VANCOUVER, May 1 /PRNewswire-FirstCall/ - Angiotech Pharmaceuticals, Inc. (NASDAQ: ANPI, TSX: ANP), a global specialty pharmaceutical and medical device company, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to begin marketing sizes 3-0 and 4-0 of its Quill Self-Retaining System (SRS) Polydioxanone (PDO) product line. The Quill SRS PDO is a longer-lasting absorbable suture, which is typically used for deeper tissue closures. These smaller diameter sizes incorporate a new design for better holding strength and expand the number and scope of procedures that can be done with the Quill SRS product.
“We are pleased to receive 510(k) approval for these new smaller diameter sizes. We intend to continue to broaden our Quill SRS product offering to cover multiple procedures for wound closure and tissue approximation,” said Dr. William Hunter, President and CEO of Angiotech.
Angiotech plans to exhibit the Quill SRS product line at the Annual Meeting of the American Society for Aesthetic Plastic Surgery (ASAPS) to be held May 1-6 in San Diego, California.
About the Quill(TM) Self-Retaining System (SRS)
The Quill SRS represents a revolutionary technology in wound closure made possible by bidirectional fixation within the wound. Its patented design allows the surgeon to begin closure at the midpoint of the wound and suture in two directions from the midpoint. Barbs within the Quill SRS distribute tension across the wound and eliminate the need for knots. This highly efficient, knot-less system can save significant procedural time in the operating room while also enhancing wound closure.
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 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 drug discovery and clinical development processes; 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 or consummate acquisitions; the accuracy of our estimations of the size of the market, and the potential market, for our products in specific disease areas; sales numbers and future guidance publicly provided by Boston Scientific Corporation regarding sales of their paclitaxel-eluting coronary stent products; 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: 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 ability of Boston Scientific Corporation to successfully manufacture, market and sell their paclitaxel-eluting coronary stent products; the continued availability of capital to finance our activities; our ability to achieve the financial benefits expected as a result of the acquisition of American Medical Instruments Holdings, Inc.; 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. 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.
Quill(TM) is a trademark of Quill Medical, Inc., a wholly-owned subsidiary of Angiotech Pharmaceuticals, Inc. ©2008 Angiotech Pharmaceuticals, Inc. All Rights Reserved.
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: ANPI, TSX: ANP), please visit our website at www.angiotech.com.
CONTACT: Deirdre Neary, Manager, Investor Relations and Corporate Communications, Angiotech Pharmaceuticals, Inc., (604) 222-7056, dneary@angio.com
Source: Angiotech Pharmaceuticals, Inc.
