) announced that it has won the Investigational Device Exemption
(IDE) approval from the U.S. Food and Drug Administration (FDA).
The regulatory approval allows this provider of minimally
invasive medical devices to carry out a clinical study of the
NanoKnife System for the ablation of focal prostate cancer.
Following the approval, AngioDynamics is progressing with the
institutional review board (IRB) submissions for the clinical
study. The company plans to begin patient enrollment in the
second quarter of fiscal 2014 (ending Nov 30, 2013).
Meanwhile, AngioDynamics forged a partnership with the Clinical
Research Office of the Endourological Society (CROES).
Subsequently, the company is carrying out a clinical study to
demonstrate NanoKnife System's efficacy within the armamentarium
for low-intermediate localized prostate cancer. The study -
Multicenter Randomized Two-Arm Intervention Study Evaluating
Irreversible Electroporation for the Ablation of Localized
Unilateral Prostate Cancer
will enroll 200 patients across six European countries.
AngioDynamics' Oncology/Surgery business currently serves a $600
million market. While the company already has 7% market share,
positive data on NanoKnife that improves the adoption rates
should further support market share gain.
According to AngioDynamics, the demand for minimally invasive
technology in the urology space is soaring. Given this backdrop,
positive data from clinical studies that support the application
of NanoKnife for treatment of focal lesion within the prostate
should improve adoption of the company's technology. Management
will discuss this opportunity in details during the
fourth-quarter conference call.
Revenues from NanoKnife shot up 35% year over year to $2.7
million in the third quarter of fiscal 2013. The company also
witnessed considerable demand for its NanoKnife among urologists.
On the other hand, management is also working on expanding the
application of NanoKnife for focal treatment of pancreas cancer.
The expansion of NanoKnife's application to the large untapped
potential markets should foster growth for AngioDynamics.
Minimally invasive surgery is becoming increasingly popular in
helping patients reduce recovery time, thereby reducing
hospitalization costs. With an increasing number of patients and
physicians introducing the latest technology for surgical
procedures for cancer treatment, AngioDynamics is expected to
capture a sizeable market share of the minimally invasive surgery
market over the next few years.
However, AngioDynamics' softness in elective procedures, delayed
capital spending and persisting austerity measures in the market
continue to affect its top line. Further, intense competition and
pressure on gross margin remain matters of concern.
Currently, the stock carries a Zacks Rank #3 (Hold). While we
remain on the sidelines for AngioDynamics, we believe that other
medical stocks such as
Natus Medical Inc.
), carrying a Zacks Rank #1 (Strong Buy), warrants a look.
Heartware International Inc.
) are also worth considering. These stocks hold a Zacks Rank #2
ANGIODYNAMICS (ANGO): Free Stock Analysis
NATUS MEDICAL (BABY): Free Stock Analysis
CRYOLIFE INC (CRY): Free Stock Analysis
HEARTWARE INTL (HTWR): Free Stock Analysis
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