Cygnus, CYGN Diabetes-Glucowatcher genehmigt ! - 500 Beiträge pro Seite

[sittin bull inv]

Diese Woche kam endlich die lang ersehnte Nachricht
aus den USA.
Aktie ging daraufhin 40 % hoch!
Zug noch nicht abgefahren!


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Thursday March 22, 10:45 am Eastern Time

Press Release

SOURCE: Cygnus, Inc.

FDA Approves Cygnus` GlucoWatch(R) Biographer;
Company Readies For Product Launch

First Non-Invasive, Automatic Glucose Monitoring System For
People with Diabetes

REDWOOD CITY, Calif., March 22 /PRNewswire/ -- The U.S. Food and Drug
Administration (FDA) has granted Cygnus, Inc. (Nasdaq: CYGN - news) approval to
market its GlucoWatch® Biographer as a prescription device for adults with diabetes.
The GlucoWatch Biographer is the first and only monitoring system that provides glucose
readings automatically and non-invasively, up to three times an hour, day or night.

``We are very excited about moving closer to bringing this important new technology to
people with diabetes who may benefit from having more information about their glucose
levels,`` noted John C Hodgman, Chairman, CEO and President of Cygnus. ``Cygnus is
continuing efforts toward establishing capabilities to distribute and support the
GlucoWatch Biographer in select worldwide markets, including the United States and
Europe,`` added Hodgman.

The GlucoWatch Biographer uses technology that has never been available before,
differing from conventional blood glucose testing devices in several ways. Most
significantly, it is non-invasive, measuring glucose collected through the skin, not from
blood. It measures and displays glucose levels automatically, 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 works by using an extremely low electric current to pull
glucose through the skin. The glucose is then collected and transformed into an electric
signal that is converted into a glucose reading. The system consists of two integrated
parts, the Biographer and the AutoSensor. The Biographer is worn like a watch and
calculates, displays and stores glucose readings. The AutoSensor is a single-use
component that first collects and then measures the glucose sample. The AutoSensor
snaps into the back of the Biographer and adheres to the skin, providing up to twelve
hours of automatic readings.

Experts agree that many people with diabetes should test their glucose levels as often as 4-7 times a day. However, due to
the pain and inconvenience of current testing methods, many people with diabetes perform just a few tests each day; for
example, right before meals. This means they possibly miss revealing information about glucose levels at other important
times, such as after meals or during sleep. With the GlucoWatch Biographer, people with diabetes will have access to the
type of information that may help them make better-informed decisions about diet, medication and physical activities. This
may eventually lead to a better quality of life and lower health care costs. The GlucoWatch Biographer is not intended to
replace the common ``finger-stick`` testing method, but rather is designed to be used together with blood glucose testing to
provide more complete, ongoing information about glucose levels.

During March 2001, Cygnus announced that it had entered into an agreement with Lifescan, a Johnson & Johnson
company, related to Cygnus` planned marketing research. And in preparation for the U.S. launch, Cygnus has contracted
with Livingston Healthcare Services, Inc., a recognized leader in logistics and supply chain management, who will provide a
variety of services, including order entry, warehousing, direct-to-customer shipping and customer support functions.
``Cygnus will also continue to explore opportunities for commercialization alliances with other companies,`` said Craig W.
Carlson, CFO and Senior VP, Finance at Cygnus. ``And before we launch the product in the U.S., we must ensure that
product supplies are adequate to meet the expected strong demand. Therefore, we are finalizing a large-scale manufacturing
process for the consumable AutoSensors, and we will complete all related regulatory submissions,`` said Carlson.

Cygnus has already received initial certification (i.e., the ``CE Mark``) to market the GlucoWatch Biographer in Europe, and
began controlled marketing in the United Kingdom in 2000 to assess patient usage experiences and fine-tune education
programs and customer support before making the device more widely available there later this year. Introduction into
additional European markets is anticipated in 2001.

Cygnus will conduct a pilot marketing program in the U.S. to learn more about patients` and caregivers` firsthand
experiences with the product. To support that effort, comprehensive training materials and curricula have been developed
and will be introduced to physicians and health care professionals. In addition, new clinical research trials will be started,
focusing on various patient groups, including adolescents and pregnant women. The Company will also conduct outcome
studies designed to demonstrate the clinical benefits of the GlucoWatch Biographer, collecting data needed to secure
reimbursement from managed care organizations.

Diabetes is a chronic disease characterized by the body`s inability to produce or properly use insulin, a hormone that is
needed to convert sugar, starches and other food into the energy needed for daily life. When left untreated, diabetes can
lead to heart disease, blindness, amputation, kidney disease, dental disease, nerve damage, sexual dysfunction and
pregnancy complications.

The World Health Organization 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. 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%.

Cygnus, Inc., headquartered in Redwood City, California, develops and manufactures non-invasive diagnostic medical
devices, utilizing proprietary biosensor technologies to satisfy unmet medical needs cost-effectively. The Company`s current
efforts are focused on the GlucoWatch Biographer and enhancements thereto.

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.

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. There can be no
assurance that unforeseen problems will not occur in product manufacturing and commercial scale-up or marketing or
product distribution of the GlucoWatch Biographer or that regulatory approval will be received for large-scale manufacturing
processes. Any such occurrence could significantly delay the commercialization of the GlucoWatch Biographer system or
prevent its market introduction entirely. Further, 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 the product can be
successfully manufactured in commercial quantities at a reasonable cost, be marketed successfully or achieve market
acceptance. Furthermore, as the Company seeks regulatory approval for enhancements and possible manufacturing changes
through the pre-market approval (PMA) supplement process, there can be no assurance that such supplements will be
approved or that one or more new PMAs will not need to be filed. 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.

SOURCE: Cygnus, Inc.


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Sittin...

[sittin bull inv]

von Redaktion WO [W:O] 09.05.00 22:25:24 906872
Der Hersteller von medizinischen Geräten Cygnus Inc. (Nasdaq: CYGN) fällt heute um 10 % auf 12 US-Dollar zurück.

Grund ist die Aussage, deren hoffnungsreichste Produkt, GlucoWatch, erst zum Ende diesen Jahres oder sogar erst zu Beginn
des nächsten Jahres auf den Markt bringen zu wollen. GlucoWatch ist ein am Handgelenk getragenes Instrument zur Messung
des Blutzuckergehalts für Diabetiker. Dies geschieht völlig extern, es ist also kein Hauteinschnitt nötig. Das Gerät nutzt niedrige
elektronische Ströme, um Flüssigkeiten direkt unter der Haut zu beschreiben und so den Zuckergehalt im Blut zu messen.

Nach der Aussage von Cygnus hat die amerikanische Food and Drug Administration (FDA) einen sogenannten „approvable
letter“ für GlucoWatch herausgegeben. Dies bedeutet, dass die FDA den Vermarktungsantrag und andere Beratungsberichte
bereits überprüft hat, und auch glaubt, das Produkt für die Vermarktung frei geben zu können. Es müssen aber noch bestimmte
finale Kriterien erfüllt werden. Dazu gehören Überprüfungen der Produktperformance, der Herstellung und der Vermarktung.

Erhält man die vollständige Genehmigung will man zuerst 10-15 Ärzten den GlucoWatch zur Verfügung stellen, bis zum Ende
des Jahres dann eine breite Markteinführung in Betracht kommt.

[sittin bull inv]

Web-Seite:

http://www.cygn.com

[xanda1]

cygn hatte in 2000 1 mio us$ umsatz.
kapitalisierung = 164 mio us$.
kein investment für mich!

[sittin bull inv]

Ja, kalt erwischt.

Sie haben aber auch erst jetzt die Genehmigung bekommen,
ihr Hauptpatent kommerziell zu nutzen.


Man muß einfach von der Praktiktischen Seite ausgehen...

Ist es für Zuckerkranke nicht wesentlich einfacher,
statt sich selbst ständig zu überwachen und Spritzen zu setzen,
einfach am Handgelenk diesen Watcher zu tragen,
der den Zuckerspiegel selbst regelt.


Wenn ja, wie viel Marktpotenzial ist vorhanden?


Bestimmt mehr als 160 Mio $.


Habe selbst nur kleine Position...