AngioDynamics, Inc. (ANGO) Tuesday said it has initiated a voluntary recall of a software feature for clinical determination of the ablation zone, on NanoKnife Systems installed in the U.S. The temporary hold on sale of the systems is expected to impact revenues for the second half of its fiscal year, leading to a scale back in guidance for the remaining two quarters of its fiscal year.
Resumption of shipments of the company's NeverTouch Procedure Kits are expected to partially offset the NanoKnife impact. The company has halted U.S. NanoKnife System shipments and currently expects to resume U.S. shipments without the software during the fiscal fourth quarter ending May 31.
The company expects the development to reduce NanoKnife System sales in the second half of fiscal year 2012 by about $3.6 million. In the second quarter ended November 30, 2011, NanoKnife System contributed $3.2 million in worldwide sales, approximately half of which were outside the U.S.
AngioDynamics has initiated a voluntary recall in the U.S. of the NanoKnife System's Ablation Zone Estimator or AZE software, including the User's Manual and Troubleshooting Guide. The recall does not impact NanoKnife Systems or sales outside of the U.S.
The FDA recently indicated that the AZE feature should be the subject of a 510(k) pre-market notification submission and clearance. The company has decided to remove the feature pending modification and notified customers that the feature should not be used in the U.S. for treatment planning of the therapy area.
The NanoKnife System has FDA 510(k) clearance for the surgical ablation of soft tissue. AngioDynamics added the AZE feature to the NanoKnife System pursuant to a Letter to File, a process by which companies make modifications to products that are already cleared.
For the third quarter, the company now expects earnings of $0.05 - $0.07 per share, adjusted earnings of $0.07 - $0.09 per share, on revenues of $50.9 - $52.9 million. The prior guidance for the third quarter was earnings of $0.07 - $0.09 per share, adjusted earnings of $0.09 - $0.11 per share, with revenues of $52.0 - $54.0 million. The Street currently expect earnings of $0.10 per share for the February quarter on revenues of $52.8 million.
Fourth-quarter earnings are seen at $0.10 - $0.12 per share, on revenues of $52.1 - $54.1 million. The prior outlook for the May quarter had been earnings of $0.11 - $0.13 per share on revenues of $53.5 - $55.5 million.
Full-year earnings are now expected at $0.29 - 0.34 per share on revenues of $215.5 - $219.5 million. Adjusted earnings for the full year are expected at $0.38 - $0.42 per share.
The prior guidance had been for earnings of $0.32 to $0.37 per share, adjusted earnings of $0.41 to $0.45 per share, and sales of $218 million to $222 million.
The Street currently expect full-year earnings of $0.43 per share on revenues of $220.5 million.
The Latham, New York-headquartered company reported positive customer response after the resumption of shipments of its NeverTouch Procedure Kits for use with the VenaCure EVLT Laser Vein Ablation System, following a voluntary recall earlier this month due to supplier component nonconformances.
ANGO closed Tuesday's regular trading at $13.59, up $0.32 or 2.41%, on the Nasdaq. Over the past year, the stock traded in a range of $12.60 - $17.19.
For comments and feedback contact: editorial@rttnews.com
Business News
June 12, 2026 17:14 ET Major central bank action was the focus this week in economic news. The European Central Bank became the first major central bank to move in response to the rising inflationary pressures in the backdrop of the conflict in the Middle East. In North America, the U.S. inflation and trade data as well as Canada’s central bank decision gained attention. The Chinese trade data was the main news in Asia.