publication of important peer-reviewed journal articles related to VNS Therapy for treatment-resistant depression and providing access to VNS Therapy for a greater percentage of patients with TRD in the first year following launch on August 1, 2005 than was the case in the first year after epilepsy approval on July 16, 1997. Statements contained in this press release are based upon information presently available to us and assumptions that we believe to be reasonable. We are not assuming any duty to update this information should those facts change or should we no longer believe the assumptions to be reasonable. Our actual results may differ materially. Important factors that may cause actual results to differ include, but are not limited to: continued market acceptance of VNS Therapy and sales of our product; the development and satisfactory completion of clinical trials and/or market test and/or regulatory approval of VNS Therapy for the treatment of Alzheimer's disease, anxiety, or other indications; adverse changes in coverage or reimbursement amounts by third-parties; intellectual property protection and potential infringement claims; maintaining compliance with government regulations and obtaining necessary government approvals for new applications; product liability claims and potential litigation; reliance on single suppliers and manufacturers for certain components; the accuracy of management's estimates of future expenses and sales; and other risks detailed from time to time in the Company's filings with the SEC.

Cyberonics, Inc.

CONTACT: Pamela B. Westbrook, Vice President of Finance and CFO ofCyberonics, Inc., +1-281-228-7200, or fax, +1-281-218-9332, orpbw@cyberonics.com ; or Helen Shik, Vice President of Schwartz Communications,+1-781-684-0770, or fax, +1-781-684-6500, or hshik@schwartz-pr.com , forCyberonics, Inc.

Web site: http://www.cyberonics.com/http://www.vnstherapy.com/http://pn.psychiatryonline.org/cgi/content/full/40/17/23-a

Source: PRNewswire-FirstCall

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