) 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
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
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.
), 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
Natus Medical Inc.
). Both of them sport a Zacks Rank #1 (Strong Buy).
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