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Biotech / Medical : Biocontrol Technology - BICO

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To: helkel who wrote (17)7/23/1997 8:34:00 AM
From: Linda Kaplan   of 19
 
Chris Pensinger has been emailing me some info, since he still is on "mute" here. He thought the 1994 press release would be of some interest: December 1994 Diasensor IOOOTM NON-INVASIVE GLUCOSE SENSOR UPDATE FDA Status As most of you are aware, we submitted a 510(k) Notification to the Food and Drug Administration (FDA) on January S, 1994. We felt at that time that our product,since it is a new technology, would take approximately five (S) months for the approval process. The average 510(k) submission under a Class II device used to take approximately 90 days for approval. However, this process has been slowed down due to the number of applications submitted in the past year. On December 1, 1994, we attended a meeting with the FDA staff in their offices in Rockville, Maryland. Representing Biocontrol was Dave Purdy, chairman and president of Biocontrol, two (2) members of his technology team, two (2) physicians who specialize in endocrinology, and Fred E. Cooper, chief executive officer. In the meeting, we addressed various questions on the technology, as well as medical questions asked by their medical representative. The FDA requested some additional data that we are in the process of providing to them through our patients being tested at our testing facility in Indiana, Pennsylvania. In addition, they want testing data from two (2) other locations. We have commenced testing at one of those locations and are in the process of setting up the other site. This recent meeting with the FDA was most important so that. they could see our people face to face and understand that we have top professionals in their fields employed in our company. Both the FDA and we left the meeting with a very positive understanding. Going forward, we are very optimistic of getting an approval once we have completed the additional testing that they have requested. Manufacturing Plant Status All of the lease-hold improvements have been completed in the office area at the manufacturing plant. There are approximately 13 people working there at the present time, and there will be a number of people hired in the next three to five months at the facility. The facility looks good, brand new and very impressive. The actual manufacturing area in the rear of the facility is being completed. There is another 30 to 60 days worth of work that has to be done in this area. We are awaiting various equipment to come in, most of which has already been ordered. We hope to have this facility ready for sub-assembly in the Spring. We won't get the facility up to its maximum capacity until later in the year; however, we still should be able to manufacture 1,500 to 2,000 units per month in the interim. Marketing Update of the Diasensor l0OO TM Diasense, Inc., which is an affiliate company of Biocontrol Technology, has already set up offices outside of the United States and is presently taking orders. Those offices are located in Mexico City, London, and Buenos Aires, Argentina. We are positioning sales in these cities so that we can take orders immediately which will allow us to strategize our gearing up in manufacturing. We want to have international as well as United States representation in Diasense, so that we can take advantage of highly populated markets in all areas. Obviously, everyone cannot afford a machine at an approximate price of $8,000; therefore, we must appeal to the mass markets; namely, the larger cities. We will not set up many more offices outside the country, because once we have FDA approval, the demand in the United States will be quite strong. -end-
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