Cyberonics Announces FDA Approval of Re-Designed AspireHC™ Generator for VNS Therapy
HOUSTON, Jan. 3, 2012 /PRNewswire/ -- Cyberonics, Inc. (NASDAQ: CYBX) today announced that the United States Food and Drug Administration (FDA) has approved its re-designed AspireHC (High Capacity) generator, which was the subject of a voluntary product withdrawal in August 2011.
"We are pleased that the FDA was able to complete its review in approximately 60 days, enabling us to resume our limited commercial release of the AspireHC generator in the United States," said Dan Moore, Cyberonics' President and Chief Executive Officer. "With the CE Mark approval announced in December and a recently obtained Canadian approval, we will also resume the limited commercial release in Europe and initiate a limited commercial release in Canada. The AspireHC generator addresses a need among some patients for a device with a higher capacity battery and also provides a platform for the AspireSR™ seizure response generator, which is the subject of our E-36 clinical trial in Europe. We anticipate submission of the re-designed AspireSR generator for ethics committee and competent authority approvals for the E-36 clinical trial no later than the end of our fiscal year in April 2012."
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 making filings to support the resumption of the AspireSR™ generator E-36 European clinical trial by the end of the fiscal year and resumption of the E-36 clinical trial. 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 other indications; satisfactory completion of post-market studies 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 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 29, 2011, and our Quarterly Report on Form 10-Q for the fiscal quarters ended July 29, 2011 and October 28, 2011.
Greg Browne, CFO
100 Cyberonics Blvd.
Houston, TX 77058
Main: (281) 228-7262
Fax: (281) 218-9332
SOURCE Cyberonics, Inc.