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[IP] FDA Panel Gives Its Approval

here's the news!

FDA Panel Gives Its Approval
 To MiniMed's Glucose Monitor

 Dow Jones Newswires

 WASHINGTON -- A new type of glucose monitor by MiniMed Inc. won
 the recommendation of a federal advisory panel, with certain conditions.

 On Friday, the panel recommended the Food and Drug Administration
 approve MiniMed's continuous glucose monitoring system, which could
 dramatically improve how doctors care for diabetics. The FDA will make the
 final decision on the device, although it usually clears drugs or devices
 by its expert panels.

 The monitor system includes a sensor, which is implanted just below the
 and into the tissue of the patient's abdomen. The sensor checks glucose
 five minutes and sends the information to a pager-like monitor.

 After three days of gathering information, the patient returns to the
 who will download the glucose information to a computer. The information
 isn't displayed for the patient.

 Dr. John Mastrototaro, MiniMed's senior director for sensor development
 and manufacturing, said the monitor will help gather trends.

 The monitor isn't meant to replace the regular finger-stick regimen, which
 for diabetics to prick their finger to check blood sugar levels several
 daily, Dr. Mastrototaro said.

 "This will supplement standard glucose monitoring," Dr. Mastrototaro said,
 because the monitor will provide 288 readings each day, compared with the
 finger-stick, which is taken about every six hours.

 Physicians can identify patterns, which could lead to modification of
 he told the panel.

 Dr. Todd Gross, MiniMed's manager of corporate statistics, told the panel
 that the company's studies involved about 60 insulin-dependent patients
 five to 10 sensors implanted in each patient, although for commercial use
 one sensor at a time will be necessary.

 During the total 1,153 days the sensors were used only seven mild to
 moderate adverse events were reported. The side effects included
 minor bleeding, bruising and discomfort, Dr. Gross said.

 To complete the application MiniMed submitted to the FDA, the agency
 asked the company to conduct a simulated patient study. For the simulation,
 the sensor was placed in beakers with a glucose solution. The company
 changed the sugar levels constantly and recorded the accuracy of the
 "There was excellent agreement," Dr. Mastrototaro said. "It confirms the
 sensor provides an accurate profile."

 Dr. Alan Marcus, a MiniMed medical consultant and associate professor at
 the University of Southern California, said the monitor system offers a
 detailed look at a patient's sugar levels.

 Dr. Marcus told the panel the monitor would be helpful occasionally to help
 patients realize when their glucose levels are fluctuating widely. Also,
for new
 patients, the system could be used to help determine when they should check
 their glucose with finger sticks.

 The panel also heard the FDA's analysis of MiniMed's data. The device uses
 "groundbreaking technology," said Dr. Steven I. Gutman, director of FDA's
 Division of Clinical Laboratory Devices in the Office of Device Evaluation.

 John Dawson, an FDA statistician, said in reviewing MiniMed's data, the
 monitor's information agreed with other glucose readers 88% of the time.

 Dr. Gerald Bernstein, president of the American Diabetes Association, said
 device like MiniMed's could improve the standard of living for people with
 diabetes. Because the monitor will help adjust therapy to better manage
 patient's glucose levels, Dr. Bernstein said patients may function better.

 "People whose glucose levels are better controlled have a better quality of
 life," said Dr. Bernstein, who is also director of the diabetes management
 program at Beth Israel in New York. "It could help prevent complications
 help people function better."

 If approved, Dr. Berstein said the first group of diabetics that will
 benefit from MiniMed's monitor are the one million Americans with type 1
 diabetes, who are insulin dependent.

 As the technology advances, Dr. Bernstein projects use of the monitor will
 increase when patients can use it read their glucose levels. "In its
current form,
 its use is modestly limited," Dr. Bernstein said. "As it evolves, it will
 possibly universal. Many people hate sticking their fingers," he said.

 The FDA panel unanimously backed MiniMed's monitor system. All members
 said additional studies were needed. However, group members disagreed on
 whether more trials should be conducted before or after the device is
 available on the market.

 Panelist Dr. James Everett, medical director of the family medicine
 department at Morehouse School of Medicine in Atlanta, said before the
 monitor is approved, MiniMed should look at a more diverse group of
 patients. Of the patient's MiniMed studied all were Caucasian, except for
 three African-Americans and one Asian.

 Panelist Dr. Steven Clement, director of the Georgetown Diabetes Center
 here, agreed with Dr. Everett that additional groups need to be studied
 to approval and he said gathering additional information should be helpful

 Other panelists said additional studies on diabetic children and patients
 other complications should be conducted after the product is on the market.

 About 16 million people in the U.S. suffer from diabetes. Most American
 diabetics have the type 2 form of the disease. Approximately one million
 diabetics have type 1 diabetes, which causes them to rely on insulin.

 Diabetes occurs when the body can't regulate its glucose. Patients
 have elevated sugar levels resulting from decreased insulin, which is
 by the pancreas.

 ING Barings analyst Kevin Kotler said if the FDA agrees with the panel and
 approves MiniMed's device, sales could reach $65 million by 2001. That
 projection, Mr. Kotler said, assumes MiniMed would have the next
 generation of the device on the market, which would allow patients to read
 glucose levels using the system.

Kelly L. Shaughnessy
Merrill Lynch Fundamental Equity Research
(415) 274-8294
(415) 274-8255 (fax)

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