AngioDynamics Gets 3rd FDA Approval for BioFlo - Analyst Blog

AngioDynamics Inc. ANGO revealed that it has received 510(k) clearance for its BioFlo DuraMax chronic hemodialysis catheter from the U.S. Food and Drug Administration (FDA), making it the third approval from FDA for its BioFlo product lienup in ANGO's Vascular Access business.

The BioFlo DuraMax is helpful in treating thrombotic occlusions, which are prevalent in up to 40% of dialysis patients. This advanced dialysis catheter is equipped with Endexo technology.

The catheter's material is more resistant to the accumulations of blood components compared to non-coated conventional catheters. In vitro blood loop model test results revealed that this catheter had 90% less thrombus accumulation on its surface on average compared to non-coated conventional catheters.

The commercial launch of the catheter, which is expected in the fourth quarter of fiscal year 2014, is likely to boost ANGO's 15% share in the $100 million chronic dialysis catheter market in the U.S.

In August last year, ANGO 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.

Thereafter, in Sep 2013, ANGO's subsidiary Navilyst Medical Inc. received 510(k) clearance from FDA for its BioFlo Port that is built with Endexo technology to bring down accumulation of catheter-related thrombus.

ANGO posted adjusted earnings of 6 cents per share for the second quarter of fiscal 2014 that not only ebbed sharply by 40% from 10 cents in the year-ago quarter but also missed the Zacks Consensus Estimate by a penny. Net adjusted earnings fell 34.5% to $2.3 million from $3.5 million a year ago.

Revenues inched up 2% to $88.6 million, marginally exceeding the Zacks Consensus Estimate of $88 million. Excluding the planned termination of the supply agreement with Boston Scientific Corp. BSX, revenues grew 3% to $87.0 million from $84.5 million in last year's quarter. Revenues from Vascular Access business dipped 4% to $25.6 million.

ANGO currently carries a Zacks Rank #2 (Buy). Other stocks in the medical instruments industry with a favorable Zacks Ranks include Cynosure Inc. CYNO and Natus Medical Inc. BABY. Both of them sport a Zacks Rank #1 (Strong Buy).