Healthcare Industry News: Treatment-Resistant Depression
News Release - October 1, 2008
Cyberonics Provides Update on Depression IndicationHOUSTON, Oct. 1 (HSMN NewsFeed) -- Cyberonics, Inc. (Nasdaq: CYBX ) today announced that it has completed a comprehensive process with respect to an effort to identify a partner for the depression indication related to the company's Vagus Nerve Stimulation (VNS) Therapy(TM) System.
Cyberonics announced in February a plan to identify a partner to assist with the activities required to obtain broad reimbursement coverage for the depression indication, including completion of the post-market studies mandated by the FDA in order to maintain approval of VNS Therapy(TM) for depression and the initiation of a new randomized clinical trial. The process undertaken over the last six months has not resulted in the receipt of an offer that provides sufficient value to the company's shareholders. Accordingly, Cyberonics is evaluating alternative actions intended to maintain the current regulatory approval, while minimizing the company's required investment, as well as ensuring that this valuable treatment continues to be available to patients in the United States and certain international markets.
"As we review alternatives, we remain committed to supporting patients and clinical partners while continuing to drive shareholder value," commented Dan Moore, President and Chief Executive Officer. "We previously stated that Cyberonics would not undertake a new clinical trial without a partner, and that continues to be our position. For the second half of fiscal 2009, costs related to the two post-market depression clinical programs are expected to be in the range of $3.5 million to $4.0 million. These costs are consistent with our previously provided guidance. In fiscal 2010, these costs are not expected to exceed $4.0 million and are anticipated to be less than $2.0 million in 2011, as the FDA-mandated clinical programs conclude. We are currently generating revenue of approximately $3.0 million per annum from the depression indication. We expect to continue the momentum we have experienced within our epilepsy business and the financial progress we have achieved over the last 12 months."
About VNS Therapy(TM) and Cyberonics
Cyberonics, Inc. (NASDAQ: CYBX ) is a medical technology company with core expertise in neuromodulation. The company developed and markets the Vagus Nerve Stimulation (VNS) Therapy(TM) System, which is FDA-approved for the treatments of epilepsy and 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, Inc. and VNS Therapy(TM) 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 maintaining the current regulatory approval for depression, minimizing the company's investment in the depression indication, ensuring that VNS Therapy continues to be available to depression patients, costs related to the two post-market depression clinical programs in the range of $3.5 million to $4.0 million in fiscal 2009, not in excess of $4.0 million in fiscal 2010, less than $2.0 million in 2011, and continuing the momentum we have experienced within our epilepsy business and the financial progress we have achieved over the last 12 months. 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 (including the previously disclosed private litigation); uncertainties associated with stockholder litigation; 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 25, 2008.
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