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EXHIBIT 99.1
For Additional Information:
Corporate Communications, Cygnus
(650) 369-4300 www.cygn.com
FOR IMMEDIATE RELEASE
CYGNUS RECEIVES THREE ADDITIONAL U.S. PATENTS
FOR THE GLUCOWATCH-Registered Trademark- BIOGRAPHER
REDWOOD CITY, CA - DECEMBER 14, 2000 - Cygnus, Inc. (Nasdaq: CYGN) announced
today that the United States Patent and Trademark Office recently issued
three patents relating to Cygnus' glucose monitoring systems, including the
GlucoWatch-Registered Trademark- Biographer. Most recently, on November 7,
2000, Cygnus received U.S. Patent No. 6,144,869, which relates to various
mathematical algorithms used in the GlucoWatch Biographer and is entitled
"Monitoring of Physiological Analytes." Earlier, on October 31, 2000, Cygnus
received U.S. Patent No. 6,141,573, which relates to features of Cygnus'
AutoSensor and is entitled "Chemical Signal-Impermeable Mask." On October 31,
2000, Cygnus also received U.S. Patent No. 6,139,718, which relates to
electrode advancements and is entitled "Electrode with Improved Signal to
Noise Ratio." These patents are assigned to Cygnus, Inc. With the inclusion
of these three patents, Cygnus has a total of nine issued U.S. patents
relating to noninvasive, frequent and automatic glucose monitoring, in
addition to numerous U.S. and foreign patent applications pending.
"We are pleased to receive these patents, as their addition to our existing
intellectual property portfolio provides further protection for our innovative
product in the glucose monitoring field," said John C Hodgman, Chairman,
President and Chief Executive Officer of Cygnus.
The GlucoWatch Biographer is a frequent, automatic, and non-invasive glucose
monitoring device intended for detecting trends and tracking patterns in glucose
levels in adults, 18 years and older, who have diabetes. The GlucoWatch
Biographer is designed to automatically measure glucose through the wearer's
skin as frequently as every 20 minutes, for up to 12 hours, through the ease and
convenience of a device worn like a wristwatch. Every reading is displayed to
the wearer and stored in memory. Stored readings can be reviewed at the touch of
a button. The GlucoWatch Biographer has the capability to alert users when
glucose levels are too high or too low, or are rapidly declining. These
situations may be hard to identify with currently available glucose testing
alone. The device is intended for use at home and in health care facilities to
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supplement, not replace, information obtained from standard blood glucose
monitoring devices. The frequency of the automatic and non-invasive readings
gives users and their caregivers more complete information about glucose levels,
potentially allowing them to make better-informed decisions regarding diet,
medication, and physical activities.
On December 6, 1999, Cygnus received a unanimous recommendation for approval of
its pre-market approval (PMA) application for the GlucoWatch Biographer from the
FDA's Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical
Devices Advisory Committee, subject to certain conditions. Cygnus received an
approvable letter from the FDA for its device the following May. An approvable
letter means that the FDA has reviewed Cygnus' PMA application, as well as its
own Advisory Committee's report and recommendation, and believes it will approve
the application, pending specific final conditions. The FDA's stated conditions
for approval of the GlucoWatch Biographer relate to manufacturing, final printed
labeling materials, and post-market evaluations of aspects of product
performance.
The World Health Organization estimates there are 125 million people worldwide
with diabetes. This number has increased 15% in the last ten years and is
expected to double by 2005. In the U.S., approximately ten million Americans
have been diagnosed with diabetes. Diabetes is a leading cause of death in the
U.S., and the complications of uncontrolled diabetes result in an estimated $98
billion in medical costs annually. The worldwide market for glucose measuring
products is expected to exceed $4.7 billion by 2002.
Cygnus, Inc., headquartered in Redwood City, California, develops and
manufactures non-invasive diagnostic medical devices, utilizing proprietary
biosensor technologies to satisfy unmet medical needs cost-effectively. The
company's current efforts are focused on a frequent, automatic, and non-invasive
glucose monitoring device (the GlucoWatch Biographer) and enhancements thereto.
THIS NEWS RELEASE CONTAINS FORWARD-LOOKING STATEMENTS REGARDING FUTURE EVENTS
AND THE FUTURE PERFORMANCE OF THE COMPANY THAT INVOLVE RISKS AND UNCERTAINTIES
THAT MAY CAUSE THE COMPANY'S ACTUAL RESULTS TO DIFFER MATERIALLY. SUCH FACTORS
INCLUDE GOVERNMENT APPROVALS, COMMERCIAL INTRODUCTION, AND MARKET ACCEPTANCE OF
THE GLUCOWATCH BIOGRAPHER. FURTHER, THERE CAN BE NO ASSURANCE THAT THE
APPROVABLE LETTER FROM THE FDA WILL RESULT IN APPROVAL FROM THE FDA FOR THE
GLUCOWATCH BIOGRAPHER. THERE CAN BE NO ASSURANCE THAT THE COMPANY WILL BE ABLE
TO ENTER INTO A COMMERCIALIZATION ALLIANCE OR ALLIANCES OR THAT THE COMPANY WILL
BE ABLE TO OUTSOURCE CERTAIN COMMERCIALIZATION CAPABILITIES FOR LAUNCH WITHOUT A
WORLDWIDE COMMERCIALIZATION ALLIANCE IN PLACE. THERE ALSO CAN BE NO ASSURANCE
THAT, IF THE COMPANY RECEIVES MARKETING APPROVAL FROM THE FDA AND SIGNS
COMMERCIALIZATION AGREEMENTS, THE PRODUCT CAN BE SUCCESSFULLY MANUFACTURED OR
MARKETED EITHER IN THE U.S. OR IN EUROPE. THE COMPANY REFERS YOU TO THE
DOCUMENTS THE COMPANY FILES FROM TIME TO TIME WITH THE SECURITIES AND EXCHANGE
COMMISSION, INCLUDING THE COMPANY'S ANNUAL REPORT ON FORM 10-K, QUARTERLY
REPORTS ON FORM 10-Q, AND CURRENT REPORTS ON FORM 8-K, WHICH CONTAIN
DESCRIPTIONS OF CERTAIN FACTORS THAT COULD CAUSE THE COMPANY'S ACTUAL RESULTS TO
DIFFER FROM THE COMPANY'S CURRENT EXPECTATIONS AND ANY FORWARD-LOOKING
STATEMENTS CONTAINED IN THIS NEWS RELEASE.
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