BIOCONTROL TECHNOLOGY, INC.
2275 Swallow Hill Road - Building 2500 - Pittsburgh, PA 15220
(412) 429-0673 Fax: (412) 279-1367
BIOCONTROL UPDATES PROGRESS OF DIASENSOR 1000 (TM) SENSOR
Pittsburgh, PA - March 22, 1996 - Biocontrol Technology, Inc. (NASDAQ:BICO) announced today that the Food and Drug Administration (FDA) recently responded to the February 26, 1996 panel review of the Company's Diasensor 1000 (TM) noninvasive glucose sensor by requesting BICO to submit a study design for collecting additional data on the Diasensor 1000 production model. The Company is communicating with the FDA on the matter.
Biocontrol also announced that four production models are now complete. The three most recently produced units are undergoing laboratory tests while successful calibration has been achieved on the first unit produced which has generated encouraging data during testing of several patients.
David L. Purdy, president of Biocontrol, said "Thus far, the data collected on this production model has been much better than that which was generated from the research model. As previously reported by Biocontrol, in bench tests the production model has shown significant improvement in data collection efficiency which may allow the sensor to obtain a reading more than 50% of the time and at a faster rate. With the research model, because of interferences caused by skin variability," continued Purdy, "the noninvasive sensor produced a glucose reading 50% of the time requested. However, the reading obtained was just as accurate as invasive meters used in the home by diabetics. Actually, because there is very little chance for user error, a glucose reading obtained on the Diasensor 1000 can be even more accurate than one obtained with invasive meters which have a long list of possible user errors."
Assembly of 30 additional production models will commence the first week of April at Biocontrol's Manufacturing Center in Indiana, PA. By early May, the Company anticipates having all 30 units completed, 20 of which will be field tested on patients. The remaining ten units will be studied by Biocontrol scientists for possible areas of improvement.
Once the field tests on the 20 units have been successfully completed, Biocontrol will begin shipment to the London office for sales there while the Company continues its approval process with the FDA.
Biocontrol Technology, Inc. has its corporate offices in Pittsburgh, PA and is involved in the development and manufacture of biomedical devices and environmental products.
Last Updated: Thursday August 29, 2002 20:59:48
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