ALBANY, N.Y., Oct. 28, 2014 (GLOBE NEWSWIRE) -- AngioDynamics (Nasdaq:ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, surgery, peripheral vascular disease and oncology, today announced the Germany Ministry of Health has issued an OPS (a procedure classification code) for the company's NanoKnife System. This process is the first step in securing reimbursement for new medical technologies in Germany.
Currently, there are seven NanoKnife systems in Germany, used primarily in patients who suffer from liver, prostate, kidney and lung cancers. Use of the system is usually paid for by the patient or the costs are picked up through a research grant at a university hospital. Being granted an OPS is an important step in the universal acceptance of a medical technology.
"The issuance of the OPS by the German Ministry of Health is an enormous advancement in the successful implementation of the NanoKnife technology in the German market," said Rick Stark, Senior Vice President of AngioDynamics' Global Oncology/Surgery Franchise. "With OPS in-hand, the Ministry can now document the technology's benefits and determine an appropriate level of reimbursement according to German Diagnosis Related Groups (G-DRGs) for a variety of specific procedures."
Eleven new OPS Codes have been introduced, including: bile ducts, 5-513.44; bone, 5-789.9; liver, 5-501.7; lung, 5-339.22; stomach, 5-433.7; adrenal gland, 5-073.42; kidney, 5-552.9; esophagus, 5-422.7; prostate 5-601.8; pancreas, 5-521.3; and rectum 5-482.e.
"The inclusion of the IRE-Procedures for different types of tissue into the German OPS-Catalogue highlights the relevance of this novel treatment method," added Dr. Philipp Wiggerman, of University Hospital in Regensburg, Germany.
The pathway to a reimbursement code for a medical device in Germany can take a year or more as it requires multiple agency filings and support from each scientific society that treats specific disease states. The G-DRG for NanoKnife is expected by January 1, 2015, with reimbursement occurring as early as April 2015 as facilities go through their individual applications for reimbursement.
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, 2014. 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.
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