BioSpace.com

Biotech and Pharmaceutical
News & Jobs
Search the Site
 
   
Biotechnology and Pharmaceutical Channel Medical Device and Diagnostics Channel Clinical Research Channel BioSpace Collaborative    Job Seekers:  Register | Login          Employers:  Register | Login  

NEWSLETTERS
Free Newsletters
Archive
My Subscriptions

NEWS
News by Subject
News by Disease
News by Date
PLoS
Search News
Post Your News
JoVE

CAREER NETWORK
Job Seeker Login
Most Recent Jobs
Browse Biotech Jobs
Search Jobs
Post Resume
Career Fairs
Career Resources
For Employers

HOTBEDS
Regional News
US & Canada
  Biotech Bay
  Biotech Beach
  Genetown
  Pharm Country
  BioCapital
  BioMidwest
  Bio NC
  BioForest
  Southern Pharm
  BioCanada East
  US Device
Europe
Asia

DIVERSITY

INVESTOR
Market Summary
News
IPOs

PROFILES
Company Profiles

START UPS
Companies
Events

INTELLIGENCE
Research Store

INDUSTRY EVENTS
Biotech Events
Post an Event
RESOURCES
Real Estate
Business Opportunities

 News | News By Subject | News by Disease News By Date | Search News
eNewsletter Signup
Miles
Km80.5

   

AngioDynamics (ANGO) Receives FDA Warning Letter Regarding Certain NanoKnife(R) System Promotional Activities


1/26/2011 6:30:37 AM

ALBANY, N.Y.--(BUSINESS WIRE)-- AngioDynamics (NASDAQ:ANGO - News) today announced the receipt of a warning letter from the U.S. Food and Drug Administration (FDA) regarding certain aspects of the Company’s marketing program for its NanoKnife® System. The NanoKnife System continues to be commercially available in the United States under its 510(k) clearance for the surgical ablation of soft tissue and in certain international markets under CE Mark or other relevant approvals. The FDA letter states that certain statements made by AngioDynamics, including those on its Web site, promote the use of the NanoKnife System beyond its currently cleared indications. AngioDynamics is taking actions to address the matters raised by the FDA and will work closely with the agency to resolve any outstanding issues.

“Our goal is to always comply with all regulations regarding our products,” said Jan Keltjens, AngioDynamics President and CEO. “We have already begun to respond to the matters raised by the FDA and are committed to addressing them promptly. We remain committed to our strategy of working with the FDA toward expanded labeling for the NanoKnife System.”

About AngioDynamics

AngioDynamics, Inc. is a leading provider of innovative medical devices used by interventional radiologists, surgeons and other physicians for the minimally-invasive treatment of cancer and peripheral vascular disease. AngioDynamics’ diverse product lines include market-leading ablation systems, vascular access products, angiographic products and accessories, dialysis products, angioplasty products, drainage products, thrombolytic products, embolization products and venous products. More information is available at www.angiodynamics.com.

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,” 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, future actions by the FDA or other regulatory agencies, results of pending or future clinical trials, overall economic conditions, the results of on-going litigation, 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, 2010. AngioDynamics does not assume any obligation to publicly update or revise any forward-looking statements for any reason.

Until the matters raised in the aforementioned warning letter are corrected, we may be subject to additional regulatory action by the FDA, and any such actions could significantly disrupt our business and operations and have a material adverse impact on our financial position and results of operations. There can be no assurance that the FDA will be satisfied with our response. The warning letter will be posted on the FDA’s Web site at www.fda.gov and, once posted, will be available for viewing.

Contact:

AngioDynamics, Inc. D. Joseph Gersuk, CFO, 800-772-6446 ext. 1608 jgersuk@AngioDynamics.com or EVC Group, Inc. Doug Sherk, 415-896-6820 (Investor Relations) dsherk@evcgroup.com Gregory Gin, 415-896-6820 (Investor Relations) ggin@evcgroup.com Chris Gale, 646-201-5431 (Media) cgale@evcgroup.com

Read at BioSpace.com

   

ADD TO DEL.ICIO.US    ADD TO DIGG    ADD TO FURL    ADD TO STUMBLEUPON    ADD TO TECHNORATI FAVORITES