I was checking out the link to childrenswithdiabeties that was in that release. There was some discussion of these rumored continuous glucose level monitors. I came across the following and wonder if there are negative or postive implications for CRII:
MiniMed Inc. Announces Unanimous Conditional Recommendation Of FDA Panel For Continuous Glucose Monitoring System To Treat Diabetes
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Sylmar, California, February 26, 1999 - MiniMed Inc. (Nasdaq: MNMD) today announced that a Food and Drug Administration (FDA) Advisory Panel has issued a conditional recommendation for agency approval of MiniMed's premarket approval application (PMA) for a system designed to provide continuous glucose monitoring for people with diabetes. The Panel has unanimously recommended that the FDA approve the PMA, subject to the satisfaction of certain pre-market, post-market and labeling conditions.
MiniMed's PMA relates to a physician monitor product to be used as a tool in treating patients with diabetes, much like a cardiac Holter-style monitor. MiniMed's continuous glucose sensor is designed to be inserted into the subcutaneous tissue, usually in the abdominal area, utilizing a soft cannula type device.
Commenting on the announcement, Alfred E. Mann, MiniMed's Chairman and CEO, stated, "We are pleased with the Panel's unanimous action today and intend to begin addressing the Panel's recommendations and conditions immediately." Terrance H. Gregg, President and Chief Operating Officer, added, "We are appreciative of these recommendations and look forward to providing another tool to advance the state of diabetes care."
MiniMed Inc. designs, develops, manufactures and markets advanced infusion systems with a primary emphasis on the intensive management of diabetes. The Company's products include external pumps and related disposables, as well as the distribution of an implantable insulin pump, which is currently approved for sale in the European Community and has not yet been cleared for marketing in the U.S. The Company also distributes other diabetes supplies and pharmaceutical products. The Company has submitted an application for marketing clearance for a system designed to continuously monitor glucose levels, is preparing to introduce other continuous glucose monitoring system products, and is developing new infusion systems to deliver compounds designed to treat a variety of medical conditions.
Any statements made by MiniMed in this press release that are forward-looking, including statements relating to the ability to complete successfully the clinical research activities relating to MiniMed's continuous glucose monitoring system, the ability to obtain regulatory approval with respect to any continuous glucose monitoring system product and the commercial market for MiniMed's continuous glucose monitoring system products are made pursuant to the Safe Harbor provisions of the Private Securities Reform Act of 1995. Investors are cautioned that forward-looking statements involve risks and uncertainties which may affect MiniMed's business and prospects, including changes in economic and market conditions, acceptance of MiniMed's products by the health care and reimbursement communities, health care legislation, new developments in diabetes therapy, administration and regulatory approval and related considerations, and other factors discussed in the Company's filings with the Securities and Exchange Commission.
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For:
MiniMed Inc. (818) 362-5958
Terrance H. Gregg
President and Chief Operating Officer
Kevin R. Sayer
Senior Vice President and Chief Financial Officer
Morgen-Walke Associates
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