) announced the receipt of 510(k) clearance from the U.S. Food and
Drug Administration (FDA) for its Celerity tip location system. The
system will be used as a supplement to assist in the placement of
Peripherally Inserted Central Catheters (PICC) in adult patients.
The Celerity tip location system uses Electrocardiography or ECG
instead of chest X-ray and fluoroscopy to confirm the location of a
PICC. Following the approval, ANGO expects to initiate the U.S.
distribution of the system at the beginning of July this year.
In Mar 2014, the FDA rejected the initial 510(k) application for
the Celerity tip location system forwarded by Medcomp Inc., ANGO's
global distribution partner. Subsequently, ANGO executed an
agreement with Medcomp and Medcomp's development partner to gain
regulatory control over the Celerity platform and resolved to bring
the system to the U.S. market by mid-summer.
In Sep 2013, Medcomp received Health Canada's approval for the
commercial sale and distribution of its Celerity tip location
system in Canada. Circulation of the system in Canada was initiated
in Oct 2013. The Canadian market continues to see a positive market
response to the combined offering of the Celerity system with
ANGO's thrombus-resistant BioFlo PICC.
The Celerity system when combined with ANGO's BioFlo technology
provides unique clinical and economic advantages to the company.
Recently, ANGO also revealed that it has received 510(k) clearance
for its BioFlo DuraMax chronic hemodialysis catheter from the FDA,
marking the third U.S. clearance for its BioFlo product line-up in
the Vascular Access business.
The commercial launch of the catheter, which is expected in the
fourth quarter of fiscal 2014, is likely to boost ANGO's current
15% share in the $100 million U.S. chronic dialysis catheter
market. With the growing interest in thrombus-resistance PICCs,
ANGO's innovative BioFlo is becoming increasingly popular among
nephrologists and dialysis centers.
The novel BioFlo platform has successfully made a turnaround in the
company's Vascular Access business, which has been facing
considerable weakness for the last two years. The segment reflected
the first signs of growth in the last reported quarter. The
combined offering of the Celerity tip location system and the
BioFlo technology is poised to strengthen ANGO's Vascular Access
business over the long term.
ANGO currently carries a Zacks Rank #3 (Hold). Better-ranked stocks
in the medical instruments industry include
Alphatec Holdings, Inc.
RTI Surgical Inc.
). All these stocks sport a Zacks Rank #1 (Strong Buy).
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