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Biotech / Medical : CYGN -- Ignore unavailable to you. Want to Upgrade?

To: Bhag Karamchandani who wrote (37)	10/29/1999 1:02:00 PM
From: Alastair McIntosh	Read Replies (1) \| Respond to of 135

This may be of interest: cygn.com Cygnus GlucoWatch® Monitor To Be Reviewed By FDA Panel December 6, 1999 Redwood City, CA - October 27, 1999 - Cygnus, Inc (Nasdaq:CYGN) today announced that the United States Food and Drug Administration (FDA) has scheduled December 6, 1999 as the date for an advisory committee review of Cygnus' premarket approval application (PMA) for their GlucoWatch® monitor, an investigational device intended to provide frequent, automatic and non-invasive monitoring of glucose levels for adults with diabetes. The meeting will be held with the Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee. "We are very excited to have a date scheduled for this panel meeting just five months from the FDA's filing of our extensive premarket approval application," stated John C. Hodgman, Chairman, President and Chief Executive Officer of Cygnus. "We've been consulting regularly with the FDA regarding the application for our GlucoWatch® monitor, and look forward to this upcoming advisory panel meeting," Mr. Hodgman added. In July 1999 the FDA notified Cygnus that its PMA application was deemed suitable for filing and was granted expedited review status. Cygnus' 5,000-page PMA application included analyses of clinical studies conducted on more than 600 people with diabetes, who used the device for up to six weeks. The studies, which were performed at more than 15 clinical sites across the United States, involved over 25,000 hours of use of the GlucoWatch® monitor. The participants consisted of a cross-section of racial and age groups, diabetes types (both type 1 and type 2), and other defining characteristics. Approximately 19,000 paired data points were generated from the studies, comparing glucose measurements obtained by the GlucoWatch® monitor to glucose measurements obtained with finger-stick monitors using capillary blood. Although the FDA is not bound by the decisions of the advisory committee, the agency typically follows its advisory committees' advice. Al