Escalon Extends Product Portoflio with Third FDA Market Clearance Since
December 2007
WAYNE, Pa., Jan. 29 /PRNewswire-FirstCall/ -- 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."
About VascuView(TM)
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 Corp.
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CONTACT: Richard J. DePiano, Chairman and CEO of Escalon Medical Corp., +1-610-688-6830; or Joseph Calabrese of Financial Relations Board for Escalon Medical Corp., +1-212-827-3772
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