Cyberonics Announces Exclusive Distribution Agreement With Nihon Kohden in Japan
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HOUSTON, June 1 /PRNewswire-FirstCall/ -- Cyberonics, Inc. (Nasdaq: CYBX)
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. (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 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 information
Greg Browne, CFO
Cyberonics, Inc.
100 Cyberonics Blvd.
Houston, TX 77058
Main: (281) 228-7262
Fax: (281) 218-9332
ir@cyberonics.com
SOURCE Cyberonics, Inc.
Greg Browne, CFO of Cyberonics, Inc., +1-281-228-7262, fax, +1-281-218-9332,
ir@cyberonics.com
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