Studies Show SpectRx Continuous Glucose Prototypes Track Blood Measurements Over Extended Time.Business Editors SAN ANTONIO--(BUSINESS WIRE)--June 12, 2000 Company to begin milestone clinical study in July with second-generation units SpectRx, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : SPRX) presented data showing that its laser-based glucose monitoring glucose monitoring Lab medicine The periodic evaluation of any analyte abnormal in Pts with DM, to assess short and long-term control with antiglycemic agents. See Glucose, Glycated hemoglobin. prototypes are capable of continuously measuring glucose in people with diabetes over an extended time with a correlation to fingerstick blood measurements of approximately 90%. The research presented at the American Diabetes Association The American Diabetes Association, or the ADA, is an American health organization providing diabetes research, information and advocacy. Founded in 1940, the American Diabetes Association conducts programs in all 50 states and the District of Columbia, reaching hundreds of annual meeting matched 1,001 data pairs in three separate clinical studies. The company also demonstrated second-generation continuous glucose monitoring meter and sensor prototypes, which will be used in upcoming milestone clinical studies, scheduled to begin in July. Two people with diabetes, participating in developmental clinical studies wore the palm-sized second-generation units. Based on SpectRx's biophotonic technology, the continuous glucose monitoring sensor, worn on top of the skin, offers the promise of allowing people with diabetes to continuously monitor their glucose levels without the pain and inconvenience of fingerstick blood tests or implanting a sensor. Prototypes of the device have shown the capability of providing readings once a minute. The SpectRx technology measures glucose levels in interstitial fluid interstitial fluid n. The fluid in spaces between the tissue cells. Interstitial fluid The fluid between cells in tissues. Referred to as the liquid subtance of the body. Mentioned in: Lymphedema (ISF ISF - Information Systems Factory ) rather than blood. A stream of ISF is collected through an array of micropores created with a laser in the stratum corneum stratum cor·ne·um n. The horny outer layer of the epidermis, consisting of several layers of flat, keratinized, nonnucleated, dead or peeling cells. Also called corneal layer, horny layer. , the dead outer layer of skin, and measured in a patch containing a glucose sensor. It is envisioned that the final design sensor patch would be used for up to three days. Clinical studies, presented at the ADA Ada, city, United States Ada (ā`ə), city (1990 pop. 15,820), seat of Pontotoc co., S central Okla.; inc. 1904. It is a large cattle market and the center of a rich oil and ranch area. meeting, focused on development of second-generation system components as well as evaluating the performance of the integrated system in long term studies. In the product development studies, tests involving 100 subjects were performed to study duration of interstitial fluid (ISF) flow in adults and children with diabetes. Continuous flow could be measured on multiple sites on the body for up to 96 hours. Integrated system studies of tracking between continuous interstitial glucose measurements and fingerstick blood glucose blood glucose Diabetology The principal sugar produced by the body from food–especially carbohydrates, but also from proteins and fats; glucose is the body's major source of energy, is transported to cells via the circulation and used by cells in the presence measurements involved 66 patient tests conducted with 43 people with diabetes. These tests resulted in 1,001 separate paired data points for correlation analysis. Three different studies were conducted, including daylong tracking studies, ISF/blood glucose lag time studies and extended overnight studies. Correlations between the ISF continuous glucose measurements and the fingerstick blood glucose measurements were .901, .894 and .898 respectively. The ISF/blood lag was 11.5 minutes. "Based on our progress to date in developing the continuous glucose monitor, we plan on initiating a 100 patient milestone clinical study next month," said Mark A. Samuels, SpectRx Chairman and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. . "Successful completion of the study will trigger a milestone payment from partner Abbott Laboratories and will move the program into manufacturing and the next stage of product development in anticipation of an FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. filing." Blood glucose levels are a measure of an individual's health status. Because people with diabetes cannot properly metabolize me·tab·o·lize v. 1. To subject to metabolism. 2. To produce by metabolism. 3. To undergo change by metabolism. metabolize to subject to or be transformed by metabolism. glucose, they must frequently monitor their glucose levels by pricking their fingertips to draw the drop of blood necessary for conventional glucose monitoring. The yearly worldwide market for glucose testing is estimated at $3 billion and is growing at an annual rate of 12 to 18 percent. SpectRx, Inc. is a leading biophotonics company that develops and manufactures painless and bloodless alternatives to medical diagnostic and monitoring procedures. For more information, visit the SpectRx web site at www.spectrx.com. Certain matters discussed in this announcement contain forward-looking statements that involve material risks to, and uncertainties in the company's business that may cause actual results to differ materially from those anticipated by the statements made herein. The matters discussed herein should be viewed together with the Risk Factors in the Company's 10K for the year ending December 31, 1999 on file with the SEC. |
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