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Health Canada Approves ANGO's Celerity System

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AngioDynamics (ANGO - Free Report) revealed that its global distribution partner Medcomp Inc. has received approval by Health Canada for commercial sale of its Celerity tip location system. The Celerity tip location system is based on an ECG-based peripherally inserted central catheter (PICC) tip confirmation technology. It is used as an alternative to chest x-ray and fluoroscopy for PICC tip placement in patients.

In January this year, AngioDynamics entered a global distribution agreement with Medcomp for the Celerity tip location system. With the recent approval by Health Canada, ANGO would gain a competitive advantage over its rivals in the Canadian health care market. The Celerity system when combined with thrombus-resistant BioFlo technology provides unique clinical and economic advantages to the company.

AngioDynamics will start distributing the Celerity system in Canada from next month. The company plans to showcase the system at the Association for Vascular Access (AVA) Annual Scientific Meeting that would take place from Sep 20 to Sep 23 in Nashville, Tenn.

Last month, ANGO announced that its subsidiary Navilyst Medical Inc. has received 510(k) clearance from U.S. Food and Drug Administration (FDA) for its BioFlo Port that is built with Endexo technology to bring down accumulation of catheter-related thrombus.

BioFlo Port is a permanent and non-eluting integral polymer. It is also available with PASV Valve Technology, a patented valve produced by AngioDynamics, which automatically resist backflow and reduce blood reflux on the inside of the catheter. The port is expected to launch in the third quarter of ANGO’s fiscal 2014.

ANGO reported more than twofold year-over-year increase in adjusted earnings to 7 cents per share for the fourth quarter of fiscal 2013 ended May 31, surpassing the Zacks Consensus Estimate by 2 cents. For fiscal 2013, adjusted earnings surged 66.7% to 35 cents per share and beat the Zacks Consensus Estimate by a penny.

Revenues declined 2% to $90.0 million on a pro forma basis, exceeding the Zacks Consensus Estimate of $89 million. Pro forma results include the Navilyst acquisition and exclude the LC Beads sales. Lower revenues were attributable to difficult year-over-year comparisons.

AngioDynamics expects fiscal 2014 revenues in the range of $346–$352 million, up 3% at the top range from the previous guidance. Adjusted earnings per share are expected in the range of 31 cents to 35 cents for the fiscal, taking into account the impact from the medical device tax.

For the first quarter of fiscal 2014, management expects to generate revenues in the range of $81 million–$84 million, flat year over year at the top end. Adjusted earnings per share are anticipated between 2 cents−4 cents. Excluding amortization, adjusted earnings per share are expected between 10 cents and 12 cents.

ANGO is a leading provider of medical devices for vascular access, surgery, peripheral vascular disease and oncology. Currently, it retains a Zacks Rank #3 (Hold).

While we prefer to remain on the sidelines about AngioDyanmics, other medical instrument companies such as Cynosure, Inc. , Echo Therapeutics, Inc. and Luminex Corporation (LMNX - Free Report) warrant a look. All these stocks carry a Zacks Rank #2 (Buy).

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