Healthcare Industry News: dialysis
News Release - August 12, 2008
Angiotech receives CE Mark approval of HemoStream(TM) Chronic Dialysis CatheterVANCOUVER, Aug. 12 (HSMN NewsFeed) - Angiotech Pharmaceuticals, Inc. (NASDAQ: ANPI, TSX: ANP), a global specialty pharmaceutical and medical device company, today announced that it has received CE Mark approval to begin marketing the HemoStream(TM) Chronic dialysis Catheter in Europe.
This CE Mark approval follows Angiotech's announcement in August 2007 that it had received clearance from the U.S. Food and Drug Association (FDA) to begin marketing HemoStream in the United States. In April of the same year, Angiotech entered into an agreement with Rex Medical, LP that granted Angiotech an exclusive license to market and distribute HemoStream worldwide.
"This CE Mark approval is another example of the international acceptance of Angiotech's technologies. With Rex Medical as our worldwide licensing partner, we look forward to expanding HemoStream's availability in Europe as well as in the United States," said Dr. William Hunter, President and CEO of Angiotech.
About the HemoStream Chronic dialysis Catheter
Incidences of End Stage Renal Disease (ESRD) requiring dialysis are a rapidly growing challenge in healthcare worldwide. When kidneys fail, function of the kidneys can be partially replaced using a process called hemodialysis. This process involves drawing blood out of the body, filtering it through a large machine and then returning filtered blood back to the body. Chronic dialysis catheters, such as HemoStream, are used as long-term vascular access for hemodialysis. HemoStream may also be used as a temporary access while more permanent options mature or become ready for use, such as surgically created AV fistulas.
About Rex Medical, LP
Rex Medical, LP, based in Conshohocken, PA, is a privately held medical device company specializing in developing, manufacturing and marketing of minimally invasive medical devices targeted towards the cardiovascular, venous access, endosurgery and oncology markets.
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: ANPI, TSX: ANP), please visit www.angiotech.com.
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 may involve, but are not limited to, comments with respect to our objectives and priorities for the second half of 2008 and beyond, and our strategies or future actions, our targets, expectations for our financial condition and the results of, or outlook for, our operations, research development and product and drug development. 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; adverse results or unexpected delays in pre-clinical and clinical product development processes; adverse findings related to the safety and/or efficacy of our products or products sold by our partners; 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, to expand manufacturing and commercialization activities or consummate acquisitions; 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 press release to differ materially from our actual results. These operating risks include: 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; our ability to continue to service our debt obligations; and any other factors referenced in our annual information form and other filings with the applicable Canadian securities regulatory authorities or the Securities and Exchange Commission. Given these uncertainties, assumptions and risk factors, readers are cautioned not to place undue reliance on such forward looking statements. Except as required by law, 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 press release to reflect future results, events or developments.
HemoStream(TM) is a trademark of Rex Medical, LP, used under license by Angiotech Pharmaceuticals, Inc.
Source: Angiotech Pharmaceuticals
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