ANGO Gets FDA Approval for BioFlo Port

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AngioDynamics (ANGO) revealed that its subsidiary Navilyst Medical Inc. 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.

The port is a small medical appliance installed beneath the skin and connected by a catheter to a vein. Through the port, drugs are injected for a long time and patient's vascular system can be accessed for repeated intravenous treatments such as chemotherapy, blood withdrawal or delivery of total parenteral nutrition.

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.

The breakthrough BioFlo technology reduces the accumulation of catheter-related thrombus without incorporation of heparin, antibiotics or antimicrobials, or any other transient materials associated with coated or impregnated technologies. It is the second FDA clearance received by a product built with this advanced technology.

In August last year, AngioDynamics received FDA approval for its BioFlo peripherally inserted central catheters (PICCs) built with Endexo technology. This product already received CE mark for Europe and approvals in Canada and other international markets.

As per in-vitro blood loop model test results, BioFlo Port catheter has 96% less thrombus accumulation on its surface compared to non-coated conventional port catheters while BioFlo PICC has 87% less thrombus accumulation on its surface on average compared to other PICCs based on platelet count.

The ports used for thrombosis costs nearly $1 billion per year to the U.S. healthcare system. Over 50,000 deaths occur due to thromboembolism annually and most of the cancer patients are susceptible to this disorder.

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 Cyberonics Inc. (CYBX), Echo Therapeutics, Inc. (ECTE) and Luminex Corporation (LMNX) warrant a look. All these stocks carry a Zacks Rank #2 (Buy).

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