ALBANY, N.Y., Sept. 29, 2011 (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 Company has completed patient enrollment in its multi-center European prospective NanoKnife® System trial (ONC-205) for the treatment of hepatocellular carcinoma (HCC), the most common form of primary liver cancer.
The purpose of this Company-sponsored trial is to evaluate the safety and efficacy of the NanoKnife System for the treatment of early-stage HCC. Eligibility was based on subjects having one to three tumors of a size no greater than 3 cm. Study subjects are allowed one retreatment with the NanoKnife System.
"We look forward to the scientific findings from this prospective clinical trial," said President and Chief Executive Officer Joseph DeVivo. "The clinical results will be of particular interest as the subjects have not been treated with other modalities, meaning any response obtained is directly attributable to the NanoKnife System."
During the study, there have been no 30-day mortalities and no serious adverse events (SAEs) associated with the NanoKnife System. Doctors reported three SAEs not related to treatment. The primary endpoint is tumor response assessment at 30-days post treatment with imaging, with subjects followed to end-of-life to determine overall survival as a secondary endpoint.
In all, 26 subjects at five European sites have been treated in the study, titled, "A Prospective, Multi-Center, Clinical Trial Using Irreversible Electroporation (IRE) for the Treatment of Early-Stage Hepatocellular Carcinoma (HCC)." It is being conducted by Professor Jordi Bruix of the Barcelona Clinic Liver Cancer (BCLC) Group of the University of Barcelona and Professor Riccardo Lencioni of the University of Pisa School of Medicine. Updates and details on the study can be found at http://1.usa.gov/HCCStudy.
About Hepatocellular Carcinoma
Hepatocellular carcinoma is the most common form of liver cancer and according to a report from the National Cancer Institute, the incidence of this devastating disease is increasing, and has increased more than 200% between 1975 and 2005. Hepatitis B and hepatitis C are primary risk factors for HCC. The same study reported that despite progress in treating HCC the one-year survival rate remains below 50%.
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, vascular access products, angiographic products and accessories, angioplasty products, drainage products, thrombolytic products, embolization products and venous products. More information is available at www.AngioDynamics.com.
'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, 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, 2011. AngioDynamics does not assume any obligation to publicly update or revise any forward-looking statements for any reason.
In the United States, NanoKnife has been cleared by the FDA for use in the surgical ablation of soft tissue. NanoKnife has not been cleared for the treatment or therapy of a specific disease or condition. This document may discuss the use of NanoKnife for specific clinical indications for which it is not cleared in the United States at this time.
CONTACT: Company Contact:
AngioDynamics, Inc.D. Joseph Gersuk, CFO
(800) 772-6446 x1608
Investor Relations Contacts:
EVC Group, Inc.Greg Gin/Doug Sherk
(646) 445-4801; (415) 652-9100
EVC Group, Inc.Chris Gale
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