HOUSTON, April 4, 2013 /PRNewswire/ -- Cyberonics, Inc. (NASDAQ: CYBX) today provided an update on its recent submission to the Centers for Medicare & Medicaid Services ("CMS") seeking reimbursement coverage for the treatment-resistant depression ("TRD") indication for the VNS Therapy® System.
As previously announced, the company submitted a request to CMS for reconsideration of coverage for VNS Therapy for TRD and expected to receive a formal acknowledgment from CMS accepting or rejecting its request by the end of March 2013. To date, the company has not received a formal response from CMS, but is engaged in an ongoing dialogue regarding the reconsideration request. At this time, the timing and ultimate outcome of the dialogue is uncertain.
"We believe the total body of evidence that began appearing in the scientific literature in 2000 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. "We look forward to continuing our discussion with CMS with the objective of securing this access, although there can be no assurance that the coverage objectives will be met."
About Cyberonics, Inc. and the VNS Therapy System
Cyberonics, Inc. is a medical technology company with core expertise in neuromodulation. The company developed 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 a surgically implanted medical device that delivers pulsed electrical signals to the vagus nerve. Cyberonics markets the VNS Therapy System in selected markets worldwide.
Additional information on Cyberonics and the VNS Therapy System is available at www.cyberonics.com.
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 the receipt of a formal acknowledgment from CMS accepting or rejecting the company's reconsideration request, obtaining a reversal of CMS's national non-coverage decision for reimbursement of the VNS Therapy System for TRD, and obtaining CMS approval for reimbursement coverage for the VNS Therapy System for TRD. 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.
Greg Browne, CFO Cyberonics, Inc. 100 Cyberonics Blvd. Houston, TX 77058 Main: (281) 228-7262 Fax: (281) 218-9332 email@example.com
SOURCE Cyberonics, Inc.