Healthcare Industry News: access device
News Release - July 30, 2008
Escalon(R) Receives FDA 510(k) Clearance to Market the LIASYS(TM) Clinical Chemistry and Immunoturbidimetric Analyzer
Company's Fourth FDA 510(k) Clearance Since December 2007WAYNE, Pa., July 30 (HSMN NewsFeed) -- Escalon Medical Corp. (Nasdaq: ESMC ) today announced that the United States Food and Drug Administration ("FDA") has cleared the 510(k) submission for the LIASYS(TM) bench top clinical chemistry and immunoturbidimetric analyzer. The Company's recently acquired JAS Diagnostic ("JAS") unit is the distributor for the LIASYS analyzer in the United States and supplier of the associated chemistry reagents. JAS prepared and submitted the 501(k) application on behalf of the manufacturer, Analyzer Medical System, headquartered in Rome, Italy. The analyzer is being introduced at the 2008 Annual Meeting for the American Association for Clinical Chemistry ("AACC") currently being held in Washington D.C.
LIASYS is a fully automatic random access, continuous loading, easy access bench top clinical chemistry and immunoturbidimetric analyzer. The instrument features primary tubes sampling, capacitive liquid level sensing, positive identification of the samples, and module for ion selective electrode ("ISE"). It is suitable to perform the daily routine of low/medium-sized laboratories in an entirely safe and reliable way, providing flexible and cost effective solutions. The LIASYS multitasking and user-friendly software enhances the system's potential and performance.
"We believe this is an attractive chemistry analyzer that offers an excellent combination of sampling speed, precision, reliability, and ease of use," commented David Johnston, President of JAS Diagnostics. "We have optimized and validated a broad range of dedicated reagents for LIASYS and anticipate benefiting directly from an ongoing chemistry reagent revenue stream." JAS, which was acquired by Escalon in May 2008, plans to submit chemistry panels for FDA Clinical Laboratory Improvement Amendment ("CLIA") classification, necessary in order to for moderately-complex laboratories to use the analyzer, and anticipates the classifications to be obtained over the next several months.
Richard J. DePiano Sr., Chairman and Chief Executive Officer added, "We are pleased to announce this FDA clearance, which not only illustrates the strategic value of our recent acquisition of JAS Diagnostic but also our ability to expand our position in the clinical chemistry market. We remain committed to meeting the needs of the clinical community and delivering innovative and cost-effective technologies."
JAS is a manufacturer of class I and II in vitro diagnostics ("IVD") reagents that markets its products to physician, reference, hospital and veterinary laboratories throughout the world.
Founded in 1987, Escalon (www.escalonmed.com) 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 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, Miami, Florida, 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. These statements 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 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 for year ended June 30, 2007 and on Form 10Q for the quarter ended March 31, 2008, and its other filings with the Securities and Exchange Commission, all of which are available from the Securities and Exchange Commission as well as other sources.
Source: Escalon Medical
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