Clinical Study Results for TCPI's Noninvasive TD Glucose Monitoring System to be Presented At the 17th International Diabetes Federation Congress.Business/Health Editors POMPANO BEACH, Fla.--(BUSINESS WIRE)--Sept. 11, 2000 TCPI TCPI To Complete Performance Index TCPI Toiletries and Cosmetics Purchasing Index , Inc. (Nasdaq:TCPI), a manufacturer and worldwide marketer of point-of-care medical diagnostic products, today announced that researchers involved in a clinical study of the Company's noninvasive TD Glucose(TM) Monitoring System will present clinical data at the 17th International Diabetes Federation The International Diabetes Federation (IDF) is a worldwide alliance of 200 diabetes associations in more than 150 countries, who have come together to enhance the lives of people with diabetes everywhere. For over 50 years, IDF has been at the vanguard of global diabetes advocacy. Congress being held in Mexico City on November 5-10, 2000. Janet B. McGill, M.D., Associate Professor of Medicine and Director of the Diabetes Research and Training Center at the Washington University School of Medicine Washington University School of Medicine, located in St. Louis, Missouri, is one of the most competitive and highly regarded medical schools and biomedical research institutes in the United States. will present results from a clinical study "Transdermal 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. System: Comparison Between Patient Specific And Universal Calibration During Extremes Of Hypo And Hyperglycemia hyperglycemia: see diabetes. " conducted at the university's diabetes research center in St. Louis, Missouri. TCPI's Vice President of Transdermal Research, Frank M. Kochinke, Ph.D., is the co-author of this presentation. Dr. Kochinke has more than 20 years of pharmaceutical industry and academic experience in the mechanisms of skin (transdermal) transport systems. He has in excess of 25 scientific publications to his credit and holds 10 U.S. patents related to transdermal drug delivery systems and manufacturing with five additional patent applications pending. Dr. Kochinke holds a Ph.D. in chemical engineering from the Technische Universitat in Berlin. For this study, diabetic patients were hospitalized and medical professionals controlled patients' glucose levels to extreme hypoglycemic hypoglycemic /hy·po·gly·ce·mic/ (-gli-sem´ik) 1. pertaining to, characterized by, or causing hypoglycemia. 2. an agent that lowers blood glucose levels. (low) and hyperglycemic hyperglycemic /hy·per·gly·ce·mic/ (-gli-se´mik) 1. pertaining to, characterized by, or causing hyperglycemia. 2. an agent that increases the glucose level of the blood. (high) states. Blood glucose levels were taken at regular intervals and measured using the One Touch(R)Profile(TM) meter for capillary finger-stick 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 and the industry's highest standard laboratory equipment - a Yellow Springs Instrument (YSI YSI Yousendit (File Transfer Website) YSI Youth Science Institute YSI You Stupid Idiot ) - for venous blood venous blood n. Abbr. v Blood that has passed through the capillaries of various tissues other than the lungs, is found in the veins, in the right chambers of the heart, and in pulmonary arteries, and is usually dark red as a result of a glucose. Parallel glucose measurements were obtained using TCPI's noninvasive TD Glucose Monitoring System. The results of the Washington University School of Medicine study demonstrated a high degree of correlation between the TD Glucose Monitoring System and the finger-stick blood glucose method at hypo- and hyperglycemic extremes. Clarke-Error-Grid analysis showed tight clustering in the desired A region for most patients. The correlation value was r2 = 0.93 using individual calibration and r2 = 0.88 using a universal set of parameters. The study concluded that pain free glucose monitoring using the TD Glucose Monitoring System is possible with accuracy comparable to capillary blood glucose measurements. Individual calibration increases the accuracy of the system. A Newsweek cover story in the September 4, 2000 issue and a recent New York New York, state, United States New York, Middle Atlantic state of the United States. It is bordered by Vermont, Massachusetts, Connecticut, and the Atlantic Ocean (E), New Jersey and Pennsylvania (S), Lakes Erie and Ontario and the Canadian province of Times article published on August 24, 2000, reported a substantial increase in the incidence of diabetes in the United States from 1990 to 1998, including a 76% rise in cases among people in their 30's. The study was conducted by the diabetes division of the Center for Disease Control and Prevention Noun 1. Center for Disease Control and Prevention - a federal agency in the Department of Health and Human Services; located in Atlanta; investigates and diagnoses and tries to control or prevent diseases (especially new and unusual diseases) CDC and researchers went on to warn that diabetes will take a harsh toll in disability, death and medical expenses in the decades to come. Doctors attribute much of the increase to obesity, which has also been steadily rising, allowing the researchers to predict that Type 2 (adult onset) diabetes will continue to accelerate. The rate of Type 1 (juvenile) has remained about the same. Worldwide there are in excess of 130 million people diagnosed with diabetes - 16 million are in the U.S. - and millions more have diabetes, but are not yet diagnosed. According to National Institutes of Health and other studies, glucose monitoring is recommended 4 to 6 times a day to enable diabetics to better keep their blood glucose levels in a narrow range and guard against debilitating de·bil·i·tat·ing adj. Causing a loss of strength or energy. Debilitating Weakening, or reducing the strength of. Mentioned in: Stress Reduction medical complications. Of those with diabetes, only 18 to 20 million people regularly monitor their glucose levels. Diabetes is among the top 10 leading causes of death in the U.S. and can also lead to other life threatening conditions, including blindness, kidney and neurological disease, limb amputation amputation (ăm'pyətā`shən), removal of all or part of a limb or other body part. Although amputation has been practiced for centuries, the development of sophisticated techniques for treatment and prevention of infection has greatly , heart disease and stroke. Medical costs in the U.S. for the treatment of diabetes and related long-term conditions are approximately $100 billion annually. About the TD Glucose(TM) Monitoring System The Company's TD Glucose(TM) Monitoring System is completely noninvasive, nontoxic and safe. A small skin patch skin patch, transdermal patch, or transdermal delivery system, adhesive patch used to deliver a controlled dose of a drug through the skin over a period of time. provides diabetics with a painless, bloodless, easy to use and rapid method to monitor their glucose levels. After the patch has been placed on the forearm for five minutes, a small electronic meter is held up to the patch and produces an instant glucose reading. The single-use patch is then removed and discarded. The TD Glucose Monitoring System combines proprietary and patent-pending transdermal technology with TCPI's patented membrane technology used in most of its other diagnostic products on the market and in various stages of development. The alliance of these technologies permits dermal dermal /der·mal/ (der´mal) pertaining to the dermis or to the skin. der·mal or der·mic adj. Of or relating to the skin or dermis. glucose to be drawn and transported into the patch where it causes a chemical reaction and color change in the membrane. Special optics in an electronic meter detects the color change and provides a glucose reading. The TD Glucose Monitoring System is presently involved in the clinical trial process. Upon completion, the Company anticipates making a submission to the U.S. Food & Drug Administration seeking marketing clearance. The retail price of the TD Glucose Monitoring System is expected to be competitive with currently available finger-stick blood glucose monitoring blood glucose monitoring Sugar monitoring Lab medicine The periodic testing of serum glucose in Pts known to have DM. See Bedside glucose monitoring, Beta cell implants, Diabetes, Glucometer, Glycosylated hemoglobin, Non-Invasive glucose monitoring. systems. About TCPI TCPI, Inc. manufactures point-of-care medical diagnostic products for use at home, in physician offices, and other healthcare locations and markets them worldwide through multiple distribution channels under its own HealthCheck(R) brand as well as OEM (Original Equipment Manufacturer) The rebranding of equipment and selling it. The term initially referred to the company that made the products (the "original" manufacturer), but eventually became widely used to refer to the organization that buys the products and (original equipment manufacture) and private label programs. TCPI's key diagnostic products on the market and in development include its HealthCheck(R) brand of at home testing and screening products, noninvasive TD Glucose(TM) Monitoring System for diabetics to monitor glucose levels, HealthCheck Total and HDL Cholesterol HDL cholesterol n. See high-density lipoprotein. HDL Cholesterol About one-third or one-fourth of all cholesterol is high-density lipoprotein cholesterol. Home Screening Tests, professional use TriMeter trim·e·ter n. 1. A line of verse consisting of three metrical feet. 2. A line of verse consisting of three measures of two feet each, especially one in iambic, trochaic, or anapestic meter in classical prosody. (TM) system for analytical monitoring of Total and HDL Cholesterol and blood glucose from a finger-stick, drug of abuse screening tests available in TCPI's branded ScanGuard(TM) and private label One-Step slide, strip or multi-test cassette formats, and over-the counter and professional pregnancy and fertility family planning family planning Use of measures designed to regulate the number and spacing of children within a family, largely to curb population growth and ensure each family’s access to limited resources. products in multiple formats - including TCPI's accurate and easy to use One Step-One Minute Pregnancy Test pregnancy test Any test used to detect or confirm pregnancy; in early pregnancy, all PTs measure hCG, the developing placenta's principal hormone, which is detectable as early as 6 days after fertilization; in clinical laboratories, serum levels of hCG are (TM). Many of TCPI's diagnostic products incorporate its patented and proprietary membrane technology platform. The Company also owns a patent-protected, proprietary portfolio of transdermal and dermal drug delivery technologies and skin permeation enhancers. TCPI presently holds 26 U.S. and foreign patents, and has 61 domestic and foreign patent applications pending. Copies of this and other news releases may be obtained free of charge by calling TCPI's automated fax service at (800) 464-9217. Additional information on the Company can be obtained from TCPI's Web site at www.techchem.com. Information in this press release, including any information incorporated by reference herein, includes "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Act of 1934, as amended, and is subject to the safe-harbor created by such sections. The Company's actual results may differ significantly from the results discussed in such forward-looking statements. Statements regarding development and 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. clearance of future products, future prospects, business plans and strategies, future revenues and revenue sources, the resolution of pending litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called litigation. , future liquidity and capital resources, health care market directions, future acceptance of the Company's products, possible recommendations of health care professionals or governmental agencies regarding use of diagnostic products, possible growth in markets for at-home diagnostic testing Diagnostic testing Testing performed to determine if someone is affected with a particular disease. Mentioned in: Von Willebrand Disease , the possibility and timing of additional equity investments, mergers, acquisitions or other strategic transactions, as well as other statements contained in this report that address activities, events or developments that the Company expects, believes or anticipates will or may occur in the future, and similar statements are forward-looking statements. These statements are based upon assumptions and analyses made by the Company in light of current conditions, future developments and other factors the Company believes are appropriate in the circumstances, or information obtained from third parties and are subject to a number of assumptions, risks and uncertainties. Readers are cautioned that forward-looking statements are not guarantees of future performance and that actual results might differ materially from those suggested or projected in the forward-looking statements. Factors that may cause actual future events to differ significantly from those predicted or assumed include, but are not limited to: the continued listing of the Company's common stock on the Nasdaq National Market, Nasdaq Small Cap Market or Nasdaq Bulletin Board or other stock exchanges; the satisfactory completion of clinical trials demonstrating efficacy of the TD Glucose(TM) Monitoring System; FDA and foreign regulatory clearance of the TD Glucose Monitoring System; delays in product development; risks associated with the Company's ability to successfully develop and market new products on a profitable basis or at all; availability of labor and sufficient parts and materials to complete the design, construction and manufacturing scale-up of required equipment; ability to complete the design, construction and manufacturing scale-up on a timely basis within budget parameters; receipt of any required regulatory approvals for manufacturing equipment or related facilities; future advances in technologies and medicine; the uncertainties of health care reform; risks related to the early stage of the Company's existence and its products' development; the Company's ability to execute its business plans; engineering development; lead time for delivery of equipment; the Company's dependence on outside parties such as its key customers, suppliers, licensing and alliance partners; competition from major pharmaceutical, medical and diagnostic companies; risks and expense of government regulation and effects of changes in regulation (including risks associated with obtaining requisite FDA and other governmental approvals for the Company's products); the limited experience of the Company in manufacturing and marketing products; uncertainties connected with product liability exposure and insurance; risks associated with domestic and international growth and expansion; risks associated with international operations (including risk associated with international economies, currencies and business conditions); risks associated with obtaining and maintaining patents and other protections of intellectual property; risks associated with uncertainty of litigation and appeals, and the payment of judgments not reversed on appeal or otherwise; the Company's limited cash reserves Cash reserves See: Cash investments cash reserves Investment funds that are held in short-term assets such as Treasury bills and certificates of deposit until more permanent investment opportunities are available. and sources of liquidity; uncertainties regarding timing and effectiveness of registration statements; uncertainties in availability of expansion capital in the future and other risks associated with capital markets, including funding of ongoing operations, risks associated with the Company's ability to negotiate and obtain additional financing, equity investments or strategic transactions on favorable terms or at all, as well as those listed in the Company's other press releases and in its other filings with the Securities and Exchange Commission. The Company may determine to discontinue or delay the development of any or all of its products under development at any time. Moreover, the Company may not be able to successfully develop and market new products, complete planned acquisitions, enter into strategic alliances or implement any or all of its operating strategy unless it is able to generate additional liquidity and working capital. For a complete description of the Company's business, products and liquidity, see the Company's Annual Report on Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. for the year ended December 31, 1999 and its Quarterly Reports on Form 10-Q Form 10-Q See 10-Q. for the periods ended March 31, 2000 and June 30, 2000. |
|
||||||||||||||

Printer friendly
Cite/link
Email
Feedback
Reader Opinion