MiniMed Inc. Submits FDA Notification On Continuous Glucose Sensor For DiabetesSylmar, Calif.--December 17, 1997--MiniMed Inc. (Nasdaq: MNMD) today announced that it has submitted an application for 510(k) clearance from the United States Food and Drug Administration to produce and market its continuous subcutaneous glucose sensor. MiniMed expects to utilize the sensor for a series of products, the first two of which will be a physician diagnostic device and an alarm product to warn people with diabetes of dangerously low glucose levels. The submission includes results from MiniMed's multi-center clinical trial which recently has been completed. MiniMed's technology is contrasted with the intermittent measurements currently available through traditional glucose meters and test strips, which require pricking a finger with a needle to extract a drop of blood several times a day, and is widely thought to deter compliance due to the pain and inconvenience associated with the process.
The current worldwide market for glucose meters and strips is estimated at almost $3 billion annually.
MiniMed's sensor is designed to be inserted into the subcutaneous tissue, usually in the abdominal area, utilizing a soft cannula type device. The physician diagnostic device is to be worn by a patient for three days to gather and store continuous glucose readings that can then be downloaded to a personal computer for analysis. The hypoglycemia alert alarms when the patient's glucose level drops below the limit established by the administering physician. These devices measure glucose levels every 10 seconds and record averages over five minute intervals. After obtaining additional clinical experience with its initial products, MiniMed anticipates filing for FDA clearance for a third system for consumer monitoring which would be designed to replace traditional glucose meters and strips.
Alfred E. Mann, Chairman and Chief Executive Officer, stated, "We are extremely excited about our subcutaneous glucose sensor products, which we believe will be the industry's first ambulatory continuous sensor systems for monitoring glucose levels for people with diabetes. It is well recognized that aggressive management of glucose levels by diabetics is necessary to avoid the long-term complications of the disease, including blindness, kidney failure, amputations, cardiovascular disease and impotence. In intensive management, patients today take multiple measurements, some as many as sixteen times per day. The pain and inconvenience associated with existing therapy deters compliance. Not only did the clinical trial results underscore the accuracy and stability of our sensor, but also demonstrated that the current practice of a few intermittent measurements of glucose daily is inadequate. Even patients believed to be well controlled experience several extraordinarily wide daily swings of glucose often with lows of 30 to 50 mg/dl to highs of 250 to 350 mg/dl." Mr. Mann added, "The information that these products will provide for diabetic patients and their physicians will offer significant advantages by enabling them to monitor their glucose levels much more effectively and without the compliance and technical limitations of traditional meters and strips. The results of our clinical trials suggest that our sensors may significantly improve the way diabetes is managed."
Terrance H. Gregg, President and Chief Operating Officer, added, "We believe that our subcutaneous glucose sensor products, once approved, can not only bring significant revenues, but will also fuel sales of our insulin infusion pumps. The wide variations in glucose levels which were evident during our trials are best managed through microdose infusion that is available through infusion pumps." Mr. Gregg added, "We hope for approval of our first products in 1998. We are establishing a pilot production plant in our existing facilities and we are in final negotiations for a definitive site on which to build a facility to enable achieving high volume manufacturing."
MiniMed Inc. designs, develops, manufactures and markets advanced infusion systems for the treatment of a variety of medical conditions, with a focus on the intensive management of diabetes and other medical conditions. The Company's products include external pumps and related disposables, as well as an implantable insulin pump, which is currently approved for distribution in the European Community and has not yet received permission to be marketed in the U.S. The Company is also developing glucose monitoring systems designed to continuously monitor glucose levels and 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 regulatory approval for its glucose sensor products, the ability of MiniMed to file for regulatory approval with respect to additional sensor products, the ability of MiniMed to manufacture its sensor products, the commercial market for MiniMed's glucose sensor products and the impact of commercial introduction of such products on MiniMed's insulin infusion pump business 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.
News Release on MiniMed Web Site
Posted 28 Dec 97
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