Cyberonics Announces FDA Approval Of The AspireSR® Generator For VNS Therapy®
HOUSTON, June 2, 2015 /PRNewswire/ -- Cyberonics, Inc. (NASDAQ: CYBX) today announced FDA approval of the AspireSR® generator for the VNS Therapy® System – the first and only VNS Therapy System that provides responsive stimulation to heart-rate increases that are often associated with seizures in people with epilepsy. Studies have shown that 82 percent of patients with epilepsy experience rapid heart-rate increase associated with a seizure.1 The AspireSR generator uses a proprietary, patent protected, customizable cardiac-based algorithm to detect relative heart-rate increases and deliver automatic stimulation.
Seizure timing is often unpredictable, causing stress to patients and anxiety to caregivers, knowing that a seizure could occur when they are not prepared or able to intervene. "From a physician's perspective, the AspireSR generator is a very important development, because it is the only minimally invasive option we have that allows us to detect and respond to events in real time," added Micheál P. Macken, M.D., M.R.C.P.I., Assistant Professor of Neurology, Department of Neurology, Northwestern University Feinberg School of Medicine.
Matthew Busby (a patient of Mr. Ramesh Chelvarajah, a neurosurgeon at Queen Elizabeth Hospital in Birmingham, UK, where the AspireSR generator has had CE mark approval since February 2014) has noticed a significant reduction in daytime seizures and has not experienced any nighttime seizures since receiving VNS Therapy with the AspireSR generator. "My message is to stay positive and recognize that many people may have options beyond drug treatment – and they should talk to their physician about what's possible," said Busby. Consistent with Matthew's experience, many patients in the AspireSR generator clinical studies experienced seizure frequency reduction, reduced seizure severity and improved postictal recovery.
"The AspireSR generator is a groundbreaking advancement in VNS Therapy and represents the essence of our DNA™ Technology – Detect, Notify, Act," said Dan Moore, President and CEO of Cyberonics. "Our ability to design and implement algorithms that detect physiological conditions provides a foundation for this and future products and adds an important dimension to what 'smart' devices can accomplish to help improve the lives of patients globally.
"We will provide more information on our U.S. commercialization plans during our previously scheduled earnings call on Thursday, June 4, 2015 at 8:00 a.m. (CDT)," concluded Mr. Moore.
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. Seizure medications 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.2,3
The VNS Therapy System is an FDA-approved medical device specifically developed for the adjunctive treatment of drug-resistant (medically refractory) epilepsy. Treatment with the VNS Therapy System does not involve brain surgery, but rather the medical device – implanted in a simple, out-patient procedure under the skin of the chest – delivers mild, pulsed electrical signals to the vagus nerve, which project 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 to 90 percent reduction in seizures with the VNS Therapy System4 and report improvements in quality of-life.5
More information about VNS Therapy is available at 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 increasing sales as a result of the FDA approval of 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,October 24, 2014 and January 23, 2015.
Contact information
Greg Browne, CFO
Cyberonics, Inc.
100 Cyberonics Blvd.
Houston, TX 77058
Main: (281) 228-7262
Fax: (281) 218-9332
[email protected]
1 Eggleston KS, et al. Seizure. 2014 (Aug;23(7):496-505
2 Kwan P., Brodie M.J. New England Journal of Medicine. 2000;342:314-319
3 Schiller Y., Najjar Y. Neurology 2008;70;54-65
4 Englot, D J, et al. J Neurosurg 2011;115:1248-1255
5 Ryvlin P, et al. Epilepsia 2014; 55 893-900
SOURCE Cyberonics, Inc.
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