First-Ever Human NCP System Implantation in New Method of VNS Completed
Without Complications
HOUSTON, Aug. 7 /PRNewswire/ -- Cyberonics, Inc. (Nasdaq: CYBX) today
announced that the first patient in the pilot study of Vagus Nerve Stimulation
(VNS) for the treatment of obesity was implanted with bilateral (right and
left side) NeuroCybernetic Prosthesis (NCP(R)) Systems last week at Lenox Hill
Hospital in New York City. The female patient was implanted on Monday
July 31, 2000, with no complications and was released from the hospital on
Saturday, August 5, 2000. She will return to the hospital for routine follow-
up visits and treatment and will continue to be followed frequently during the
study. The NCP System is a pocket-watch sized device, much like a pacemaker,
that sends a mild stimulation to the vagus nerve.
This is the first patient implanted in the two-phase clinical study
approved in June of 2000 by the U.S. Food and Drug Administration (FDA). A
new method of vagus nerve stimulation (VNS), bilateral (left and right) VNS,
in the area of the diaphragm, is being used in the study of obesity.
Bilateral thoracic or abdominal VNS is different from unilateral left cervical
(neck area) VNS, which is used to treat epilepsy and is currently in
investigational studies for depression and Alzheimer's disease. In the first
phase of the obesity study, a total of six patients will be implanted. After
initial evaluation of these patients, up to 24 additional patients may be
implanted in Phase II, for a total of up to 30 implanted and treated patients.
The study will be conducted at up to four clinical sites including Lenox Hill
Hospital and The University of Texas-Houston Medical School.
Dr. Mitchell Roslin, lead investigator and attending surgeon in charge of
the Obesity Surgery Program under the direction of Dr. V. A. Subramanian,
Lenox Hill Hospital in New York City said, "It is quite exciting to announce
that the study's first patient was implanted without complication. This study
will have an element of patient blinding, with some patients initially
receiving stimulation shortly after implantation and some patients initially
receiving stimulation 3 months after implantation. Having been involved with
the preclinical research of VNS, which suggested that VNS may be an effective
treatment for obesity, it is especially gratifying to see the study progress
out of the laboratory and into the clinic. We are confident that enrollment
of additional patients for this first phase of the study will continue at a
rapid pace in the next few months."
Robert P. ("Skip") Cummins, Cyberonics' President and Chief Executive
Officer, commented, "All of us at Cyberonics are extremely pleased to have
another VNS clinical study now underway. This news follows our recent
announcement of the start of the VNS in depression pivotal clinical study and
the initiation of a pilot clinical study of VNS in Alzheimer's disease."
The annual economic costs of obesity in the United States from excess
medical expenses and loss of income are reported to exceed $68 billion, a
figure that does not include the more than $30 billion spent yearly on diet
foods, products and programs. According to the National Institutes of Health
(NIH) (http://www.nhlbi.nih.gov/guidelines/obesity/ob_home.htm), obesity is a
serious disorder with severe medical, personal, social, and financial
implications. Approximately one third of the general population of the United
States or 100 million people are estimated to be overweight. Approximately 66
million Americans are obese enough to qualify for treatment with medications
and 14 million of these people are morbidly obese. Morbid obesity causes
significant health problems such as heart disease, stroke, diabetes, certain
types of cancer, gout and gallbladder disease. Being obese can also cause
problems such as sleep apnea and osteoarthritis. Approximately 90 to 95
percent of the over 10 million diabetics in the United States have Type II
diabetes, with obesity being the major risk factor. The combination of
hypertension and obesity significantly increases the risk of congestive heart
failure, and other cardiac complications, as well as the frequency of cerebral
(brain) stroke. Obesity-related conditions are estimated to contribute to
300,000 deaths yearly, ranking second only to smoking as a preventable cause
of death.
Approximately 30,000 obese patients are treated surgically each year in
the United States at a cost of $10,000 to $20,000 per procedure. Many of
these patients do not obtain or sustain weight loss, with long-term efficacy
of surgery approximately 50-70%. Obesity surgery is typically an open
surgical procedure that involves general anesthesia and significant morbidity.
Cyberonics, Inc. (http://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 the potential timing, size, duration
and outcome of clinical studies. Our actual results may differ materially.
Important factors that may cause actual results to differ include our ability
to obtain appropriate regulatory and other approvals of our studies and the
size of these studies and rates of investigator recruitment and patient
enrollment and clinical outcome. 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.
SOURCE Cyberonics, Inc.
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Related links:
http://www.nhlbi.nih.gov/guidelines/obesity/ob_home.htm
http://www.cyberonics.com
CONTACT:
Pamela B. Westbrook, Vice President, Finance
& Admin/CFO of Cyberonics, Inc., 281-228-7200, ext. 275, or
pbw@cyberonics.com; or Helen Shik, 781-684-0770, ext. 6587, or
hshik@schwartz-pr.com, or Jayme Maniatis, 781-684-0770, ext.
6610, or jaymem@schwartz-pr.com, both of Schwartz Communications
for Cyberonics, Inc.
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