FDA grants marketing approval:
>>REDWOOD CITY, CA, Mar 22, 2001 (INTERNET WIRE via COMTEX) -- The U.S. Food and Drug Administration (FDA) has granted Cygnus, Inc. (Nasdaq: CYGN chart, msgs) approval to market its GlucoWatch(R) 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 believe the GlucoWatch Biographer will usher in a new era of glucose monitoring and thus improved ability for patients and their doctors to manage diabetes," noted John C Hodgman, Chairman, CEO and President of Cygnus, Inc. "We are very excited that the FDA has granted marketing approval for our new product. This major milestone brings the Biographer closer to being available to provide important information about glucose levels to people with diabetes. The next steps prior to a broad launch in the U.S. will include a pilot marketing program and the finalization of large-scale manufacturing capabilities to meet projected demand."
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 uses 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.
The GlucoWatch Biographer is not intended to replace the common "finger-stick" testing method, but rather to be used together with blood glucose testing to provide more complete, ongoing information about glucose levels. For example, many people with diabetes perform only a few finger-stick tests each day, possibly missing information about glucose levels at important times, such as after meals or during sleep. With the GlucoWatch Biographer, people with diabetes will have information that may help them make better-informed decisions about diet, medication and physical activities, possibly leading to lower health care costs and a better quality of life.
"As a physician, and a person with diabetes, I know the importance of having as much information about glucose levels as possible," said Steven Edelman, M.D., Associate Professor of Medicine, Division of Diabetes and Metabolism, University of California San Diego School of Medicine and Veterans Affairs Medical Center, and founder of the non-profit organization Taking Control of Your Diabetes(TM). "I have used the GlucoWatch Biographer myself, as a participant in a clinical study, and I experienced its value as an important new tool. In addition to providing more information about glucose levels than we've ever had before, the GlucoWatch Biographer's built-in alert system can help identify potentially dangerous low blood sugar episodes; for example, at night or while driving."
Cygnus' pilot marketing program will mark the first time that U.S. patients will use the GlucoWatch Biographer outside of controlled clinical studies. The program is intended to gather valuable market research data and to test customer logistics and support functions. During March 2001, Cygnus announced that it had entered into a marketing research agreement with Lifescan, a Johnson & Johnson company, related to the information collected in the program.
In addition to conducting the pilot program, Cygnus will finalize a large-scale manufacturing process for the consumable AutoSensors, submit all related regulatory applications for that process, and seek corresponding FDA approvals. The large-scale capability is required to meet the demand that is anticipated after the U.S. product launch.<<
snip Emphasis mine.
I'll take Dr. Edelman's opinion of its worth over yours, thanks.
Cheers, Tuck |
