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Total Number of Pages: 3
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UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported) June 2, 1999
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CYGNUS, INC.
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(Exact name of registrant as specified in charter)
DELAWARE 0-18962 94-2978092
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(State or other jurisdiction (Commission (IRS Employer
of incorporation) File Number) Identification No.)
400 PENOBSCOT DRIVE, REDWOOD CITY, CALIFORNIA 94063-4719
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(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code (650) 369-4300
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NOT APPLICABLE
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(Former name or former address, if changed since last report.)
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Item 5. OTHER EVENTS.
On June 2, 1999, Cygnus, Inc. issued a press release, the text of
which is attached hereto as Exhibit 99.1, announcing the submission of the
second and final module of its Pre-Market Approval Application (PMA) to the
United States Food and Drug Administration (FDA) for the GlucoWatch (Registered
Trademark) Automatic Glucose Monitor. The Company also announced that they are
in discussions with a short list of potential partners for the marketing and
distribution of the GlucoWatch monitor in North America and Europe.
Item 7. Financial Statements and Exhibits.
(c) Exhibits.
Exhibit Number
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99.1 Press Release by Cygnus, Inc. dated June 2, 1999
referred to in Item 5 above.
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SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
CYGNUS, INC.
DATE: June 2, 1999 By: /s/ Barbara G. McClung
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Name: Barbara G. McClung
Title: Senior Vice President and General Counsel
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EXHIBIT INDEX
EXHIBIT
NUMBER DOCUMENT DESCRIPTION
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99.1 Press Release by Cygnus, Inc. dated June 2, 1999. Refer to Item
5 above.
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EXHIBIT 99.1
FOR ADDITIONAL INFORMATION:
Craig Carlson/CFO, Cygnus
(650) 369-4300 www.cygn.com
Burns McClelland (212) 213-0006
Justin Jackson - Media
FOR IMMEDIATE RELEASE
Cygnus Completes Pre-Market Approval Application for
the GlucoWatch (Registered Trademark) Monitor
Redwood City, CA, June 2, 1999 - Cygnus, Inc. (Nasdaq: CYGN) announced today it
submitted the second and final module of its Pre-Market Approval Application
(PMA) to the United States Food and Drug Administration (FDA) for the
GlucoWatch (Registered Trademark) Automatic Glucose Monitor, a wrist-worn
device intended to provide frequent, automatic and non-invasive monitoring of
glucose levels for adults with diabetes (age 18 and older). It is anticipated
that this type of previously unavailable information may provide better
understanding of the effects of diet, medication and activities on blood
glucose levels. The FDA will evaluate the safety and effectiveness of the
GlucoWatch monitor as a tool to enable people with diabetes and health care
professionals to make better decisions about diabetes management.
The second module of the PMA includes analysis of a series of clinical studies.
These studies involved participation of hundreds of people with diabetes who
used the device for up to six weeks. The studies, which were performed at more
than 15 clinical sites across the United States, involved over 25,000 hours of
use of the GlucoWatch monitor. The participants consisted of a cross-section of
racial and age groups, diabetes types (both type 1 and type 2), and other
defining characteristics. Approximately 19,000 paired data points were generated
from the studies comparing glucose measurements obtained by the GlucoWatch
monitor to glucose measurements obtained with finger-stick monitors using
capillary blood. The PMA application to the FDA was initiated on January 25,
1999 with the submission to the FDA of manufacturing and other documentation.
"The completion of the PMA submission, a month earlier than anticipated,
represents a significant milestone in the development of the GlucoWatch
monitor," stated John C. Hodgman, President and Chief Executive Officer,
Cygnus, Inc. "Looking forward, we are eager to work with the FDA to answer any
questions they may have as they review our submission," Mr. Hodgman added.
"Additionally, we are in discussions with a short list of potential partners
for the marketing and distribution of the GlucoWatch monitor in North America
and Europe."
Pending FDA approval, the GlucoWatch monitor has the potential to provide a
novel means of monitoring glucose levels for people with diabetes. Currently
available glucose monitors offer only "episodic" testing. The user only obtains
a glucose reading when he or she remembers to test and takes the necessary time
away from daily activities. Each of these readings from a traditional home
blood glucose meter requires a painful finger-stick to obtain a blood sample.
In current medical practice, home blood glucose meters are used to obtain just
a few (typically one to four) measurements per day. This provides little
information about the true variability and trends in glucose levels. The result
for most people is poor control of glucose levels, which can lead to
catastrophic complications over time.
The GlucoWatch monitor is a wrist-worn device intended to provide frequent,
automatic and non-invasive monitoring of glucose levels. The device is intended
for home and clinical use in adults (age 18 and older) with diabetes. The
monitor provides up to three glucose readings per hour for 12 hours (36 total
readings) after a single point calibration with the results from a traditional
finger-stick meter. GlucoWatch monitor readings can be obtained even when
patients would otherwise be unable to test (e.g., during sleep). In addition,
the device is expected to offer the capability of sounding an alert if glucose
levels get too high or too low. The GlucoWatch monitor will store the most
recent 4,000 glucose readings.
The GlucoWatch monitor works through a process called reverse iontophoresis.
This process allows the monitor to collect glucose samples through intact skin.
The glucose molecules are collected in gel collection discs that are part of a
single-use AutoSensor. The gel collection discs contain the enzyme glucose
oxidase. As glucose enters the discs, it reacts with the glucose oxidase in the
gel to form hydrogen peroxide. A biosensor in contact with each gel collection
disc detects the hydrogen peroxide, generating an electronic signal. The
monitor uses the calibration value previously entered by the patient to convert
the signal into a glucose measurement. The glucose measurement is then
displayed on the monitor and stored in memory.
Diabetes, which afflicts 16 million people in the U.S. and accounts for
approximately $100 billion in health care costs annually, is a chronic disease
characterized by the body's inability to produce or properly use insulin. This
disease is the fourth leading cause of death by disease in this country.
Effective diabetes management includes frequent and consistent glucose
monitoring.
Cygnus is engaged in the development and manufacture of diagnostic and drug
delivery systems utilizing its proprietary technologies to satisfy unmet medical
needs cost effectively. Cygnus' current efforts are primarily focused on two
core areas: a frequent, automatic and non-invasive glucose monitoring device
(the GlucoWatch device) and transdermal drug delivery systems.
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 the government approvals, commercial introduction and market acceptance
of the GlucoWatch monitor. There can be no assurances that the results achieved
in the clinical studies would result in the FDA clearing this device for market
approval. Also, there can be no assurance that the Company will sign a
marketing and distribution agreement for the GlucoWatch monitor or, if it does,
that the terms of the agreement would result in a promising financial outlook.
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.
END
