HOUSTON, May 28, 2013 /PRNewswire/ -- Cyberonics, Inc. (NASDAQ: CYBX) today announced the receipt of a letter from the Centers of Medicare and Medicaid Services (CMS) declining the company's request to reconsider the 2007 National Coverage Determination for the treatment-resistant depression indication.
"Cyberonics is very disappointed in the position taken by CMS that the new evidence accumulated over the past five years and recently published in four peer-reviewed journals does not support reconsideration of the non-coverage decision. We believe the total body of evidence that began appearing in the scientific literature in 1998 presents compelling rationale for access to VNS Therapy in a very ill subpopulation of Medicare beneficiaries," said Dan Moore, Cyberonics' President and Chief Executive Officer. "The company plans to work with other interested parties to continue to pursue access to this important therapeutic option for patients who could benefit from VNS Therapy, including carefully evaluating all options for appealing this decision."
The company will provide additional information at its previously-announced financial results conference call on June 5, 2013.
About Cyberonics, Inc. and the VNS Therapy SystemCyberonics, Inc. is a medical technology company with core expertise in neuromodulation. The company develops and markets the VNS Therapy system, which is FDA-approved for the treatment of refractory epilepsy and treatment-resistant depression. The VNS Therapy system uses an implanted medical device that delivers pulsed electrical signals to the vagus nerve. Cyberonics markets the VNS Therapy system in selected markets worldwide. Safe harbor statement 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," "forecast," or other similar words. Statements contained in this press release are based on information presently available to us and assumptions that we believe to be reasonable. We are not assuming any duty to update this information if those facts change or if we no longer believe the assumptions to be reasonable. Investors are cautioned that all such statements involve risks and uncertainties, including without limitation, statements concerning appealing CMS's decision not to reconsider the 2007 NCD and obtaining a positive coverage determination from CMS for VNS Therapy in patients with treatment-resistant depression. 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 products; the development and satisfactory completion of clinical trials and/or market test and/or regulatory approval of new products, including VNS Therapy for the treatment of other indications; satisfactory completion of the post-market registry required by the U.S. Food and Drug Administration as a condition of approval for the treatment-resistant depression indication; 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 products and indications; 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; the potential identification of material weaknesses in our internal controls over financial reporting; and other risks detailed from time to time in our filings with the Securities and Exchange Commission (SEC). For a detailed discussion of these and other cautionary statements, please refer to our most recent filings with the SEC, including our Annual Report on Form 10-K for the fiscal year ended April 27, 2012 and our Quarterly Report on Form 10-Q for fiscal quarters ended July 27, 2012, October 26, 2012 and January 25, 2013. Additional information about Cyberonics and the VNS Therapy system is available at www.cyberonics.com. Contact Information Greg Browne, CFOCyberonics, Inc.100 Cyberonics Blvd. Houston, TX 77058Main: (281) 228-7262 Fax: (281) 218-9332 firstname.lastname@example.org
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