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[IP] Glucowatch Timeline

     FYI- based on the FDA submission, I would expect the Glucowatch could 
     get FDA approval in 6-9 months.  I don't know how long after that they 
     would actually start marketing it.
     -David W.
     Cygnus Plans June 1999 Submission to the FDA for Marketing Approval 
     Of the GlucoWatch(R) Monitor for People With Diabetes 
     Manufacturing Documentation to Be Submitted Before the End of February 
     REDWOOD CITY, Calif., Jan. 7 /PRNewswire/ -- Cygnus, Inc. (Nasdaq: 
     CYGN) announced today that, following conversations with the
     Food & Drug Administration (FDA), the company intends to submit a 
     Pre-Market Approval Application (PMA) by June 1999 for the
     GlucoWatch monitor for adults with diabetes. The product PMA will 
     include analysis of a recently completed series of clinical studies
     totaling more than 500 people, for which over 20,000 data points were 
     generated, as well as two additional studies with approximately 30
     people per study. The two additional, minor studies will be initiated 
     later this quarter and are intended to address potential data requests
     which could arise at a panel meeting. An FDA-approved IDE 
     (Investigational Device Exemption) will not be required for these two 
     studies.  The FDA has indicated this application is appropriate for an 
     expedited review. 
     "We are very pleased with the FDA's encouraging and productive 
     approach to review the GlucoWatch system," stated John Hodgman,
     president and CEO of Cygnus, Inc. "The clock is now set for submission 
     of the current clinical results, as well as data from two
     additional, smaller studies. Pursuant to completing the entire 
     marketing application before the end of the second quarter, we 
     anticipate first submitting manufacturing documentation by the end of 
     February. We believe that both deadlines are realistic, based on 
     feedback from the FDA this past December." 
     The recently completed clinical studies were conducted in three 
     different settings: a laboratory environment under strict supervision, 
     a home-simulated environment and a normal home usage environment. The 
     studies were conducted on adults of differing ages, ethnic
     backgrounds and physiological factors. Glucose measurements using the 
     GlucoWatch monitor and blood measurements were taken
     frequently over a 12 hour period. These measurements are being 
     analyzed using a variety of statistical techniques. The accuracy of 
     the GlucoWatch monitor will be evaluated using these statistical 
     The GlucoWatch monitor is designed to take frequent measurements, thus 
     providing an abundance of glucose data to potentially better
     control fluctuating glucose levels. The product uses reverse 
     iontophoresis to non-invasively extract and measure glucose levels. 
     After calibrating with a standard blood glucose monitor, which can 
     occur 3 hours after putting on the GlucoWatch monitor, the watch will
     automatically and non-invasively take up to three measurements an hour 
     for 12 hours. Each AutoSensor (the disposable component) will
     provide 12 hours of measurements. The GlucoWatch monitor has a variety 
     of features, which include the capability to sound an alert if
     glucose levels get too high or too low, to store data for three 
     months, and to download past glucose data into a PC. 
     Cygnus is engaged in the development and manufacture of diagnostic and 
     drug delivery systems utilizing its proprietary technologies to
     satisfy unmet medical needs cost effectively. Cygnus' current efforts 
     are primarily focused on two core areas: an automatic and
     continuous glucose monitoring device (the GlucoWatch monitor) and 
     transdermal drug delivery systems. 
Insulin-Pumpers website http://www.insulin-pumpers.org/