Longport Gains Additional FDA Marketing Clearance
December 08 2006 - 7:00AM
Business Wire
Longport, Inc. (OTC PK: LPTI), a medical technology specialist in
high-frequency, high-resolution ultrasound imaging, today announced
that it had gained additional FDA marketing clearance for its
EPISCAN high-resolution ultrasound imaging system. The expanded
clearance, which has the FDA reference number K062571, is
summarized by the indications of use statement below and is in
addition to the FDA clearance previously obtained under reference
number K990238. This clearance will enable Longport to directly
market for specific clinical applications as described below. �The
EPISCAN I-200 high-resolution ultrasound system is a specialized
system for imaging the skin and underlying soft tissue. It is
intended for use by clinicians, or under the direction of
physicians for imaging and analysis in research environments as
well as clinical settings including medical / surgical dermatology
assessment and diagnosis (aesthetic and therapeutic), plastic /
reconstructive surgical planning, wound assessment and management,
skin assessment for pressure ulcer detection and prevention and
superficial musculoskeletal diagnosis.� Paul Wilson, President of
Longport commented. �During 2006, Longport�s strategy included
obtaining regulatory acceptance, embarking on an expanded clinical
study program and the publication of study results, as well as
continued research and development to enhance our technological
base. This deliberate process for gaining recognition for the use
of our technology as well as validating the benefits is necessary
to establish commercial markets for our products and gain
acceptance for the use of diagnostic ultrasound in markets where
imaging technology is not firmly established.� About Longport, Inc.
Longport, Inc. of Glen Mills, Pennsylvania, is a medical technology
company that specializes in high-resolution ultrasound imaging.
After several years and a multimillion dollar investment in the
technology, Longport has secured patents, copyrights and FDA
permission to market. The Company�s technology has been used to
engineer a unique high-resolution ultrasound imaging system. For
further information please contact Longport, Inc. at 1-800-289-6863
or visit our website at www.longportinc.com. Forward-looking
Information and the Private Securities Litigation Reform Act of
1995 Certain statements in this press release, including statements
concerning product development milestones and anticipated events,
are �forward-looking statements� within the Private Litigation
Reform Act of 1995. Forward Looking Statements are based on the
opinions and estimates of management at the time the statements are
made and are subject to certain risks and uncertainties that could
cause actual results to differ materially from those anticipated in
the forward-looking statements. The words �believe,� �expect,�
�intend,� �anticipate,� variations of such words, and similar
expressions identify forward-looking statements, but their absence
does not mean that the statement is not forward-looking. These
statements are not guarantees of future performance and are subject
to certain risks, uncertainties and assumptions that are difficult
to predict. Factors that could affect Longport�s actual results
include, among others, uncertainties as to the Company�s ability to
manage potential problems, delays or anticipated expenses,
including problems, delays or expenses involving manufacturing.
Readers are cautioned not to place undue reliance upon these
forward-looking statements that speak only to the date of this
release. Reference is made to Longport�s 2004 annual report on Form
10-K filed with the Securities and Exchange Commission for a more
definitive description of such factors. Longport, Inc. undertakes
no obligation to update publicly any forward-looking statements to
reflect new information, events or circumstances after the date of
this release or to reflect the occurrence of unanticipated events.
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