Cyberonics' VNS Therapy(TM) System Receives Regulatory Approval in Japan
20 January 2010 - 1:00AM
PR Newswire (US)
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(TM) 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(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 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," "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(TM) and sales of our product; the development and
satisfactory completion of clinical trials and/or market test
and/or regulatory approval of VNS Therapy(TM) 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. Contact Information: -------------------- Greg Browne, CFO
Cyberonics, Inc. 100 Cyberonics Blvd. Houston, TX 77058 Main: (281)
228-7262 Fax: (281) 218-9332 DATASOURCE: Cyberonics, Inc. CONTACT:
Greg Browne, CFO of Cyberonics, Inc., +1-281-228-7262, fax,
+1-281-218-9332, Web Site: http://www.cyberonics.com/
http://www.vnstherapy.com/
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