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[IP] FDA Approval Received for GlucoWatch® Biographer Manufacture at Cygnus
Hopefully they are making some real progress on this.
>From: email @ redacted
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>Date: Thu, 01 Nov 2001 08:06:41 -0500
>Subject: FDA Approval Received for GlucoWatch. Biographer Manufacture at
>This News Release is posted on Cygnus' website at:
>Please note: This email service is intended solely to distribute
>information, and is not designed to be an interactive email system. Please
>note that replies to Cygnus' email announcement will not be responded to.
>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.
>FDA Approval Received for GlucoWatch(R) Biographer Manufacture at Cygnus
>Redwood City, CA -November 1, 2001 - Cygnus, Inc. (Nasdaq: CYGN) today
>announced that it received approval from the U.S. Food and Drug
>Administration (FDA) for Cygnus to perform the final assembly of the
>durable component of the GlucoWatch(R) Biographer system. Several weeks
>ago, Cygnus received FDA approval for the large-scale production site and
>process for AutoSensors, the consumable component of the GlucoWatch
>"With the recent FDA approvals of all outstanding manufacturing pre-market
>approval (PMA) supplements, the key elements for launching the GlucoWatch
>Biographer in the U.S. are falling into place," stated John C Hodgman,
>Chairman, CEO and President of Cygnus, Inc. "The distribution and
>customer support functions are ready, as are the educational, training and
>promotional materials for people with diabetes and health care
>professionals. In addition, we are currently in advanced stages of
>negotiation with multiple companies for a sales alliance. We anticipate
>the first sales in the U.S. during the first quarter of 2002."
>The FDA submission for final Biographer assembly at Cygnus was made on
>August 27, 2001. Cygnus originally contracted with another company to
>manufacture certain components and then perform the final assembly of the
>Biographer. In order to reduce cost and increase capacity, Cygnus
>subsequently decided to perform final assembly of the Biographer itself.
>The World Health Organization (WHO) estimates there are 125 million people
>worldwide with diabetes. This number has increased 15% in the last ten
>years and is expected to double by 2005. In the U.S., approximately ten
>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
>U.S., 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 and $4 billion, and it is expected to
>exceed $4.7 billion by 2002. The U.S. is estimated to account for 50-60%
>of all sales, while Western Europe accounts for approximately 30%.
>The GlucoWatch Biographer differs from conventional blood glucose testing
>devices in several ways. It automatically and non-invasively measures
>glucose collected through the skin, not from blood, and displays glucose
>levels as often as every twenty minutes, for up to twelve hours. It also
>creates an "electronic diary," storing up to 4,000 values that can be
>reviewed at the touch of a button, helping to detect trends and track
>patterns in glucose levels. In addition, users can set personal glucose
>alert levels so that an alarm sounds if readings are too high or too low,
>or if readings decline rapidly. The GlucoWatch Biographer is not intended
>to replace the common "finger-stick" testing method, but is indicated as
>an adjunctive device to supplement blood glucose testing to provide more
>complete, ongoing information about glucose levels.
>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 GlucoWatch
>Biographer. The GlucoWatch Biographer is approved in the United States as
>a prescription device for adults (18 years and older). An additional PMA
>submission is currently under review by the FDA for the use of the
>GlucoWatch Biographer by children and adolescents (ages 7-17). As
>previously indicated by Cygnus, post-market evaluation studies are
>required on certain topics after commercialization. The GlucoWatch
>Biographer has also received the CE mark permitting sales in the European
>Union and Cygnus is currently selling the product in the United Kingdom.
>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
>and AutoSensor, plans for commercialization alliances, the Company's
>ability to achieve market acceptance of the GlucoWatch Biographer, and
>plans for future products. In some cases, you can identify these
>statements by words such as "may," "will," "should," "estimates,"
>"predicts," "potential," "continue," "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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