Healthcare Industry News: hematology analyzer
News Release - December 18, 2007
Escalon(R) Announces FDA 510(K) Clearance for D3 Hematology SystemWAYNE, Pa., Dec. 18 (HSMN NewsFeed) -- Escalon Medical Corp. (Nasdaq Capital Market: ESMC) today announced that its Drew Scientific subsidiary received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the D3 Hematology System, an automatic three-part differential hematology analyzer. Drew Scientific plans to commence shipments of the product in the United States by month-end.
"The FDA clearance represents a major step for Drew, as it now provides two upgraded instruments for sale in fiscal 2008 along with the TRILOGY Analyzer that was approved in July," said Frank Matuszak, Drew's Vice President of Sales and Marketing. "For the past twelve months, we have successfully distributed the D3 System outside of the United States. We expect that the D3 will be equally well received in the U.S. marketplace."
The D3 Hematology System adds to the Company's wide range of top quality and leading edge hematology systems. This flexible and easy-to-use instrument offers simple installation, low maintenance and immediate user acceptance and productivity. The D3 incorporates advanced technology for superior reliability of 3-part differential blood analysis. Features include:
-- Low reagent consumption and very small sample size to minimize laboratory waste.
-- Advanced user flexibility with easy-to-use built-in color touch screen, providing on screen histograms and storage of up to 500 records and QC statistics.
-- Easy installation and user interface with multi-language capability.
For additional information on the D3 Hematology System, please visit the Drew Scientific web site at www.drew-scientific.com.
Doug Nickols, President of Drew Scientific, commented, "FDA clearance is another important step in the continued development of the D3 Hematology System. With this advancement and continued growing interest in the D3 System abroad, we expect to accelerate the pace of our analyzer placements worldwide."
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, Waterbury, 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 the Company's future prospects. They are based on the Company'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 the Company is able to
-- implement its growth and marketing strategies, improve upon the operations of the Company's business units, including the integration of Drew's and MRP's operations, the reorganization of the Drew business and the integration of any acquisitions it may undertake, if any, of which there can be no assurance,
-- implement cost reductions,
-- generate cash,
-- identify, finance and enter into business relationships and acquisitions. Other factors include uncertainties and risks related to
-- new product development, commercialization, manufacturing and market acceptance of new products,
-- marketing acceptance of existing products in new markets,
-- 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
Issuer of this News Release is solely responsible for its
Please address inquiries directly to the issuing company.