HOUSTON, June 1 /PRNewswire-FirstCall/ -- Cyberonics, Inc. today announced the signing of an exclusive agreement with Nihon Kohden Corporation for the distribution of VNS Therapy Systems for epilepsy patients in Japan. The companies are working together to obtain the necessary regulatory and reimbursement approvals.
“We are very excited to partner with Nihon Kohden to make VNS Therapy available to Japanese patients who suffer from refractory epilepsy,” commented Dan Moore, Cyberonics’ President and Chief Executive Officer. “Nihon Kohden is a premier manufacturer and distributor of medical devices in Japan with extensive, long-term experience in neurology. Nihon Kohden is our representative to the Japanese Ministry of Health, Labour and Welfare, and this agreement represents an important milestone toward our goal to bring VNS Therapy to one of the largest medical device markets in the world.”
“The VNS Therapy System is a perfect addition to our product line for the neurology area,” said Fumio Suzuki, President and COO of Nihon Kohden. “Along with our long-term EEG monitoring systems for diagnosis of epilepsy, our goal is to make VNS Therapy Systems a standard of care for refractory epilepsy in Japan.”
About Cyberonics, Inc. and VNS Therapy(TM)
Cyberonics, Inc. 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 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.
Additional information on Cyberonics, Inc. and VNS Therapy(TM) is available at www.cyberonics.com and www.vnstherapy.com.
About Nihon Kohden
Nihon Kohden is Japan’s leading manufacturer, developer and distributor of patient monitors, defibrillators, ECGs, EEGs, EP/EMGs, hematology analyzers and other medical electronic equipment, with subsidiaries in the United States, Europe, and Asia, and distributors in nearly every country in the world. Nihon Kohden is a publicly held company listed in the First Section of the Tokyo Stock Exchange. In addition to designing medical equipment for hospital and clinic use, Nihon Kohden actively contributes to the advance of medical technology.
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 approval for the marketing of VNS Therapy for epilepsy in Japan and making VNS Therapy Systems a standard of care 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 (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 and our Quarterly Reports of Form 10-Q for the fiscal quarters ended July 25, 2008 and October 24, 2008.
CONTACT: Greg Browne, CFO of Cyberonics, Inc., +1-281-228-7262, fax,
+1-281-218-9332, ir@cyberonics.com
Web site: http://www.cyberonics.com/
