Healthcare Industry News: Treatment-Resistant Depression
News Release - September 11, 2006
Cyberonics Provides TRD Post Approval Patient Access and Outcomes UpdateHOUSTON, Sept. 11 (HSMN NewsFeed) -- Cyberonics, Inc. (Nasdaq: CYBX ) today provided an update on the access to VNS Therapy for patients with Treatment-Resistant Depression (TRD) and the outcomes of patients with TRD treated with VNS Therapy since FDA approval in July 2005.
"Since FDA approval in July 2005, more than 3,000 psychiatrists have sought Cyberonics' assistance with patient education and qualification, and insurance verification and prior authorization for more than 13,000 patients with TRD," commented Shawn P. Lunney, Cyberonics' Vice President of Market Development. "To date, more than 1,800 TRD patients have begun their treatment with VNS Therapy, while some 7,000 patients with TRD have been denied access to VNS Therapy by their payers. Three payers, who cover more than 1.5 million combined lives, have issued written coverage policies for VNS in TRD; case-by-case access to VNS Therapy for TRD has been granted by nearly 250 different payer plans; and more than 100 different plans have verbally notified Cyberonics' nurse case managers during prior authorization requests that VNS is a covered benefit under that patient's plan."
"We are actively working with the Center for Medicare and Medicaid Services (CMS) and numerous state Medicaid programs and large private payers to revise their existing VNS Therapy coverage policies to include TRD patients who have been either (a) previously treated with or refused treatment with ECT or (b) previously hospitalized for depression," continued Mr. Lunney. The first CMS public comment period closed last week. During that 30-day period, CMS received more than 1,300 comments supporting qualified psychiatrists' and fully-informed patients' access to VNS Therapy for TRD (http://www.cms.hhs.gov/MCD/viewnca.asp?nca_id=195&basket=nca:00313R:195:Vagus +Nerve+Stimulation+for+Treatment+of+Resistant+Depression+%28TRD%29:Open:1st+Re con:2 ) and fewer than 10 negative comments. The more than 1,300 favorable comments were provided by the American Psychiatric Association, more than 250 psychiatric thought leaders and psychiatrists; 175 other healthcare professionals including neurologists, surgeons, nurses, social workers and health economists; more than 650 TRD patients and family members, some 40 patient advocacy organizations including the National Alliance on Mental Illness (NAMI) and 17 NAMI affiliates, the Depression and Bipolar Support Alliance (DBSA) and 8 DBSA affiliates, the National Mental Health Association, the American Society for Suicide Prevention and the Epilepsy Foundation; and some 20 Senators and Congressmen. Our goal remains to provide qualified psychiatrists and their fully informed TRD patients with access to VNS Therapy more quickly than the three years it took Cyberonics and epilepsy advocates to provide neurologists and their epilepsy patients with access to VNS Therapy following epilepsy approval in 1997. We believe that the strong support expressed in the expert opinions provided to CMS and other payers will help qualified psychiatrists and TRD patients achieve the same access to VNS Therapy currently provided to epilepsy patients.
"Cyberonics created a web-based outcomes assessment database to collect long-term results of early post-approval experience with VNS Therapy in TRD. This initiative supplements the TRD Dosing Study and the TRD Registry required by FDA as part of its final approval, to collect outcomes data on patients treated with VNS Therapy in the first year following approval," commented Richard L. Rudolph, M.D., Vice President, Clinical and Medical Affairs and Chief Medical Officer. "TRDOutcomes uses standard physician assessment tools to rate patient outcomes and to collect data on stimulation parameters, concomitant treatments and healthcare utilization. To date, initial data has been collected on 50 TRD patients after three months of VNS Therapy. An average of 30% of patients were rated as much or very much improved across six functional outcomes. In addition, 34% of patients had a decrease in their antidepressant medications, 96% of patients had no ECT and 90% of patients had no hospitalizations in their first three months of treatment with VNS Therapy. We are encouraged by these early post-approval TRD outcomes, which are consistent with the post-approval outcomes of refractory epilepsy patients that were on average superior to those observed in the pre-approval studies."
ABOUT VNS THERAPY AND CYBERONICS
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," 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 obtaining favorable regional and national TRD coverage policies from CMS and private payers to give TRD patients access to VNS Therapy. Our actual decisions, performance and 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 Alzheimer's disease, anxiety, or other indications; 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 applications; 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 time needed to complete the Audit Committee's review of stock option grants, procedures, and practices; the results of the previously disclosed governmental inquiries and Audit Committee internal review; the impact of any restatement of the Company's financial statements or other actions that might be taken or required as a result of such inquiries or review; the potential identification of new material weaknesses in the Company's internal controls over financial reporting; risks and costs associated with such inquiries or review and any litigation relating thereto or to the Company's stock option grants, procedures, and practices (including the previously disclosed derivative action); uncertainties associated with the Company's hearing before the NASDAQ Listing Qualifications Panel to avoid possible delisting of the Company's stock from NASDAQ for failure to file timely periodic reports with the SEC; uncertainties associated with any appeal concerning any possible delisting by NASDAQ; and other risks detailed from time to time in the Company's filings with the Securities and Exchange Commission (SEC). For a detailed discussion of these and other cautionary statements, please refer to Cyberonics' most recent filings with the SEC, including its Form 10-K for the fiscal year ended April 29, 2005.
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