Cyberonics Announces FDA Approval of Aspire High Capacity Generator for VNS Therapy
HOUSTON, Feb. 1, 2011 /PRNewswire/ -- Cyberonics, Inc. (Nasdaq: CYBX) today announced that the AspireHC™ (High Capacity) generator for use in vagus nerve stimulation (VNS) therapy was approved by the United States Food and Drug Administration (FDA) for commercial release.
The AspireHC generator (development name NXT HC) represents the fifth generation of VNS Therapy® technology. This product incorporates greater functionality for the benefit of patients and their physicians, including longer battery life, improved electronics and simplified features for programming.
The AspireHC generator is expected to be in limited commercial release in the United States in the Company's current quarter ending April 29, 2011. The company has applied for the CE Mark.
"The AspireHC generator will enhance the quality of life for VNS patients, and we are gratified that the FDA completed their review in an expeditious manner," said Dan Moore, Cyberonics' President and Chief Executive Officer. "In addition, this generator provides an important platform for future new product introductions, including the AspireSR seizure response system for which a European clinical trial is planned to start in the first half of calendar 2011."
To date, more than 60,000 patients worldwide have been implanted with the VNS Therapy System for epilepsy.
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 electrical pulsed 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 limited commercial release of the AspireHC generator in the U.S. in the Company's current quarter ending April 29, 2011 and the start of a European clinical trial in the first half of calendar year 2011. 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 results of the previously disclosed governmental inquiries; the potential identification of material weaknesses in our internal controls over financial reporting; risks and costs associated with such governmental inquiries and any litigation relating thereto or to our stock option grants, procedures, and practices 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 30, 2010, and Quarterly Reports on Form 10-Q for the fiscal quarters ended July 30, 2010 and October 29, 2010.
Greg Browne, CFO
100 Cyberonics Blvd.
Houston, TX 77058
Main: (281) 228-7262
Fax: (281) 218-9332
SOURCE Cyberonics, Inc.