Navigation Links
Cyberonics Provides Update on Depression Post-Approval Study
Date:7/24/2009

HOUSTON, July 24 /PRNewswire-FirstCall/ -- Cyberonics, Inc. (Nasdaq: CYBX) today announced that the U.S. Food and Drug Administration ("FDA") has approved the company's proposal to amend the protocol of its D-21 post-approval dosing study in depression patients treated with VNS Therapy(TM).

The company submitted a proposal in November 2008 to reduce the number of study subjects from 460 to 330 and completed enrollment of 331 study subjects in February 2009. With this decision from the FDA, the company expects to complete the follow-up on all patients enrolled in the study by March 2010.

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.

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 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 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.

    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.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. CuraGen Provides Update on Velafermin, Belinostat and CR011-vcMMAE Clinical Development Programs
2. Access Pharmaceuticals Provides Update on Clinical Development Plan of ProLindac
3. Study Shows Combination Therapy Incorporating AVODART(R) and Tamsulosin Provides Continuous Symptom Improvement Over 2 Years
4. Raptor Pharmaceuticals Provides Update of Product Programs
5. Monogram Provides Update on Trofile(TM) Co-Receptor Tropism Assay
6. Arbios Provides Clinical Strategy for SEPET(TM) Pivotal Trial
7. Innocoll Provides a Progress Update on its Clinical Development Programs and Specialty Pharmaceutical Operations
8. Genaera Corporation Provides Highlights of Positive Phase 1 Trodusquemine (MSI-1436) Data from the North American Association for the Study of Obesity Annual Meeting
9. Favrille Provides Update on Timing of Analysis from Pivotal Phase 3 Clinical Trial; Reports Third Quarter 2007 Financial Results
10. Treatment with PEGASYS(R)/COPEGUS(TM) Provides Hope for Hepatitis C Patients Whose Infection Did Not Initially Respond to Peg-Intron(R)/Ribavirin
11. Improved Cornea Surgery Technique Provides Enhanced Transplant Success
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/12/2017)... AVACEN Medical , Inc. (AVACEN) announced that Frost & ... Innovation Award for Its fibromyalgia pain management device. The ... market research by Frost & Sullivan,s industry experts. ... product, the AVACEN 100, offers a safe and effective solution ... ...
(Date:10/11/2017)... , Oct. 11, 2017  BioPharmX Corporation (NYSE MKT: ... that developed an innovative way to use nonlinear optical ... delivery of new drugs. ... Dermatology Conference will show how researchers from BioPharmX and ... Medical School used a suite of imaging techniques in ...
(Date:10/11/2017)... , Oct. 11, 2017  Hill-Rom Holdings, Inc. ("Hill-Rom") ... Surgical facility in Las Piedras, Puerto Rico ... and blades. ... the facility sustained minor structural damage, temporary loss of ... Repairs have been completed, manufacturing operations have resumed, and ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... , ... Many families have long-term insurance that covers care for a family ... for care if the client has a cognitive impairment diagnosis. , “What this ... often waived, so the benefits from their insurance start immediately,” said Mechell Vieira, owner ...
(Date:10/13/2017)... , ... October 13, 2017 , ... ... be giving viewers the lowdown on sciatica in a new episode of "Success ... focuses on current events and innovation and investigates each subject in-depth with passion ...
(Date:10/12/2017)... ... October 12, 2017 , ... CitiDent ... sleep apnea using cutting-edge Oventus O2Vent technology. As many as 18 million ... by frequent cessation in breathing. Oral appliances can offer significant relief to about ...
(Date:10/12/2017)... ... October 12, 2017 , ... Asante, a nationally ... care, have expanded their existing home health joint venture through an agreement, effective ... operating a joint venture home health company with Asante, delivering clinically integrated care, ...
(Date:10/12/2017)... ... , ... On Saturday, October 21, the Health & Wellness Center at Florida ... money for the American Heart Association Heart Walk. Teams of up to 10 people ... keep their treadmills moving for 5 hours. Treadmills will start at 7:00 p.m. on ...
Breaking Medicine News(10 mins):