Navigation Links
Cyberonics Provides Business Update on Depression Clinical Trial

HOUSTON, Jan. 7 /PRNewswire-FirstCall/ -- Cyberonics, Inc. (Nasdaq: CYBX) today announced that it has made a proposal to the U.S. Food and Drug Administration ("FDA") to amend the protocol of its post-market dosing study (D-21) in depression patients treated with VNS TherapyTM.

Based on a reassessment of the study power and size following the FDA's approval of an amendment to the data analysis originally specified in the study protocol, the company proposes to reduce the number of study subjects from 460 to 330, while still maintaining appropriate study power. The company expects to meet this revised enrollment level within one to two months and will thereafter suspend further patient enrollment pending FDA's decision on its proposed amendment, which was submitted in November 2008. The company expects to complete the follow-up on all patients enrolled in the study. At this time, the company does not know when to expect a decision from the FDA.

About Cyberonics, Inc. and VNS TherapyTM

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 and

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 reducing the number of study subjects in the D-21 clinical study and completing follow-up on patients enrolled in the D-21 clinical study. 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

SOURCE Cyberonics, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related biology technology :

1. Cyberonics Provides Update on Business Operations Following Hurricane Ike
2. Cyberonics Reports Strong Revenue Growth and Profitability in Fiscal 2008 Fourth Quarter
3. Vasogen Provides Corporate Update
4. Neurobiological Technologies Partner, Celtic Pharma, Provides Update on XERECEPT(R) Clinical Program and Planned Sale in 2009
5. Cornerstone Therapeutics Provides Update on Integration Activities and Issues 2008 Revenue Guidance
6. GeneNews provides Centocor access to its osteoarthritis program
7. ATS Medical Provides Update on US Commercialization of Its ATS 3f Aortic Bioprosthesis
9. New Report Provides Expert Analysis of Recent Advances and Setbacks in Parkinsons Disease Drug Development
10. provides Spa Enthusiasts Affordable Alternatives for Expensive Spa Treatments
11. New Radiation-Blocking Medical Garments Introduced at RSNA Meeting in Chicago : Demron-M Technology Provides Total Protection in a Lightweight, Durable, Flexible Fabric
Post Your Comments:
(Date:6/27/2016)... -- Global demand for enzymes is forecast to grow ... billion.  This market includes enzymes used in industrial ... animal feed, and other markets) and specialty applications ... beverages will remain the largest market for enzymes, ... containing enzymes in developing regions.  These and other ...
(Date:6/27/2016)... , ... June 27, 2016 , ... Parallel 6 ... trials, announced today the Clinical Reach Virtual Patient Encounter CONSULT module which ... with the physician and clinical trial team. , Using the CONSULT module, patients and ...
(Date:6/27/2016)... , June 27, 2016   Ginkgo Bioworks ... to industrial engineering, was today awarded as one ... selection of the world,s most innovative companies. Ginkgo ... scale for the real world in the nutrition, ... engineers work directly with customers including Fortune 500 ...
(Date:6/24/2016)... ... June 24, 2016 , ... Researchers at the Universita ... miRNAs in people with peritoneal or pleural mesothelioma. Their findings are the subject of ... now. , Diagnostic biomarkers are signposts in the blood, lung fluid or tissue ...
Breaking Biology Technology:
(Date:4/28/2016)... First quarter 2016:   , Revenues amounted ... quarter of 2015 The gross margin was 49% (27) ... the operating margin was 40% (-13) Earnings per share ... operations was SEK 249.9 M (21.2) , Outlook   ... M. The operating margin for 2016 is estimated to ...
(Date:4/15/2016)...  A new partnership announced today will help ... in a fraction of the time it takes ... life insurance policies to consumers without requiring inconvenient ... Diagnostics, rapid testing (A1C, Cotinine and HIV) and ... weight, pulse, BMI, and activity data) available at ...
(Date:3/31/2016)... 2016   LegacyXChange, ... "Company") LegacyXChange is excited to release its ... to be launched online site for trading 100% guaranteed ... will also provide potential shareholders a sense of the ... an industry that is notorious for fraud. The video ...
Breaking Biology News(10 mins):