FDA Grants Prostate IDE Approval for AngioDynamics' NanoKnife System
Pending U.S. Study Parallels European Prostate Efforts
ALBANY, N.Y., June 18, 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 U.S. Food & Drug Administration (FDA) has granted Investigational Device Exemption (IDE) approval to conduct a clinical study of the NanoKnife System for the ablation of focal prostate cancer.
The Company is moving forward with institutional review board (IRB) submissions and anticipates commencing patient enrollment in the Company's fiscal 2014 second quarter, which ends November 30, 2013.
"The time is right to expand the NanoKnife System's evidence base in prostate," said Rick Stark, Senior Vice President of AngioDynamics' Oncology/Surgery Business. "Patients want less invasive procedures, and as imaging technology improves, the urology field is echoing the call by demanding options for focal ablation. With institutions like the University of Miami agreeing to participate in a study upon IRB approval, we are positioned to achieve high-quality insight into the potential for this technology."
Separately, AngioDynamics has established a partnership with the Clinical Research Office of the Endourological Society (CROES) and is pursuing a study to establish evidence for the NanoKnife System's position within the treatment armamentarium for low-intermediate localized prostate cancer. The study, "Multicenter Randomized Two-Arm Intervention Study Evaluating Irreversible Electroporation for the Ablation of Localized Unilateral Prostate Cancer," will involve six European centers and 200 patients.
"AngioDynamics has made a long term investment in the opportunity the NanoKnife System offers to physicians and their patients," said Joseph M. DeVivo, AngioDynamics President and Chief Executive Officer. "The place for this therapy is opening up as we pursue high quality evidence, and we look forward to sharing further details during our fourth quarter fiscal year 2013 earnings report and conference call."
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, 2012. 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 has not been cleared for the treatment or therapy of a specific disease or condition.
CONTACT: Company Contact:
Mark Frost, CFO
(800) 772-6446 x1981
Investor Relations Contacts:
EVC Group, Inc.
Michael Polyviou/Robert Jones
(212)850-6020; (646) 201-5447
EVC Group, Inc.
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