Healthcare Industry News: vascular access
News Release - January 29, 2008
Escalon(R) Announces FDA 510(K) Clearance for VascuView(TM) Visual Ultrasound System For Assisted Vascular AccessEscalon Extends Product Portoflio with Third FDA Market Clearance Since December 2007
WAYNE, Pa., Jan. 29 (HSMN NewsFeed) -- Escalon Medical Corp. (Nasdaq: ESMC ) today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the VascuView(TM) Visual Ultrasound System for use with assisted vascular access. Its subsidiary, Escalon vascular access, Inc., plans to commence shipments of the product in the United States immediately.
"We are excited to announce the FDA clearance and introduction of the new VascuView(TM) Visual Ultrasound System," said Michael O'Donnell, President of Escalon vascular access. "Developed with doctors and clinicians ultrasound needs in mind, the VascuView(TM) system couples unparalleled portability with a large image display and intuitive touchscreen operation which allow users to focus on the task at hand. Whether mounted on a stand, used table top bedside, or fit into a carrying case for field use, the VascuView(TM) is highly adaptable to the challenges of varying departmental environments within a hospital."
Richard J. DePiano Jr., President of Escalon Medical Corp. commented, "The clearance of the VascuView(TM) system is a very promising milestone as it not only reflects the successful culmination of our research and development efforts but represents our third FDA market clearance in the last six weeks. We remain committed to meeting the needs of the clinical community by delivering innovative and cost-effective technologies."
The VascuView(TM) Visual Ultrasound System utilizes a tablet pc with software built on the Microsoft Windows XP platform. The probe itself contains the ultrasound circuitry and connects via a USB-2 interface. Features of the system include:
-- Large image display providing easy visualization of targeted vessels and surrounding anatomy
-- Touchscreen display with intuitive and straightforward user interface
-- Scan operation controls on the probe itself allowing maintenance of sterile field
-- Visualization of depth to 6cm with excellent resolution and accuracy
-- Software tools including calipers for measuring vessel size and needle guide overlay to provide direction to intended vessel
Mr. O'Donnell added, "The timing of the VascuView(TM) introduction is key, as clinicians continue to adopt the use of ultrasound as a standard of care and technique for vascular access to ensure efficacy and reduce complications. The addition of the VascuView(TM) Visual Ultrasound System to our existing PD Access(TM) and SmartNeedle(TM) Doppler Ultrasound Guided Needles, allows Escalon vascular access to offer a complete product line for assisted vascular access needs."
Escalon vascular access specializes in the design, manufacture and distribution of instruments for assisted vascular access, including the PD Access(TM) and SmartNeedle(TM) Doppler-guided vascular access assemblies, which are used to locate desired vessels for access. These patented devices utilize a miniature Doppler ultrasound probe that is positioned within the lumen of a needle. When a Doppler-guided needle is inserted subcutaneously, the probe and monitor can differentiate when an artery or vein is approaching and guide successful access. The devices are distributed worldwide and used across several specialty groups including cardiac catheterization labs, intensive and critical care units, and interventional radiology.
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
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