Cyberonics Announces FDA Approval of Re-Designed AspireHC™ Generator for VNS

Cyberonics Announces FDA Approval of Re-Designed AspireHC™ Generator for VNS « on: January 03, 2012, 11:29:36 AM »

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Cyberonics, Inc. (NASDAQ: CYBX) today announced that the United States Food and Drug Administration (FDA) has approved its re-designed AspireHC (High Capacity) generator, which was the subject of a voluntary product withdrawal in August 2011.

"We are pleased that the FDA was able to complete its review in approximately 60 days, enabling us to resume our limited commercial release of the AspireHC generator in the United States," said Dan Moore, Cyberonics' President and Chief Executive Officer. "With the CE Mark approval announced in December and a recently obtained Canadian approval, we will also resume the limited commercial release in Europe and initiate a limited commercial release in Canada. The AspireHC generator addresses a need among some patients for a device with a higher capacity battery and also provides a platform for the AspireSR™ seizure response generator, which is the subject of our E-36 clinical trial in Europe. We anticipate submission of the re-designed AspireSR generator for ethics committee and competent authority approvals for the E-36 clinical trial no later than the end of our fiscal year in April 2012."

http://www.prnewswire.com/news-releases/cyberonics-announces-fda-approval-of-re-designed-aspirehc-generator-for-vns-therapy-136586138.html

Re: Cyberonics Announces FDA Approval of Re-Designed AspireHC™ Generator for VNS « Reply #1 on: Today at 04:18:45 AM »

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Big mistake! But this may be the one that ends the charade!

FDA Clears Cyberonics' AspireHC

By: Zacks Equity Research

January 04, 2012 |Comments: 0

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MDT | CYBX

Cyberonics

(CYBX) recently received approval from the US Food and Drug Administration (FDA) for its re-designed AspireHC (High Capacity) generator whose shipment was discontinued by the company earlier.

Earlier, in February 2011, this major neuromodulation company received FDA approval for AspireHC, a new and improved generator to be used in vagus nerve stimulation (VNS) therapy. However, later in July, Cyberonics had to discontinue shipment of two models of its Aspire platform generators.

The decision was based on the realization that stimulation output delivered to patients was less than that programmed by a physician. The company also suspended enrollment in its E-36 clinical trial pending resolution of this hardware related design issue. In October, Cyberonics had submitted applications to the FDA and European notified body, DEKRA Certification, B.V. for redesigning the AspireHC generator.

In addition to gaining FDA approval, Cyberonics recently achieved Renewal Approval of CE Mark, which enables the company to keep on selling VNS Therapy System for the treatment of refractory epilepsy and depression in the European Union and Canada. Cyberonics presently plans to resume the limited commercial release of the AspireHC generator in Europe and initiate a limited commercial release in Canada.

Cyberonics’ AspireHC generator represents the fifth generation of VNS Therapy. It has a longer battery life, more user-friendly features and improved electronics that prove more beneficial to VNS patients as well as physicians. The FDA approval of AspireHC is expected to pave the way for the AspireSR seizure response system generator, which is the subject of the E-36 clinical trial in Europe. Cyberonics plans to submit the re-designed AspireSR generator to the ethics committee and competent authority approvals for the E-36 clinical trial by the end of its fiscal 2012.

Presently, about 118 people worldwide have been provided with the AspireHC or AspireSR generators. Prior to the withdrawal of AspireHC generator, this model contributed around 9% of worldwide sales of Cyberonics. The company believes that the re-designed model of AspireHC will regain sales growth in the upcoming quarters.

Recommendation

Amidst several headwinds in the form of shipment cancellation, mounting third-party reimbursement issues along with stiff competition in the neuromodulation space from players like Medtronic (MDT) and St. Jude Medical Inc. (STJ), the re-designed product approval of Cyberonics is a relief for the company. Additionally, the company’s effort to expand in Europe, Japan, Latin America, China and India is encouraging. The company is investing in these countries which should boost its international performance in the rest of fiscal 2012. Presently, Cyberonics retains a Zacks #3 Rank (Hold) in the short term, in line with long-term Neutral recommendation on the stock.

http://www.zacks.com/stock/news/67257/FDA+Clears+Cyberonics'+AspireHC

CYBERONICS ANNOUNCES HOLD ON SHIPMENT AND RETRIEVAL OF INVENTORY OF AspireHC™ AND AspireSR™ GENERATORS

For Release Monday, August 15, 2011; 8:00 AM ET

CYBERONICS ANNOUNCES HOLD ON SHIPMENT AND RETRIEVAL OF INVENTORY OF AspireHC™ AND AspireSR™ GENERATORS

COMPANY AFFIRMS FINANCIAL GUIDANCE FOR FISCAL 2012

HOUSTON, Texas August 15, 2011 -- Cyberonics, Inc. (NASDAQ:CYBX), a global leader in devices for epilepsy management, announced today that it has voluntarily stopped shipment and is retrieving field inventory of its Aspire platform generators, Models 105 and 106.  The company does not believe that the generators pose a health risk to patients, but initiated this action when it discovered that stimulation output current delivered to patients can be less than the output current programmed by a physician.  Instructions will be provided to physicians regarding management of the approximately 118 patients worldwide who have been implanted with an AspireHC or AspireSR generator.  Cyberonics has also suspended enrollment in its E-36 clinical trial pending resolution of this hardware-related design issue.

“Patient safety is our first priority.  We are working expeditiously to resolve this problem.  Our product development team has identified what we believe to be the cause of the problem, as well as several potential hardware solutions,” said Dan Moore, President and Chief Executive Officer.  “Our goal is to implement and validate a solution and submit for regulatory approvals by no later than the end of the fiscal year.”

The company, which completed the first quarter of fiscal 2012 on July 29, 2011 and will report financial results on August 25, 2011, does not currently anticipate a change to guidance for fiscal year 2012 as a result of this action. The previously provided guidance remains at $212 million to $215 million for net sales, and $54 million to $57 million for income from operations.  Sales for the AspireHC (Model 105) generator comprised approximately 9% of worldwide revenue in the recently completed first quarter, and the company believes that the availability of alternate models provides physicians and patients with appropriate additional options for the treatment of refractory epilepsy.

About Cyberonics, Inc. and the VNS Therapy^® System

Cyberonics, Inc. is a medical technology company with core expertise in neuromodulation.  The company developed and markets the VNS Therapy System, which is FDA-approved for the treatment of refractory epilepsy and treatment-resistant depression.  The VNS Therapy System uses a surgically implanted medical device that delivers electrical pulsed signals to the vagus nerve.  Cyberonics markets the VNS Therapy System in selected markets worldwide.

Additional information on Cyberonics and the VNS Therapy System is available at www.cyberonics.com.