Hemo-Stream(TM) Chronic Dialysis Catheter Receives FDA Clearance
29 August 2007 - 2:00PM
PR Newswire (US)
VANCOUVER, Aug. 29 /PRNewswire-FirstCall/ -- Angiotech
Pharmaceuticals, Inc. (NASDAQ:ANPINASDAQ:TSX:NASDAQ:ANP), a global
specialty pharmaceutical and medical device company, today
announced that the U.S. Food and Drug Administration (FDA) has
given clearance to begin marketing the Hemo-Stream(TM) chronic
dialysis catheter. The Hemo-Stream catheter, developed by Rex
Medical, LP, is the first chronic hemodialysis catheter
specifically designed for over-the-wire delivery. Its advantages
include higher flow rates due to its triple lumen design, reduced
potential for air embolism or bleeding, decreased procedural steps
and time versus competition, and ease of catheter placement.
Dialysis catheters, such as Hemo-Stream, are used for short term
vascular access to provide hemodialysis patients with the dialysis
they require. In April 2007, Angiotech entered into an agreement
with Rex Medical whereby Rex Medical granted Angiotech an exclusive
license to market and distribute the Hemo-Stream catheter
worldwide. "The Hemo-Stream catheter is a great complement to the
vascular graft business we acquired from Edwards and our Vascular
Wrap AV access trials which are currently enrolling," said Dr.
William Hunter, President and CEO of Angiotech. "With over 500,000
End Stage Renal Disease patients in the U.S., Angiotech is focused
on the development and commercialization of innovative dialysis
care products that improve the treatment options available to
hemodialysis patients and vascular surgeons." It is expected that
Hemo-Stream catheters will be available for commercial sale in the
U.S. later this year. About Rex Medical, LP Rex Medical, LP, based
in Conshohocken, PA, is a privately held medical device company
specializing in the development, manufacturing and marketing of
minimally invasive medical devices targeted towards the
cardiovascular, venous access, endosurgery and oncology markets.
Note on Forward Looking Statements Statements contained in this
press release that are not based on historical fact, including
without limitation statements containing the words "believes,"
"may," "plans," "will," "estimate," "continue," "anticipates,"
"intends," "expects" and similar expressions, constitute
"forward-looking statements" within the meaning of the U.S. Private
Securities Litigation Reform Act of 1995 and constitute
"forward-looking information" within the meaning of applicable
Canadian securities laws. All such statements are made pursuant to
the "safe harbor" provisions of applicable securities legislation.
Forward-looking statements in this release include but are not
limited to statements regarding; financial benefits to Angiotech
that could potentially be realized from Angiotech's sale of the
Hemo-Stream product, the ability of Angiotech to commercialize the
Hemo-Stream product and to develop and commercialize any successive
product lines, that a substantial market exists for the product,
and that the product will perform as expected. Such forward-looking
statements involve known and unknown risks, uncertainties and other
factors that may cause the actual results, events or developments
to be materially different from any future results, events or
developments expressed or implied by such forward-looking
statements. Many such risks, uncertainties and other factors are
taken into account as part of our assumptions underlying these
forward-looking statements and include, among others, the
following; general economic and business conditions, both
nationally and in the regions in which we operate; market demand;
technological changes that could impact our existing products or
our ability to develop and commercialize future products;
competition; existing governmental regulations and changes in, or
the failure to comply with, governmental regulations; decisions,
and the timing of decisions, made by health regulatory agencies
regarding approval of our technology and products; the requirement
for substantial funding to conduct research and development and to
expand commercialization activities; and any other factors that may
affect performance. In addition, our business is subject to certain
operating risks that may cause the actual results expressed or
implied by the forward-looking statements in this report to differ
materially from our actual results. These operating risks include;
poor performance of the product in the clinical setting; adverse
events related to the use of the product; improper estimation of
the size of the market for the product; adverse results or
unexpected delays in clinical development processes; our ability to
attract and retain qualified personnel; our ability to successfully
complete preclinical and clinical development of our products;
changes in business strategy or development plans; our failure to
obtain patent protection for discoveries; loss of patent protection
resulting from third party challenges to our patents;
commercialization limitations imposed by patents owned or
controlled by third parties; our ability to obtain rights to
technology from licensors; liability for patent claims and other
claims asserted against us; our ability to obtain and enforce
timely patent and other intellectual property protection for our
technology and products; the ability to enter into, and to
maintain, corporate alliances relating to the development and
commercialization of our technology and products; market acceptance
of our technology and products; our ability to successfully
manufacture, market and sell our products; the continued
availability of capital to finance our activities; and any other
factors referenced in our annual information form and other filings
with the applicable Canadian securities regulatory authorities or
the SEC. Given these uncertainties, assumptions and risk factors,
readers are cautioned not to place undue reliance on such
forward-looking statements. We disclaim any obligation to update
any such factors or to publicly announce the result of any
revisions to any of the forward-looking statements contained in
this prospectus to reflect future results, events or developments.
Hemo-Stream(TM) is a trademark of Rex Medical, LP used under
license by Angiotech. About Angiotech Angiotech Pharmaceuticals,
Inc. is a global specialty pharmaceutical and medical device
company with over 1,500 dedicated employees. Angiotech discovers,
develops and markets innovative treatment solutions for diseases or
complications associated with medical device implants, surgical
interventions and acute injury. To find out more about Angiotech
(NASDAQ:ANPINASDAQ:TSX:NASDAQ:ANP), please visit our website at
http://www.angiotech.com/. CONTACT: Deirdre Neary, Manager,
Investor Relations and Corporate Communications, Angiotech
Pharmaceuticals, Inc., (604) 222-7056, DATASOURCE: Angiotech
Pharmaceuticals, Inc. CONTACT: Deirdre Neary, Manager, Investor
Relations and Corporate Communications, Angiotech Pharmaceuticals,
Inc., (604) 222-7056,
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