ALBANY, N.Y., Aug. 21, 2013 (GLOBE NEWSWIRE) -- AngioDynamics (Nasdaq:ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, surgery, peripheral vascular disease and oncology, announced the enrollment of the first patient at Academic Medical Center, Amsterdam, The Netherlands, by the Clinical Research Office of the Endourological Society (CROES) in an investigator-led, multi-center study assessing the safety, efficacy and patient satisfaction of the NanoKnife System for the ablation of prostate cancer. This study is the first of two studies that will comprise the CROES project. A second, randomized study among 200 patients will
begin after the conclusion of the safety study.
The study titled, "The Safety and Efficacy of Irreversible Electroporation (IRE) for the Ablation of Prostate Cancer Assessed by Procedural Related Side Effects and Post Prostatectomy Histology: A Prospective Human In-Vivo Study," will enroll 16 patients who have been diagnosed with histopathologically confirmed, organ confined prostate cancer and are scheduled for a prostatectomy. Eligible patients will be asked to undergo treatment with NanoKnife System approximately 30 days prior to the prostatectomy.
"Over the past decade, there has been an increased interest in examining effective focal therapies for the treatment of low-risk prostate cancers," said Jean de la Rosette, Professor and Chairman of the Department of Urology, at AMC University Hospital in Amsterdam and lead investigator. "As more widespread screenings have led to an increased diagnosis of prostate cancers, it is important to explore treatments that are more proactive than surveillance but less radical than near-whole prostate gland ablation. I look forward to examining the NanoKnife system's potential."
Primary endpoints will be safety as measured by the number of adverse events. Efficacy endpoints will be measured by the complete ablation of the specified targeted ablation zone as measured pre- and post-prostatectomy. Additional data will be collected towards the assessment of secondary endpoints including patient satisfaction, and whether procedural side effects associated with current treatments for prostate cancer — mainly incontinence, erectile dysfunction and bowel damage — are avoided. The study will take place at three sites including, Academic Medical Center, Amsterdam, The Netherlands; Institut Mutualiste Montsouris, Paris, France; and the Athens Medical School, Athens,
"The enrolling of patients in this study parallels work being done in the U.S., where institutions like the University of Miami have agreed to participate in a study upon IRB approval," said Rick Stark, Senior Vice President of AngioDynamics' Oncology/Surgery Business. "The urology field wants to examine focal ablation as an option that takes advantage of the latest imaging technology to provide less invasive solutions for patients, and we are committed to supporting research that enables better prostate cancer treatments."
The Endourological Society is one of the major Societies with a strong global presence in the fields of endourology and emerging technologies. The Society supports especially the global diffusion of knowledge and skills in these fields. To further advance the field of endourology and emerging technologies, the implementation of high level basic and clinical scientific research within the Endourological Society is of great importance.
The Clinical Research Office of the Endourological Society (CROES) is an official organ within the Endourological Society responsible for organizing, structuring and favoring a global network on endourological research. The CROES was founded during the World Congress on Endourology meeting 2008 in Shanghai and has been operational for more than four years now. The CROES council is composed of a Chairperson and 6 international members (2 American, 2 European, 2 Asian). The operational activities will be located in the office of the chairperson of CROES, whereas headquarters of CROES is located in New York (Endourological Society office).
AngioDynamics Inc. is a leading provider of innovative, minimally invasive medical devices used by professional healthcare providers for vascular access, surgery, peripheral vascular disease and oncology. AngioDynamics' diverse product lines include market-leading ablation systems, fluid management systems, vascular access products, angiographic products and accessories, angioplasty products, drainage products, thrombolytic products and venous products. More information is available at www.AngioDynamics.com.
AngioDynamics, the AngioDynamics logo and NanoKnife are trademarks and/or registered trademarks of AngioDynamics Inc., an affiliate or a subsidiary.
This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements regarding AngioDynamics' expected future financial position, results of operations, cash flows, business strategy, budgets, projected costs, capital expenditures, products, competitive positions, growth opportunities, plans and objectives of management for future operations, as well as statements that include the words such as "expects," "reaffirms," "intends," "anticipates," "plans," "believes," "seeks," "estimates," "optimistic," or variations of such words and similar expressions, are forward-looking statements. These forward looking statements are not guarantees of future performance and are subject to risks and uncertainties. Investors are cautioned that actual events or results may differ
from AngioDynamics' expectations. Factors that may affect the actual results achieved by AngioDynamics include, without limitation, the ability of AngioDynamics to develop its existing and new products, technological advances and patents attained by competitors, future actions by the FDA or other regulatory agencies, domestic and foreign health care reforms and government regulations, results of pending or future clinical trials, overall economic conditions, the results of on-going litigation, the effects of economic, credit and capital market conditions, general market conditions, market acceptance, foreign currency exchange rate fluctuations, the effects on pricing from group purchasing organizations and
competition, the ability of AngioDynamics to integrate purchased businesses, including Navilyst Medical and its products, R&D capabilities, infrastructure and employees as well as the risk factors listed from time to time in AngioDynamics'SEC filings, including but not limited to its Annual Report on Form 10-K for the year ended May 31, 2013. AngioDynamics does not assume any obligation to publicly update or revise any forward-looking statements for any reason.
In the United States, the NanoKnife System has been cleared by the FDA for use in the surgical ablation of soft tissue, and is similarly approved for commercialization in Canada, the European Union and Australia. The NanoKnife System carries the CE mark for cell membrane electroporation. The NanoKnife System has not been cleared for the treatment or therapy of a specific disease or condition.
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