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SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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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) May 9, 2000
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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 File (IRS Employer
of incorporation) 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 May 9, 2000, Cygnus, Inc. issued a press release, the text of which
is attached hereto as Exhibit 99.1, announcing that the Company received an
approvable letter on May 8, 2000 from the U.S. Food and Drug Administration
(FDA) for Cygnus' GlucoWatch-registered trademark- biographer. The Company
also announced that pending FDA approval, the company anticipates introducing
the GlucoWatch biographer on a limited basis, via 10 to 15 physicians
primarily in the San Francisco Bay Area.
ITEM 7. FINANCIAL STATEMENTS AND EXHIBITS.
(c) Exhibits.
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Exhibit Number
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<S> <C>
99.1 Press Release by Cygnus, Inc. dated May 9, 2000 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: May 17, 2000 By: /s/ Barbara G. McClung
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Barbara G. McClung
Senior Vice President
and General Counsel
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EXHIBIT 99.1
FOR ADDITIONAL INFORMATION:
Corporate Communications, Cygnus, Inc.
(650) 369-4300 www.cygn.com
Justin Jackson or Naomi Novak -- Media
Burns McClellan -- (212) 213-0006
FOR IMMEDIATE RELEASE
CYGNUS, INC. RECEIVES APPROVABLE LETTER FROM U.S. FDA
FOR ITS GLUCOWATCH-registered trademark- BIOGRAPHER
REDWOOD CITY, CA -- MAY 9, 2000 -- Cygnus, Inc. (Nasdaq: CYGN) received an
approvable letter on May 8, 2000 from the U.S. Food and Drug Administration
(FDA) for Cygnus' GlucoWatch-registered trademark- biographer. The GlucoWatch
biographer is the only glucose monitoring system that allows adults with
diabetes to check their glucose levels, automatically and non-invasively, up
to three times an hour, day or night.
An approvable letter means that the FDA has reviewed the Company's pre-market
approval (PMA) application, as well as its own Advisory Committee's report
and recommendation, and that the FDA believes it will approve the
application, pending specific final conditions. The conditions stated relate
to post-market evaluations of certain aspects of product performance,
manufacturing, and final printed labeling materials.
"We are very excited to receive this approvable letter and will work with
the FDA to address the necessary follow-up items," stated John C Hodgman,
Chairman, Chief Executive Officer, and President of Cygnus, Inc. "Pending
FDA approval, we anticipate introducing the GlucoWatch biographer on a
limited basis, via 10 to 15 physicians primarily in the San Francisco Bay
Area. A broader product introduction is anticipated toward the end of this
year or early next year."
The FDA's Clinical Chemistry and Clinical Toxicology Devices Panel of the
Medical Devices Advisory Committee unanimously recommended approval of the
GlucoWatch biographer on December 6, 1999.
The GlucoWatch system is a frequent, automatic, and non-invasive glucose
monitoring device in the form of a wrist watch. After a three-hour warm-up,
measurements are automatically and non-invasively taken up to thirty-six
times over twelve hours (every twenty minutes), with just one finger-stick
measurement for calibration. Other features include alarms that can be set to
detect high, low, and rapidly declining glucose levels, and a memory that can
store the equivalent of three months of glucose measurements. The GlucoWatch
system is designed to detect trends and track patterns in glucose levels in
those eighteen years and older who have diabetes. Intended for use at home
and in healthcare facilities, the device is meant to supplement, not replace,
information obtained from standard home blood glucose monitoring devices.
Cygnus, Inc., headquartered in Redwood City, California, develops and
manufactures 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 system) and enhancements thereto.
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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 SYSTEM. FURTHER, THERE
CAN BE NO ASSURANCE THAT THIS 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. 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
