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[IP] Cygnus Receives Approvable Letter from US FDA

Cygnus, Inc. Receives Approvable Letter From U.S. FDA for Its GlucoWatch(R) 

REDWOOD CITY, Calif., May 9 /PRNewswire/ -- Cygnus, Inc. (Nasdaq: CYGN) 
received an approvable letter on May 8, 2000 from the U.S. Food and Drug 
Administration (FDA) for Cygnus' GlucoWatch(R) 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 

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.

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.

SOURCE  Cygnus, Inc.

CO:  Cygnus, Inc.; U.S. Food and Drug Administration

ST:  California



05/09/2000 06:55 EDT http://www.prnewswire.com
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