ALBANY, N.Y., Oct. 15, 2015 (GLOBE NEWSWIRE) -- AngioDynamics (NASDAQ:ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, surgery, peripheral vascular disease and oncology, announced today that the NanoKnife® System has been approved by South Korea’s Ministry of Food and Drug Safety (MFDS) for the ablation of soft tissue. The NanoKnife System is the first ablation system to use a series of high-voltage, but low-energy electrical pulses which are believed to permanently open pores in cell membranes.
“As we discussed in our recent earnings call, we have been aggressively registering NanoKnife in countries around the world since receiving our Certificates to Foreign Governments three months ago, and this approval in South Korea is just the latest in a series of approvals,” said Joseph M. DeVivo, President and CEO of AngioDynamics. “The global demand for this product grows as new clinical evidence shows the benefits that NanoKnife can offer to patients, providers and payers. It is a novel technology that has the potential to disrupt the healthcare system’s expectations for care.”
AngioDynamics has already begun selling the NanoKnife system to healthcare providers in South Korea through exclusive distribution partnerships.
“The approval of NanoKnife in South Korea offers further evidence of the incredible value that this system can offer patients worldwide,” said Rick Stark, Senior Vice President of AngioDynamics' Global Oncology/Surgery Franchise. “We have already seen a positive response from customers. The opportunities for us in Asia are tremendous, and the approval of NanoKnife in South Korea continues to expand our market potential.”
In the past 60-days, NanoKnife has been approved by four countries, including Malaysia, South Korea Thailand and Vietnam. NanoKnife Generators are also approved in China. NanoKnife is now approved in 45 countries worldwide. In the United States, the NanoKnife System has received a 510(k) clearance by the Food and Drug Administration for use in the surgical ablation of soft tissue, and is similarly approved for commercialization in Canada, the European Union and Australia. In the United States, the NanoKnife System has not received clearance for the therapy or treatment of any specific disease or condition.
About AngioDynamics
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.
Trademarks
AngioDynamics, the AngioDynamics logo, and NanoKnife, are trademarks and/or registered trademarks of AngioDynamics Inc., an affiliate or a subsidiary.
Safe Harbor
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, 2015. 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 received a 510(k) clearance by the Food and Drug Administration 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.