Press release from PR Newswire
Cyberonics Announces Hold on Shipment and Retrieval of Inventory of AspireHC? and AspireSR? Generators
Monday, August 15, 2011
Cyberonics Announces Hold on Shipment and Retrieval of Inventory of AspireHC? and AspireSR? Generators08:00 EDT Monday, August 15, 2011COMPANY AFFIRMS FINANCIAL GUIDANCE FOR FISCAL 2012HOUSTON, Aug. 15, 2011 /PRNewswire/ -- Cyberonics, Inc. (NASDAQ:CYBX), a global leader in devices for epilepsy management, announced today that it has voluntarily stopped shipment and is retrieving field inventory of its Aspire platform generators, Models 105 and 106. The company does not believe that the generators pose a health risk to patients, but initiated this action when it discovered that stimulation output current delivered to patients can be less than the output current programmed by a physician. Instructions will be provided to physicians regarding management of the approximately 118 patients worldwide who have been implanted with an AspireHC or AspireSR generator. Cyberonics has also suspended enrollment in its E-36 clinical trial pending resolution of this hardware-related design issue."Patient safety is our first priority. We are working expeditiously to resolve this problem. Our product development team has identified what we believe to be the cause of the problem, as well as several potential hardware solutions," said Dan Moore, President and Chief Executive Officer. "Our goal is to implement and validate a solution and submit for regulatory approvals by no later than the end of the fiscal year."The company, which completed the first quarter of fiscal 2012 on July 29, 2011 and will report financial results on August 25, 2011, does not currently anticipate a change to guidance for fiscal year 2012 as a result of this action. The previously provided guidance remains at $212 million to $215 million for net sales, and $54 million to $57 million for income from operations. Sales for the AspireHC (Model 105) generator comprised approximately 9% of worldwide revenue in the recently completed first quarter, and the company believes that the availability of alternate models provides physicians and patients with appropriate additional options for the treatment of refractory epilepsy.About Cyberonics, Inc. and the VNS Therapy® SystemCyberonics, 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 statementThis 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 health risks to patients as a result of this matter, resolution of the hardware-related design issue expeditiously, identification of the cause of the problem and potential hardware solutions, submission of the revised AspireHC device for regulatory approvals by the end of the fiscal year, confirmation of previous guidance for net sales and income from operations, and the use of alternative generator models by physicians and patients to replace sales of the AspireHC generator. 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 products; 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 patent infringement claims; potential litigation relating to compliance with laws and regulations pertaining to our business; 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. Contact InformationGreg Browne, CFOCyberonics, Inc.100 Cyberonics Blvd.Houston, TX 77058Main: (281) 228-7262Fax: (281) firstname.lastname@example.orgSOURCE Cyberonics, Inc.