Cyberonic press release

FDA Deems Cyberonics' VNS Therapy™ System Approvable for Chronic or Recurrent Treatment-Resistant Depression (TRD)

Wednesday February 2, 7:22 pm ET

Conference Call Scheduled for Thursday, February 3 at 9:00AM EST
Q3 Sales and Earnings Likely to Beat Guidance; Q3 Earnings Release Scheduled for Tuesday, February 8; Merrill Lynch Global Healthcare Conference Presentation and Investor Dinner Scheduled for Wednesday, February 9


HOUSTON, Feb. 2 /PRNewswire-FirstCall/ -- Cyberonics, Inc. (Nasdaq: CYBX - News) today announced that the United States Food and Drug Administration (FDA) has deemed the Vagus Nerve Stimulation Therapy System (VNS Therapy) approvable as a long-term adjunctive treatment for patients over the age of 18 with chronic or recurrent treatment-resistant depression in a major depressive episode that has not responded to at least four adequate antidepressant treatments. In the approvable letter received today by Cyberonics, FDA indicated that final approval was conditional on final labeling, final protocols for a post- approval dosing optimization study and patient registry, satisfactory compliance with Quality System Regulations (QSR) and satisfactory resolution of any outstanding bioresearch monitoring issues.

Major depressive disorder is one of the most prevalent and serious illnesses in the U.S., affecting nearly 19 million Americans every year. Depression is the second leading cause of disability for the general population and the leading cause of disability for American women. Approximately 20 percent of depressed Americans, or approximately four million people, experience chronic or recurrent treatment-resistant depression that has failed to respond to multiple antidepressant treatments. If approved, the VNS Therapy System will be the first implantable device-based treatment for depression and the first treatment developed, studied and labeled specifically for patients with treatment-resistant depression.

"FDA's timely landmark approvable decision is a major step towards providing millions of Americans suffering from chronic or recurrent treatment- resistant depression, their families, psychiatrists and payers exactly what they desperately need -- an FDA-approved, informatively labeled, long-term treatment option specifically for their lifelong and life-threatening illness," commented Robert P. ("Skip") Cummins, Cyberonics' Chairman of the Board and Chief Executive Officer. "Over six years ago, Cyberonics embarked on a seemingly impossible pioneering journey to develop the first therapy for treatment-resistant depression. Today's approvable decision is a tribute primarily to (1) over 400 courageous Americans with treatment-resistant depression who participated in the VNS studies and testified at the Advisory Panel meeting, (2) psychiatric thought leaders like Drs. John Rush, Harold Sackeim, Mark George and Lauren Marangell who provided invaluable leadership, guidance and support over the past six years throughout the studies and approval process, (3) FDA's Center for Devices and Radiological Health, under the leadership of Dr. Dan Schultz, who expedited the review of the PMA- Supplement Amendment submitted approximately 120 days ago, and (4) the dedicated men and women of Cyberonics who never waiver from their mission to improve the lives of people touched by chronic, treatment-resistant disorders.

"Cyberonics and FDA have already made good progress towards resolving the approvable conditions, and based on that progress, Cyberonics is building its organization to support a potential late May 2005 launch in conjunction with the annual American Psychiatric Association meeting," continued Mr. Cummins. "Cyberonics and FDA have already agreed on the protocol synopses for the post- approval dosing study and patient registry. The full protocols will be submitted to FDA in the next several weeks. FDA is reviewing the labeling, which includes the Physician's and Patient's Manuals, and expects to complete that review in a timely manner. Cyberonics is aware of only one bioresearch monitoring issue and will work with FDA to resolve that issue promptly. Last but not least, Cyberonics submitted its Warning Letter responses, including a list of planned and already implemented corrective actions, on January 21 and expects to meet with the Dallas District Office in late February to resolve any remaining QSR issues.

"FDA's approvable decision is a major step towards the transformation of VNS Therapy, Cyberonics and the neuromodulation industry," continued Mr. Cummins. "Cyberonics' mission is to improve the lives of people touched by medically refractory epilepsy, treatment-resistant depression and other inadequately treated chronic disorders that prove to be treatable with our patented therapy, VNS. Today, the urgent unmet medical need in treatment- resistant depression is more than ten times the unmet medical need in epilepsy. There are an estimated four million Americans who suffer from treatment-resistant depression versus some 400,000 who have medically refractory epilepsy. In epilepsy, VNS is one of many FDA-approved adjunctive treatments for medically refractory partial onset seizures, whereas in depression, if final approval occurs, VNS will be the only FDA-approved treatment specifically for chronic or recurrent treatment-resistant depression.

"Cyberonics and VNS Therapy are much better prepared to improve the lives of people touched by TRD today than they were in 1997, at the time of epilepsy approval, to improve the lives of people with medically refractory epilepsy," continued Mr. Cummins. "Unlike the epilepsy market in 1997, today in TRD, there is considerable awareness of not only the urgent unmet medical need, but also the unique potential value of VNS as a treatment for TRD. Also unlike 1997, VNS is today a widely accepted, safe, effective and cost-effective therapy with good coverage, coding and reimbursement, whose approved use, like so many anti-epileptic drug precedents, is expanding to another indication. Last but not least, the Cyberonics of today bears little resemblance to the Cyberonics that launched the first device-based treatment in epilepsy in 1997."

"Cyberonics expects that third quarter sales and earnings will likely beat our guidance of $25 million in sales and a net loss of $3.3 million or $0.13 per fully diluted share," added Pamela B. Westbrook, Vice President, Finance and Administration and Chief Financial Officer. "The third quarter earnings release will occur on the morning of Tuesday, February 8. We will provide fourth quarter guidance at that time. Cyberonics' presentation at the Merrill Lynch Global Healthcare Conference and an Investor Dinner at the Grand Hyatt Hotel in New York City will all occur on Wednesday, February 9. Our highest priority for Q4 is to prepare our organization to support a potential TRD launch in late May. As a result, depression expenses will increase and we will invest an increasing amount of our U.S. sales force's time in depression training activities."

Link

In otherwords....

Cyberonics thinks that the FDA might approve it!

(That was a Cyberonics press release, not an FDA statement.)

If you've been following the Cyberonics/FDA situation, some folks said that the FDA would approve the VNS for depression by January 31.

Well... January 31 has come and gone without approval. They had to say something to keep the investors happy!!

Seems like every time Skip opens his mouth he just digs himself into a deeper hole.

Reuters Link to article

The Yahoo CBX board is going to LOVE this - Cha ching!

That last bit in the article

is the real kicker due to the fact that there are numerous manufacturing and trial issues.

Those bookkeeping and housekeeping issues won't be cleaned up by March, or June, or August. This is just a little bone for the shareholders to knaw on for awhile - to shut them up! :blink:

http://www.cyberonics.com/

Final approval, if it happens will come in May, 05. Like I said this was a press release from CYBX and NOT an official FDA approval statement.

I would like to see exactly how the FDA words the approval, since it is restrictive, this is going to be important for insurance approval and payment.

Since there is a carry oveof treatment with Epilepsy and Depression, I wonder why nobody has considered the Ketogenic Diet for depression.