Healthcare Industry News: metabolic disease
News Release - July 17, 2007
Escalon(R) Receives 510(k) Clearance from FDA for Distribution of TRILOGY(R) AnalyzerChemistry Analyzer Complements Augments Escalon's Suite of Hematology Products
WAYNE, Pa., July 17 (HSMN NewsFeed) -- Escalon Medical Corp. (Nasdaq: ESMC ) announced today that its Drew Scientific business unit received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the new TRILOGY Analyzer. TRILOGY, a multifunction analyzer used in determination of analytes in body fluids, is an open system intended for clinical use in a professional setting for use with various chemistry assays. The analyzer is currently on display at the 2007 AACC Annual Meeting and Clinical Lab Expo held in San Diego, CA. Drew Scientific plans to commence shipments of the product in the United States immediately.
"We are excited about broadening our product portfolio and having FDA clearance of the new multi-purpose analyzer in time for the opening of the AACC conference this week," commented Richard J. DePiano, Chairman and Chief Executive Officer. "The TRILOGY system augments our existing hematology base business providing Drew Scientific with the ability to offer turnkey solutions in both chemistry and hematology."
TRILOGY was designed for the quantitative determination of glucose, creatinine and urea nitrogen in serum. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia and idiopathic hypoglycemia, and of pancreatic islet call carcinoma. Creatinine measurements are used in the diagnosis and treatment of renal diseases and in monitoring renal dialysis. Urea nitrogen measurements are used in the diagnosis and treatment of certain renal and metabolic diseases. TRILOGY includes an optional Ion Selective Electrodes (ISE) module for the measurement of sodium, and chloride in serum and urine. These measurements are used to monitor electrolyte balance and in the diagnosis and treatment of diseases involving electrolyte imbalance.
Drew Scientific is a diagnostics company specializing in the design, manufacture and distribution of instruments for blood cell counting and blood analysis. Drew Scientific is focused on providing instrumentation and consumables for the physician office and veterinary office laboratories. Drew Scientific also supplies the reagent and other consumable materials needed to operate the instruments.
Founded in 1987, Escalon develops markets and distributes ophthalmic diagnostic, surgical and pharmaceutical products as well as vascular access devices. Drew Scientific, which operates as a separate business unit, provides instrumentation and consumables for the diagnosis and monitoring of medical disorders in the areas of diabetes, cardiovascular diseases and hematology, as well as veterinary hematology and blood chemistry. Escalon seeks to utilize strategic partnerships to help finance its development programs and is also seeking acquisitions to further diversify its product line to achieve critical mass in sales and take better advantage of Escalon's distribution capabilities, although any such partnerships or acquisitions may not occur. Escalon has headquarters in Wayne, Pennsylvania and manufacturing operations in Long Island, New York, New Berlin, Wisconsin, Dallas, Texas, Oxford, Connecticut and Barrow-in-Furness, U.K.
Note: This press release contains statements that are considered forward- looking under the Private Securities Litigation Reform Act of 1995, including statements about Escalon's future prospects. They are based on Escalon's current expectations and are subject to a number of uncertainties and risks, and actual results may differ materially. The uncertainties and risks include whether Escalon is able to:
-- implement its growth and marketing strategies, improve upon the operations of Escalon's business units, including the integration of Drew Scientific's and MRP's operations, the reorganization of the Drew Scientific's business and the integration of any acquisitions it may undertake, if any, of which there can be no assurance;
-- implement cost reductions;
-- generate cash; and
-- identify, finance and enter into business relationships and acquisitions.
Other factors include uncertainties and risks related to:
-- new product development, commercialization, manufacturing, product liability and market acceptance of new products,
-- marketing acceptance of existing products in new markets, the continuity of royalty revenue, litigation and non-recurring expenses;
-- research and development activities, including failure to demonstrate clinical efficacy;
-- delays by regulatory authorities, scientific and technical advances by Escalon or third parties;
-- introduction of competitive products;
-- third party reimbursement and physician training, and
-- general economic conditions.
Further information about these and other relevant risks and uncertainties may be found in the Company's report on Form 10-K, and its other filings with the Securities and Exchange Commission, all of which are available from the Commission as well as other sources.
Source: Escalon Medical
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