AngioDynamics Gets FDA Nod To Begin NanoKnife DIRECT Study
Zacks Investment Research | Apr 01, 2019 10:20PM ET
AngioDynamics, Inc. (NASDAQ:ANGO) announced that it has received an approval from the U.S. FDA to initiate a clinical study for treating stage III pancreatic cancer. The approval is for an investigational device exemption (IDE) application for NanoKnife Irreversible Electroporation “Direct IRE Cancer Treatment” clinical study (DIRECT).
Investors should notice that NanoKnife is one of the flagship products of AngioDynamics. It is a major top-line contributor of the company’s Oncology business.
What is IDE?
An IDE allows the investigational device to be used in a clinical study for ensuring safety and effectiveness of data (NanoKnife is the investigational device in this case). Clinical studies support a premarket approval application or a 510k submission to the FDA.
More About DIRECT
Coming back to the news, the DIRECT clinical study is expected to demonstrate comprehensive data collection strategy for clinicians, patients, payors and other stakeholders for the treatment of Stage III pancreatic cancer. Notably, the study is classified as a Category B IDE by the FDA. Its primary endpoint is overall survival of a patient participating in the study.
It is interesting to note that AngioDynamics is launching AngioDIRECT.com for enrolling participants as part of the DIRECT clinical study. The study is expected to open up a new path for an alternative treatment option for advanced pancreatic cancer.
NanoKnife – A Key Catalyst
The FDA had already granted the NanoKnife System a Breakthrough Device Designation under the 21st Century Cures Act, in January 2018.
For the surgical ablation of the soft tissue, NanoKnife has previously received a clearance from the FDA. The system utilizes low-energy direct current electrical pulses to permanently open pores in target cell membranes.
In the second quarter of fiscal 2019, NanoKnife revenues grew 29.1% year over year on increasing global adoption of the technology.
AngioDynamics, Inc. Price and Consensus
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