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EXHIBIT 99.1
[CYBERONICS LETTERHEAD]
For Release Monday, September 11, 2000; 4:05 PM EDT
Contacts:
At Cyberonics At Schwartz Communications
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Pamela B. Westbrook, ext. 275 Helen Shik, ext. 6587
Vice President, Finance & Admin/CFO Jayme Maniatis Ext. 6610
(281) 228-7200 (781) 684-0770
[email protected] jaymem or [email protected]
CYBERONICS, INC. CONFIRMS RECEIPT OF PRELIMINARY MEDTRONIC
PROPOSAL TO ACQUIRE CYBERONICS
CYBERONICS BOARD OF DIRECTORS ELECTS TO REMAIN INDEPENDENT TO PURSUE
EPILEPSY, DEPRESSION, ALZHEIMER'S DISEASE, OBESITY AND
OTHER PATENT PROTECTED OPPORTUNITIES
EVENING FOR INVESTORS WITH DEPRESSION AND OBESITY INVESTIGATORS IN
NEW YORK CITY ON TUESDAY, SEPTEMBER 12, 2000
HOUSTON, Texas, September 11, 2000 -- Cyberonics, Inc. (NASDAQ: CYBX)
today confirmed that it had received Medtronic Inc.'s preliminary proposal to
acquire Cyberonics for $26 a share in Medtronic stock. Cyberonics' Board of
Directors, with the assistance of the Company's financial advisor, Morgan
Stanley Dean Witter, has carefully considered the Medtronic proposal and has
elected to remain independent to pursue the Company's patent protected
opportunities for Vagus Nerve Stimulation in epilepsy, where the Company has FDA
approval, in depression, Alzheimer's Disease and obesity, where the Company
currently has clinical studies underway, and in other indications covered by the
Company's United States method patents.
Robert P. ("Skip") Cummins, Cyberonics' President and Chief Executive
Officer, commented, "Medtronic expressed interest in Cyberonics in the first
quarter of this calendar year when our stock was near its 52-week high of $28.25
per share. During the last six months we provided Medtronic with information and
met with Medtronic senior management on several occasions under a
confidentiality agreement to determine if a combination or other business
relationship with Medtronic would provide our shareholders with appropriate
near-term value. During the last six months our Board of Directors has
thoroughly reviewed our performance, prospects and long-term plans for our
Epilepsy Business Unit, our Depression Business Unit and our Obesity and Other
Indications Business Unit. The Board also engaged and consulted with our
financial advisor, Morgan Stanley Dean Witter, regarding the discussions with
Medtronic and their $26 a share preliminary proposal. Upon due consideration of
the Medtronic proposal, the Cyberonics Board has unanimously elected to remain
independent to pursue Cyberonics'
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significant opportunities in epilepsy, depression, Alzheimer's Disease, obesity
and other indications covered by our VNSTM method patent protected franchise."
Mr. Cummins continued, "In epilepsy, VNS has emerged as one of the most
successful implantable electrical stimulation devices in history and Cyberonics
has developed a profitable business model for selling revolutionary device-based
approaches to medical doctors with no device experience. In fiscal 2000, our
epilepsy Business Unit reported 60% annual sales growth and a 93% improvement in
bottom line performance. Regarding new indications, we currently have clinical
studies underway using VNS to treat depression, Alzheimer's Disease and obesity.
In depression, we recently completed a 60 patient pilot study with very
encouraging results. A 20 center, net 210 patient FDA-approved Phase III
depression pivotal study is underway. As of today we have 12 active key opinion
leading centers, and 24 enrolled and eight implanted patients in the depression
pivotal study. We are also making excellent progress in the Alzheimer's and
obesity pilot studies. In the 10 patient Alzheimer's pilot which is being done
in Sweden at Sahlgrenska Hospital, one patient has been implanted. In obesity, a
six subject canine study was completed in 1999 with encouraging results. In
June, 2000, we received FDA approval of a 30 patient, two-phase pilot study of
bilateral supradiaphragmatic VNS for obesity. So far we have 2 IRB approvals,
and one patient implanted in the obesity pilot."
The evening for investors with the depression and obesity investigators
will be held at the Waldorf=Astoria, 301 Park Avenue, New York City, from 6:00 -
11:00 p.m. on Tuesday, September 12, 2000. Speakers include depression
investigators Dr. Mark George from Medical University of South Carolina, Dr.
Lauren Marangell from Baylor College of Medicine and Dr. Harold Sackeim from
Columbia University, a depression patient from the pilot study and Dr. Mitch
Roslin from Lenox Hill Hospital, the principal obesity investigator. Please call
Kathryn Brown at 281-228-7368 if you are interested in attending this meeting.
Space at this late date is limited.
Vagus Nerve Stimulation therapy is delivered by the Cyberonics NCP(R)
System, an implantable medical device similar to a cardiac pacemaker. A
stopwatch-sized generator is implanted in the left chest and a nerve stimulation
electrode is attached to the vagus nerve in the neck in a one to two hour
procedure typically done on an outpatient basis. Using an external programmer,
the physician can set or reset the stimulation parameters of the device. The
system delivers preprogrammed intermittent -- for example, 30 seconds on, five
minutes off -- electrical pulses to the vagus nerve 24 hours a day. The first
human implant of the system occurred in 1988 in a patient with epilepsy. On July
16, 1997, the FDA approved VNS with the Cyberonics NCP System as an adjunctive
therapy for the treatment of medically refractory partial onset seizures in
adults and adolescents over 12 years of age. To date, more than 9,000 epilepsy
patients in 24 countries have accumulated over 14,000 patient years of
experience using Vagus Nerve Stimulation. The most common side effects of VNS
seen in patients with refractory epilepsy are voice alteration, shortness of
breath, discomfort and coughing, all of which occur during the actual
stimulation. The NCP System is not authorized for use in the treatment of
depression and is in the early stages of investigation for this use.
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Cyberonics, Inc. (www.cyberonics.com) was founded in 1987 to design,
develop and market medical devices for the treatment of epilepsy and other
debilitating disorders using a unique therapy, vagus nerve stimulation. The
Company's initial target market is epilepsy, the world's second most prevalent
neurological disorder, which is characterized by recurrent seizures. Vagus nerve
stimulation with the Cyberonics NCP System was approved by the FDA on July 16,
1997 for use as an adjunctive therapy in reducing the frequency of seizures in
adults and adolescents over 12 years of age with medically refractory partial
onset seizures. In addition to the U.S., the NCP System is currently approved
for sale as a treatment for epilepsy in all the member countries of the European
Union, Canada, Australia and other markets. Vagus nerve stimulation delivered by
the NCP System is at various levels of investigational clinical study as a
potential treatment for severe depression, obesity and Alzheimer's disease.
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. Such forward-looking statements
include statements concerning: transitioning VNS therapy from a revolutionary
treatment to a standard of care in epilepsy; developing VNS as a treatment for
depression, Alzheimer's Disease, obesity and other indications; the timing and
outcome of clinical studies; improving our productivity and efficiencies;
substantially increasing our sales while only modestly increasing our operating
expenses, and achieving profitability. These predications 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.
Our actual results may differ materially. Important factors that may cause
actual results to differ include: ongoing safety and efficacy of VNS with the
Cyberonics NCP System; the overall rate of demand for the Company's products;
the Company's ability to hire, train and retain key personnel; the Company's
ability to maintain all appropriate regulatory approvals; the Company's ability
to develop and maintain adequate manufacturing capacities and sources of supply;
the timing and results of future clinical studies; the rate at which overall
corporate infrastructure will be developed and the amount of timing of
expenditures related to those and other activities; and management's ability to
accurately forecast future events. For further discussion of these and other
important factors that could affect the Company's activities and results, please
refer to the Company's Annual Report on Form 10-K for the year ended June 30,
1999 and the Company's Quarterly Report on Form 10-Q for the periods ended
September 30, 1999, December 31, 1999 and March 31, 2000.
NCP is a registered trademark of Cyberonics, Inc. VNS is a trademark of
Cyberonics, Inc.
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