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Tuesday, Oct 3, 2023


MiniMed Inc. is awaiting Food and Drug Administration approval for a revolutionary glucose sensor that will give diabetics the most precise way yet of monitoring their blood sugar levels. An FDA advisory panel recommended approval of the Continuous Glucose Monitoring System in February. The final green light could come any time in the next few weeks, according to Alfred Mann, founder and CEO of the Sylmar-based medical technology manufacturer. “Our ultimate objective is to create an artificial pancreas,” Mann said. The glucose monitor is a big step in that direction. It is the first home testing device designed to allow diabetics to continuously track blood sugar and thus make more precise determinations about when they need insulin and how much to take. As part of the system, a tiny electrode is fitted beneath the skin of the abdomen and connected to a monitor (about the size of a pager) attached to a belt or waistband. With the MiniMed sensor, blood sugar is measured every 10 seconds. The information can be stored for up to three days and then downloaded at a doctor’s office for interpretation. Initial models would be made available only to doctors and dispensed to the public through prescriptions. Eventually, the monitors are expected to be available at drug stores for about $12 each. Later models also would include a low-blood-sugar alarm to alert people about drastic fluctuations. “We are planning two different systems.” Mann said. “The first system consists of external sensor and external pump. Our medical research group is developing the next generation, which is an implantable system.” Since MiniMed received preliminary approval from the FDA on Feb. 26, its stock has been climbing. On the day of the announcement, it closed at $85.25. On April 16, it reached $113.80 and the company distributed a 2-for-1 stock split. As of May 26, it was at $59.125. Phillip Nalbone, an analyst with Volpe Brown Whelan & Co. in San Francisco, said the sensor could bring MiniMed upwards of $50 million in sales over the next few years. Net income for the first quarter ended April 2 was $3.7 million, compared with $2.3 million for the like period last year. “They have a very sensible approach to creating this market,” Nalbone said. “The stock has done well because the company has consistently done what it said it was going to do and met or exceeded Street expectations.” MiniMed is only one part of Mann’s involvement with the biotechnology community. Last year, he donated $100 million to USC and intends to donate another $100 million to UCLA. In addition, he is funding a 28-acre, $80 million research park at Cal State Northridge. Among the more successful MiniMed products is a disposable insulin pump that diabetics can wear to provide a continual flow of insulin. About 60,000 are in use in the United States. The glucose sensor would complement the pump by “micro-managing” the insulin dosage and determining how much is administered. MiniMed’s ultimate goal is to create an artificial pancreas for diabetics that will regulate fluctuating blood sugar as food is digested. (A sudden surge of blood sugar in a diabetic can lead to coma or even death.) Work on the glucose sensor began in 1986 and involved upwards of 60 scientists at any given time. Originally, about $30 million was spent on research and development at the Alfred E. Mann Foundation. These studies were transferred to MiniMed in 1993 as part of the effort to create the sensor now being considered by the FDA. After an additional $15 million in spending, the device was presented to the agency.

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