×

FDA Lifts Warning Letters on AngioDynamics’ Facilities

ALBANY, N.Y., Dec. 03, 2015 (GLOBE NEWSWIRE) -- AngioDynamics (NASDAQ:ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, surgery, peripheral vascular disease and oncology, received letters from the United Stated Food and Drug Administration (FDA) closing out warning letters received by the Company in May 2011 related to the company’s Queensbury facility and November 2014 related to the Glens Falls and Marlborough facilities. These latest actions, in addition to the November 17 announcement that the FDA had lifted a warning letter from January 2011, resolve all FDA warning letters against AngioDynamics.

“The removal of the final warning letters is a reflection of the exceptional quality and operations teams we have today at AngioDynamics. Over the past four years, they have worked diligently with the FDA to fully address the issues and help to instill a culture within the company that is committed to quality and compliance,” said Joseph M. DeVivo, President and CEO of AngioDynamics. “The resolution of these issues is a significant boost to AngioDynamics and improves our ability to drive the growth of the business, especially in international markets.”

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 and the AngioDynamics logo 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 and its quarterly report on form 10-Q for the fiscal quarter ended August 31, 2015. AngioDynamics does not assume any obligation to publicly update or revise any forward-looking statements for any reason.

Company Contact: AngioDynamics Inc. Caitlin Stefanik (518) 795-1418 cstefanik@angiodynamics.com Investor Relations Contacts: EVC Group, Inc. Doug Sherk/Chris Dailey (646) 445-4801 dsherk@evcgroup.com/ cdailey@evcgroup.com Media Contact: EVC Group, Inc. Dave Schemelia (646) 201-5431 dave@evcgroup.com

Source:AngioDynamics