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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) October 27, 1999
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CYGNUS, INC.
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(Exact name of registrant as specified in its 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 October 27, 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) has scheduled December 6, 1999 as
the date for an advisory committee review of Cygnus' premarket approval
application (PMA) for their GlucoWatch (Registered Trademark) monitor, an
investigational device intended to provide frequent, automatic and non-
invasive monitoring of glucose levels for adults with diabetes.
Item 7. Financial Statements and Exhibits.
(c) Exhibits.
Exhibit Number
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99.1 Press Release by Cygnus, Inc. dated October 27, 1999
referred to in Item 5 above.
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SIGNATURES
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: October 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 October 27, 1999. Refer to Item
5 above.
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EXHIBIT 99.1
FOR ADDITIONAL INFORMATION:
Corporate Communications, Cygnus
(650) 369-4300 www.cygn.com
Burns McClellan (212) 213-0006
Justin Jackson - Media
FOR IMMEDIATE RELEASE
Cygnus' GlucoWatch (Registered Trademark) To Be Reviewed
By FDA Panel December 6, 1999
Redwood City, Ca. - October 27, 1999 - Cygnus, Inc. (Nasdaq: CYGN) today
announced that the United States Food and Drug Administration (FDA) has
scheduled December 6, 1999 as the date for an advisory committee review of
Cygnus' premarket approval application (PMA) for their GlucoWatch (Registered
Trademark) monitor, an investigational device intended to provide frequent,
automatic and non-invasive monitoring of glucose levels for adults with
diabetes. The meeting will be held with the Clinical Chemistry and Clinical
Toxicology Devices Panel of the Medical Devices Advisory Committee.
"We are very excited to have a date scheduled for this panel meeting just five
months from the FDA's filing of our extensive premarket approval application,"
stated John C. Hodgman, Chairman, President and Chief Executive Officer of
Cygnus. "We've been consulting regularly with the FDA regarding the
application for our GlucoWatch (Registered Trademark) monitor, and look
forward to this upcoming advisory panel meeting," Mr. Hodgman added.
In July 1999 the FDA notified Cygnus that its PMA application was deemed
suitable for filing and was granted expedited review status. Cygnus'
5,000-page PMA application included analyses of clinical studies conducted on
more than 600 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. Although the FDA is not bound by
the decisions of the advisory committee, the agency typically follows its
advisory committees' advice.
The GlucoWatch (Registered Trademark) monitor is intended for detecting trends
and tracking patterns in glucose levels in adults, 18 years and older, who
have diabetes. This device is intended for use by patients at home and in
health care facilities. 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. The GlucoWatch (Registred Trademark) monitor could be used during
one's normal daily routine at home and at work and even while sleeping. The
frequent readings provided by the GlucoWatch (Registered Trademark) monitor
have the potential to help manage diabetes better. The GlucoWatch (Registered
Trademark) monitor has the capability to alert users when glucose levels are
too high or too low. These situations may be hard to identify with regular
glucose testing alone. The GlucoWatch (Registred Trademark) monitor is
indicated for use in the detection and assessment of episodes of hyperglycemia
and hypoglycemia, facilitating both acute and long-term therapy adjustments,
which may minimize these excursions.
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.
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 panel meeting will result in a recommendation for approval
to the FDA. There can be no assurances that a recommendation for approval from
the advisory committee would result in a clearance from the FDA to market the
device. Also, there can be no assurances that if the Company receives
marketing clearance from the FDA that the product could be successfully
manufactured or marketed. 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
