HOUSTON, Jan. 19 /PRNewswire-FirstCall/ -- Cyberonics, Inc. (Nasdaq: CYBX) today announced that the Japanese Ministry of Health, Labor and Welfare (MHLW) has granted the company final regulatory approval to market and sell its VNS Therapy™ System for the epilepsy indication.
"Japan is one of the largest medical device markets in the world, and we are pleased to have the opportunity to serve this important country," said Dan Moore, Cyberonics' President and Chief Executive Officer. "Our clinically proven VNS Therapy System, which to date has been implanted in more than 55,000 patients worldwide, will provide a unique treatment option for Japanese patients who suffer from refractory epilepsy. We are grateful for the valuable support and expertise provided by our Japanese distribution partner, Nihon Kohden Corp., in securing this approval."
The company plans to launch its VNS Therapy System in Japan following final reimbursement authorization.
"We are very pleased to be able to provide a new therapy option to those who suffer from refractory epilepsy in Japan," said Fumio Suzuki, President, Chief Operating Officer of Nihon Kohden. "The regulatory approval in Japan for the VNS Therapy System covers all people with drug-resistant refractory epilepsy, except the cases for which surgery is recommended, but without restrictions as to age or type of epilepsy. Together with our EEG monitoring systems, we are now in a position to better serve medical professionals who fight this difficult-to-manage neurological disease in Japan," Mr. Suzuki added.
About Cyberonics, Inc. and VNS Therapy™
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™ System, which is FDA-approved for the treatments 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.
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 obtaining reimbursement authorization and commercial launch of the VNS Therapy System for epilepsy in Japan. 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 24, 2009 and Quarterly Reports on Form 10-Q for the fiscal quarters ended July 24, 2009 and October 23, 2009.
Greg Browne, CFO
100 Cyberonics Blvd.
Houston, TX 77058
Main: (281) 228-7262
Fax: (281) 218-9332
SOURCE Cyberonics, Inc.