Cyberonics Reports Consistently Positive Results From The E-36 And E-37 Studies For VNS Therapy Delivered By AspireSR® Generator

HOUSTON, Dec. 8, 2014 /PRNewswire/ -- Cyberonics, Inc. (NASDAQ:CYBX), maker of the VNS Therapy^® System implanted in more than 80,000 patients, announced new results from two multi-site clinical studies of the AspireSR generator, E-36 (NCT01325623) and E-37 (NCT01846741), at the AES Annual Meeting in Seattle, Washington.  The AspireSR generator is currently investigational in the U.S. and not approved for commercial use.  The AspireSR generator attained the CE Mark and is now available in an increasing number of European countries.

Investigators presented results from the European E-36 study and the U.S. E-37 study, which assessed the acute impact of the AspireSR generator on seizure duration and termination, as well as the long-term evaluation of safety, clinical benefit of the automatic stimulation feature, and quality of life.  Assessments of seizure severity and quality of life were made using validated scales scored by patients[1],[2] and physicians[3].

The acute impact of the AspireSR generator on seizure duration and termination was evaluated during the Epilepsy Monitoring Unit stay period experienced by all patients in both studies.  Seizure activity was recorded using concurrent video-EEG and ECG monitoring.  Patients in both studies experienced termination of seizures as well as reduced seizure duration during automatic stimulation compared to historical controls.

During three- and six-month follow-up, patients in both studies experienced clinically significant reduction in several key components of seizure activity compared to baseline, including overall seizure severity, movements that could result in harm, and various aspects of post-ictal recovery. 

"These clinical results show that the AspireSR VNS Therapy System is safe and effective for detecting and reducing the burden of seizures in patients with drug-resistant epilepsy," said Paul A.J.M. Boon, MD, PhD, Professor and Chairman of the Department of Neurology and Director, Institute for Neuroscience, Ghent University Hospital.  "The AspireSR generator shows a similar clinical benefit to the manual magnet-activated stimulation provided by the existing VNS Therapy systems, but with added convenience to both the patient and caregiver."

"More than 60% of patients receiving VNS Therapy report benefits from manual magnet activation[4], yet not all patients can use this feature during a seizure as the result of the disabling effects of the seizure, cognitive impairment, seizures that occur during sleep, or seizures that occur without an aura," added Robert Fisher, MD, PhD, Director of the Stanford Epilepsy Center, Palo Alto, CA.  "The AspireSR generator delivers programmed VNS Therapy with the addition of automatic stimulation based upon the increased heart rate that accompanies many seizures.  This feature can provide the acute stimulation benefit to more patients with drug-resistant epilepsy."

About Drug-Resistant Epilepsy and VNS Therapy

Epilepsy is the fourth most common neurological disorder and one in 26 people will develop epilepsy at some point in their lifetime.  Antiepileptic drugs are typically the first option for treating epilepsy.  While many people with epilepsy have success with these drugs, as many as one-third of people with epilepsy experience seizures that persist in spite of treatment with medications alone.[5],[6]

Cyberonics' VNS Therapy System is an FDA-approved medical device specifically developed for the adjunctive treatment of drug-resistant (medically refractory) epilepsy.  Treatment with VNS Therapy does not involve brain surgery, but rather the implanted medical device delivers mild, pulsed electrical signals to the vagus nerve, which projects to areas of the brain that are known to be implicated in seizures.  Studies show that a majority of people with drug-resistant epilepsy experience a 50-90% reduction in seizures with VNS Therapy[7] and report improvements in quality of-life[8].

More information about VNS Therapy is available at vnstherapy.com or by contacting [email protected].  

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 FDA approval for and expanding the commercial market for the AspireSR generator.  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 the VNS Therapy System and sales of our products; the development and satisfactory completion of clinical studies; the achievement of regulatory approval for new products, including use of the VNS Therapy System for the treatment of other indications; satisfactory completion of the post-market registry 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 the Centers for Medicare & Medicaid Services, state Medicaid agencies and private insurers; the presence or absence of intellectual property protection and potential patent infringement claims; maintaining compliance with government regulations; 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 potential identification of material weaknesses in our internal controls over financial reporting; 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, 2014, and our Quarterly Report on Form 10-Q for the fiscal quarters ended July 25, 2014 and October 24, 2014.

Contact information

Greg Browne, CFO
Cyberonics, Inc.
100 Cyberonics Blvd.
Houston, TX 77058
Main:  (281) 228-7262
Fax:  (281) 218-9332
[email protected]

[1] Seizure Severity Questionnaire (SSQ), Cramer, JA. Epilepsy Research 2002;48:187‐197.

[2] Quality of Life in Epilepsy (QOLIE‐31‐P), Cramer JA, et. al. Epilepsia, 1998;39:81-88.

[3] National Hospital Seizure Severity Scale (NHS3), O'Donoghue, MF et. al. Epilepsia 1996;37:563‐571.

[4] Morris GL. Epilepsy and Behavior 2003;4:740-745.

[5] Kwan P., Brodie M.J. New England Journal of Medicine. 2000;342:314-319.

[6] Schiller Y., Najjar Y. Neurology 2008;70;54-65.

[7] Englot, D J, et al. J Neurosurg 2011;115:1248–1255.

[8] Ryvlin P, et. al. Epilepsia 2014;55 893‐900.

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SOURCE Cyberonics, Inc.

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