Healthcare Industry News: VNS Therapy
News Release - July 18, 2006
Cyberonics Receives FDA Real-Time Review Approval for New VNS Therapy Perennia LeadHOUSTON, July 18 (HSMN NewsFeed) -- Cyberonics, Inc. (Nasdaq: CYBX ) today announced that it received FDA Real-Time Review approval for its new VNS Therapy(TM) Perennia(TM) Lead. The Perennia Lead, which is connected to the VNS Therapy System Generator and attached to the left vagus nerve, can be used with the current Model 102 and the future Demipulse(TM) Pulse Generators (Models 103 and 104). The new lead will perform the same function as its predecessor, but incorporates a new design constructed from more durable components. In mechanical tests conducted in the laboratory, the Perennia Lead proved to be more robust and reliable than its predecessor, the highly reliable Model 302 Lead. The Perennia Lead is expected to be available in the United States in late 2006 and will likely be priced higher than the current Model 302 Lead. Cyberonics also recently announced FDA approval of a new harmonized/modularized VNS Therapy System labeling format, and next generation VNS Therapy Software.
"The new VNS Therapy System Perrenia Lead is a result of Cyberonics' ongoing engineering initiatives to further enhance the VNS Therapy System and improve its reliability. Technologically better products help us accomplish more of our mission to improve the lives of people touched by chronic treatment-resistant illnesses," said Richard L. Rudolph, M.D., Cyberonics' Vice President, Clinical and Medical Affairs and Chief Medical Officer. "These latest FDA new product approvals clearly demonstrate not only Cyberonics' unwavering commitment to product innovation, but also its ability to meet the FDA's high standards for medical devices."
About VNS Therapy and Cyberonics
Information on Cyberonics, Inc. and VNS Therapy is available at http://www.cyberonics.com and http://www.VNSTherapy.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," and "forecast," or other similar words. 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. Investors are cautioned that all such statements involve risks and uncertainties, including without limitation, statements concerning the timing for market release of new products, including the Perennia(TM) Lead and the Demipulse(TM) Pulse Generator and the pricing for new products. 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 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; the time needed to complete the Audit Committee's review of stock option grants, procedures, and practices; the potential need to seek from NASDAQ an extension of time to file the Form 10-K to avoid possible delisting of the Company's stock from the NASDAQ National Market for failure to file timely periodic reports with the SEC; uncertainties associated with any hearing or appeal concerning any possible delisting by NASDAQ; the results of the governmental inquiries and Audit Committee's review; the impact of any restatement of the Company's financial statements or other actions that might be taken or required as a result of such inquiries or review; the potential identification of new material weaknesses in the Company's internal controls over financial reporting; risks and costs associated with such inquiries or review and any litigation relating thereto or to the Company's stock option grants, procedures, and practices. and other risks detailed from time to time in the Company's filings with the Securities and Exchange Commission (SEC). For a detailed discussion of these and other cautionary statements, please refer to Cyberonics' most recent filings with the SEC, including its Form 10-K for the fiscal year ended April 29, 2005.
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