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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) July 20, 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 July 20, 1999, Cygnus, Inc. issued a press release, the
text of which is attached hereto as Exhibit 99.1, announcing that the United
States Food and Drug Administration (FDA) notified Cygnus that the pre-market
approval application (PMA) for the GlucoWatch (Registered Trademark) monitor
has been deemed suitable for filing. The FDA also granted an expedited review
status for Cygnus' GlucoWatch (Registered Trademark) Automatic Glucose
Monitoring device.
Item 7. Financial Statements and Exhibits.
(c) Exhibits.
Exhibit Number
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99.1 Press Release by Cygnus, Inc. dated July 20, 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: July 27, 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 July 20, 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 McClellan (212) 213-0006
Justin Jackson/Lisa Fern - Media
FOR IMMEDIATE RELEASE
Cygnus' GlucoWatch (Registered Trademark) Automatic Glucose Monitoring
Device Granted Expedited Review Status by the FDA
Redwood City, CA - July 20, 1999 - Cygnus, Inc. (Nasdaq: CYGN) today announced
it received notification from the United States Food and Drug Administration
(FDA) that the pre-market approval application (PMA) for the GlucoWatch
(Registered Trademark) monitor has been deemed suitable for filing. The
Company was also informed by the FDA that the GlucoWatch (Registered
Trademark) monitor, a frequent, automatic and non-invasive glucose monitor,
has been granted expedited review status. In addition, the FDA stated that
the GlucoWatch (Registered Trademark) monitor will be reviewed by the Clinical
Chemistry and Toxicology Devices Panel at a yet to be determined date.
"The FDA informed us that we will receive expedited processing 'because the
availability of your device as a tool in diabetes management is in the
interest of public health'," stated John C. Hodgman, President, Chief
Executive Officer and Chairman of Cygnus. "We believe the GlucoWatch
(Registered Trademark) monitor can provide the information people need to
better control their glucose levels. We look forward to working closely with
the FDA as they proceed with the expedited review process," Mr. Hodgman added.
The GlucoWatch (Registered Trademark) monitor is intended for use by adults,
18 years and older, who have diabetes. Following a three-hour warm-up period,
the device is capable of providing up to three non-invasive glucose
measurements per hour for 12 hours. After the warm-up period, a finger stick
blood glucose measurement is input into the GlucoWatch (Registered Trademark)
monitor for calibration. Due to the frequency of the automatic and
non-invasive measurements, the GlucoWatch (Registered Trademark) monitor has
the potential to provide heretofore unavailable information about glucose
levels. This has the potential to result in better decisions about all
aspects of diabetes management. In addition, the device has the capability of
sounding alarms in response to results outside of high and low thresholds
selected for each user. This can provide a method to reduce the risk of
hyper- and hypoglycemia.
The GlucoWatch (Registered Trademark) 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.
The final module of Cygnus' PMA application, which was submitted to the FDA
last month, included analyses 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 (Registered Trademark) 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 (Registered Trademark) monitor to glucose measurements
obtained with finger-stick monitors using capillary blood.
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 monitoring device
(the GlucoWatch - Registered Trademark - 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 (Registered Trademark) monitor. There can be no
assurances that the FDA will clear this device for market approval as
expedited review status does not guarantee that the application will
ultimately be approved. Also, there can be no assurance that if the Company
receives clearance from the FDA to market the device that the product could be
successfully marketed or manufactured. 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
