Therapeutic and diagnostic devices maker,
) recently received 510(k) approval from the U.S. Food and Drug
Administration (FDA) for its BioFlo peripherally inserted central
catheters (PICCs) with Endexo technology. In comparison to other
commonly used PICCs, the BioFlo technology lowers the accumulation
of catheter-related thrombus, both outside and inside the catheter
by 87% on an average, based on platelet count.
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AngioDynamics plans to launch BioFlo PICCs in the second quarter of
fiscal 2013. These latest devices from the vascular access division
are the first of its kind to offer BioFlo technology in the U.S.
In addition, the permanent and non-eluting polymer, the Endexo
technology, renders long-term durability to BioFlo PICC and the
PASV Valve Technology design resists backflow, lowering blood
reflux that could lead to catheter-related complexities.
AngioDynamics is a market leader in several of its operating
segments including angiographic products and thrombolytic
catheters. It caters to 15% of the $375 million U.S. PICC market,
thereby holding the second spot in the region. The Access business
grew 8.5% to $18 million in the last reported quarter. The
availability of the advanced BioFlo PICC catheter with the PASV
Valve Technology will further boost the company's vascular access
The BioFlo PICC products have already received CE Mark and Canadian
approval along with other international approvals. Furthermore,
AngioDynamics plans to apply for FDA approval for its BioFlo ports
and BioFlo dialysis catheters product lines following the
successful Canadian launch of the BioFlo technology with PASV
Meanwhile, NanoKnife remains the life blood for AngioDynamics and
the company intends to expand the label to capitalize on its
commercial opportunities. The company is further ramping up
research and development (R&D) investment to expand its product
portfolio and support the ongoing clinical studies of NanoKnife and
vascular product development programs.
However, AngioDynamics' product lines face strong challenges from
the competitive offerings of larger rivals such as
). We currently have a Neutral recommendation on AngioDynamics,
which carries a short-term Zacks #3 Rank (Hold).