HOUSTON, Nov. 4 /PRNewswire-FirstCall/ -- Cyberonics, Inc. today announced that 2005 Medicare outpatient reimbursement rates for Cyberonics’ VNS Therapy System have been posted on the CMS website (http://www.cms.hhs.gov/medlearn/refopps.asp ) and published in the Federal Register. Beginning January 2005, average Medicare reimbursement to hospitals for outpatient implantation of the VNS Therapy System increases 2% to $24,645 for the implantation and intra-operative programming of the VNS Therapy Systems as follows: $12,532 under APC 0039 for implantation of neurostimulator, $11,996 under APC 0225 for implantation of neurostimulator electrodes, and $117 under APC 0692 for the intra-operative electrode test. In 2005, APC 0039 will apply for both the original implantation and the replacement of the VNS generator.
“Cyberonics is very pleased with Medicare’s decision not only to once again increase hospital reimbursement for implantation of the VNS Therapy System, but also to reimburse the same amount for generator replacements as is reimbursed for new patient generator implants,” commented Robert P. (“Skip”) Cummins, Cyberonics’ Chairman and Chief Executive Officer. “Cyberonics has worked diligently to make VNS Therapy safe, effective and cost-effective for all our customers including payers. This important decision confirms our progress towards that objective and lays the foundation for adequate reimbursement of future generations of the VNS Therapy System and future FDA- approved indications.”
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 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 24 hours a day. The Company’s initial market is epilepsy, which is 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 27,000 epilepsy patients in 24 countries have accumulated over 79,000 patient years of experience using VNS Therapy. 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 depression, anxiety disorders, Alzheimer’s disease, and chronic headache/migraine. 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 obtaining regulatory approvals and adequate reimbursement for VNS Therapy and related procedures. 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 depression, 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 in 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, ext. 6587, or fax, +1-781-684-6500, orhshik@schwartz-pr.com , for Cyberonics, Inc.