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[IP] Fwd: Cygnus Launches GlucoWatch® Biographer in U.S.
Date: Mon, 15 Apr 2002 08:37:12 -0400
This News Release will be posted on Cygnus' website at
http://www.cygn.com/press/news.html as soon as possible after it is released
to the media.
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For additional information, please contact Cygnus by phone at (650)
369-4300, fax at (650) 599-2503 or visit our homepage at: www.cygn.com.
Cygnus Launches GlucoWatch(R) Biographer in U.S.
The only FDA-approved product that provides
frequent, automatic and non-invasive measurement of glucose levels
Redwood City, CA - April 15, 2002 - Cygnus, Inc. (Nasdaq: CYGN) today
announced the U.S. market launch of the GlucoWatch(R) Biographer, the only
product approved by the U.S. Food and Drug Administration (FDA) for
consumers designed to measure glucose levels frequently, automatically and
non-invasively. The frequent and automatic measurements provided by the
GlucoWatch Biographer can identify trends and track patterns in fluctuating
glucose levels that would be difficult for people with diabetes and their
health care teams to detect with current testing techniques alone.
"We are very excited about making the GlucoWatch Biographer available in the
United States. It represents the most significant technological
breakthrough in glucose monitoring since the transition from urine dip
sticks to blood meters about twenty years ago. Numerous clinical studies
have demonstrated the health benefits of frequent glucose testing and more
frequent insulin injections. Unfortunately, the vast majority of people
with diabetes do not test their glucose levels frequently enough and
fluctuating glucose levels make it extremely difficult for detection with
current testing methods alone," stated John C Hodgman, Chairman, Chief
Executive Officer and President of Cygnus, Inc. "There is an unmet need for
a product that can readily provide frequent glucose measurements. The
GlucoWatch Biographer can be the solution for millions of people with
The GlucoWatch Biographer is the first and only glucose monitoring system
that provides readings frequently, automatically and non-invasively, up to
three times an hour, for up to twelve hours day or night. The Biographer is
a glucose monitoring device designed to detect trends and track patterns in
glucose levels in adults (ages 18 and older) with diabetes. This device is
intended for use by patients at home and in health care facilities. It is
for prescription use only. The Biographer is intended for use an adjunctive
device to supplement, not replace, information obtained from standard home
glucose monitoring devices. The GlucoWatch Biographer is indicated for use
in detection and assessment of episodes of hyperglycemia and hypoglycemia,
facilitating both acute and long-term therapy adjustments, which may
minimize these excursions. Interpretation of Biographer results should be
based on the trends and patterns seen within several sequential readings
The GlucoWatch Biographer differs from other glucose monitoring systems in
several ways. It is non-invasive, collecting glucose through the skin, not
from blood. It automatically measures and displays glucose levels and
detects trends and patterns in glucose levels as opposed to a single,
discrete reading. It has alert systems to inform users when glucose levels
are too high, too low or declining rapidly. The Biographer also stores up
to 4,000 glucose values in an electronic diary that can be reviewed at the
touch of a button or uploaded into a software program to enable detailed
analysis of glucose fluctuations.
"The GlucoWatch Biographer represents a tremendous advance in diabetes
management," said Steven Edelman, M.D., Professor of Medicine, Division of
Diabetes and Metabolism, University of California San Diego School of
Medicine and Veterans Affairs, and the founder and Director of the
non-profit organization Taking Control of Your DiabetesTM. "Most people
with diabetes are not fully aware of the frequent fluctuations they have in
their glucose levels. I have many patients who will benefit greatly from
the insight they will gain from the additional information provided by the
Biographer," added Dr. Edelman.
The GlucoWatch Biographer will be available for sale through direct mail,
not through retail pharmacies. People interested in learning more about the
GlucoWatch Biographer and how to order can request information by calling
toll free 1-866-GLWATCH (1-866-459-2824) or by visiting www.glucowatch.com.
To obtain a GlucoWatch Biographer, adults with diabetes will need to consult
a health care professional to get a prescription, complete the order form
contained in the Introductory Training Brochure and complete a questionnaire
to be sure the device is right for them.
The GlucoWatch Biographer consists of two main parts: the durable
Biographer, which is the watch-like device that attaches to a person's
forearm, and the AutoSensor, the disposable component that attaches to the
back of the Biographer and allows for glucose monitoring for up to 12 hours.
The price of the Starter Kit, which includes the GlucoWatch Biographer,
instructional video, user guide, battery charger and two rechargeable
batteries, as well as other accessories, is $595. AutoSensors are sold in
cartons of 16 and sell for $69.75. Also available for sale at $35.00 is the
GlucoWatch(R) Analyzer, FDA-approved software that downloads data retrieved
by the individual's Biographer into a personal computer for display and
storage of data. The software uses the data to generate statistical reports
and graphs that are designed to create a comprehensive picture of an
individual's recent glucose level history and allow for analysis of trends
and patterns in glucose levels. Purchases can only be made by using VISA(R)
or MasterCard(R) credit cards. At the completion of the transaction, the
GlucoWatch Biographer and associated products will be shipped directly to
Cygnus and Sankyo have been collaborating closely on sales and marketing
efforts under an agreement signed in November 2001. The co-promotion
agreement covers the GlucoWatch Biographer and other similar glucose
monitoring products in the United States. The agreement calls for Sankyo to
provide a 50-person specialty sales force, well-versed in diabetes and its
treatment, to leverage Sankyo's already established relationships with
physicians having the highest potential for prescribing the GlucoWatch
Biographer. Sankyo may also provide broad market coverage through their 450
primary care sales representatives. In addition, Sankyo may deploy 20
managed care account managers to obtain insurance reimbursement for the
GlucoWatch Biographer and 20 medical managers who would communicate key
scientific data to medical professionals.
The World Health Organization estimates there are 125 million people
worldwide with diabetes. This number has increased 15% in the last 10 years
and is expected to double by 2025. In the United States, approximately 10
million Americans have been diagnosed with diabetes and each year
approximately 13,000 children are diagnosed. Diabetes is a leading cause of
death in the United States, and the complications of uncontrolled diabetes
result in an estimated $100 billion in medical costs annually. The current
worldwide market for glucose measuring products is estimated at between $3
billion and $4 billion, and it is expected to exceed $4.7 billion in 2002.
The United States is estimated to account for 50%-60% of all sales, while
Western Europe accounts for approximately 30% of sales.
Cygnus, Inc. is engaged in the development and manufacture of diagnostic
medical devices, utilizing proprietary technologies to satisfy unmet medical
needs cost-effectively. The first such device is a frequent, automatic and
non-invasive glucose monitoring device, the first-generation GlucoWatch
Biographer. A supplemental pre-market approval (PMA) submission is currently
under expedited review by the FDA for use of the GlucoWatch Biographer by
children and adolescents (ages 7-17). The GlucoWatch Biographer has also
received the CE mark permitting sales in the European Union, and Cygnus is
currently selling the first-generation product in the United Kingdom.
Sankyo Pharma Inc. is a wholly owned subsidiary of Sankyo Co. Ltd., the
second largest drug company in Japan. Sankyo is a recognized research-based
company and a source of new therapeutic agents, including drugs for
cardiovascular disease and diabetes.
More information about Cygnus can be found at the corporate web site:
http://www.cygn.com. Additional information about the GlucoWatch Biographer
can be obtained by calling the Company's toll-free number, 1-866-GLWATCH, or
by visiting http://www.glucowatch.com.
Some of the statements in this news release are forward-looking statements
that involve risks and uncertainties. These forward-looking statements
include statements about the Company's plans, objectives, expectations,
intentions and assumptions and other statements contained in this news
release that are not statements of historical fact. Forward-looking
statements include, but are not limited to, statements about the Company's
ability to manufacture and scale-up commercially the GlucoWatch Biographer,
the Company's plans for commercialization alliances, the Company's ability
to achieve market acceptance of the GlucoWatch Biographer, and the Company's
plans for enhancements and possible manufacturing changes through the
regulatory process. In some cases, you can identify these statements by
words such as "may," "will," "should," "estimates," "predicts," "potential,"
"continues," "strategy," "believes," "anticipates," "plans," "expects,"
"intends" and similar expressions. Cygnus cannot guarantee future results,
levels of activity, performance or achievements. Actual results and the
timing of certain events may differ significantly from the results discussed
in the forward-looking statements. 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. "GlucoWatch" is a
registered trademark of Cygnus, Inc.
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