ALBANY, N.Y., March 6, 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 U.S. Food and Drug Administration (FDA) rejected its distribution partner, Medcomp Inc.'s, 510(k) application for the Celerity tip location system.
AngioDynamics has determined the Agency's decision resulted from the execution of a human factors study rather than the device itself. Following discussions with the Agency, AngioDynamics believes it can fully address these issues in a subsequent filing, which it expects to be submitted in early April.
As a result of these developments, AngioDynamics executed an agreement with Medcomp and Medcomp's development partner to acquire regulatory control over the Celerity platform and exclusive rights to a next generation system that includes navigation capabilities.
"Based on our review and discussions with the Agency, we have established a clear regulatory path to bring Celerity to the U.S. market by mid-summer," said Joseph M. DeVivo, AngioDynamics' President and Chief Executive Officer. "With this new agreement, we have established a clear plan to build a strong tip-location portfolio that includes next-generation product introductions.
"Our Vascular Access Business has been strengthening over the last several quarters with building clinical evidence of our BioFlo thrombus-resistant catheters," DeVivo added. "With our fiscal third quarter closed last week, I am pleased to announce our U.S. Vascular Access Business has returned to growth for the first time since the acquisition of Navilyst, joining our already growing International Vascular Access Business. I am looking forward to the commercial introduction of Celerity in the U.S., which will only accelerate the positive momentum our business has."
AngioDynamics continues to sell Celerity in Canada, where the market response to the combined offering of the system with the Company's thromboresistant BioFlo PICC has been positive.
"We remain committed to emulating our success in Canada, leveraging the Celerity tip location system to bolster our growing BioFlo PICC business in the U.S.," said Chuck Greiner, Senior Vice President of AngioDynamics' Global Vascular Access Business. "With the amount of positive user data on BioFlo products growing, we are beginning to see an acceleration of hospital conversions and a renewed strength in our Vascular Access Business. A key poster on BioFlo PICCs was presented in the quarter at the 2014 ANA Quality Conference, where the data from BioFlo once again confirmed significant clinical and economic results compared to the competition. In total, there are now more than 2,000 data points reporting similar findings. We are confident our new regulatory and development strategy for tip location will enable us to quickly bring Celerity to the U.S. market, as well as provide us with a competitive next-generation system that includes integrated EKG and navigation capabilities."
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 BioFlo are trademarks and/or registered trademarks of AngioDynamics Inc., an affiliate or a subsidiary. Celerity is a trademark and/or registered trademark of Medcomp Inc.
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, 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.