AngioDynamics IDE Application for NanoKnife Gets FDA Nod

Zacks Equity Research Published on May 23, 2019

AngioDynamics, Inc. (ANGO - Free Report) recently announced FDA’s approval for the company’s investigational device exemption (IDE) application for its NanoKnife Irreversible Electroporation pilot study. Notably, the pilot study intends to support the approval of a future Premarket Approval Application (PMA) in the United States.

More Recent Approvals

It is encouraging to note that in recent times, the company has received more regulatory approvals.

In April 2019, the company received an approval from the FDA to initiate a clinical study for treating stage III pancreatic cancer. (Read More: AngioDynamics Gets FDA Nod to Begin NanoKnife DIRECT Study)

Earlier, the company had announced that FDA has granted an expanded 510(k) clearance for its OARtrac Radiation Dose Monitoring System for use in cancer treatments. (Read More: AngioDynamics' Latest FDA Approval to Boost Oncology Unit)

NanoKnife — A Key Catalyst

The NanoKnife System is a unique, minimally invasive technique that has been used to successfully treat focal prostate lesions through irreversible electroporation.

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.

Price Performance

We believe that such positive developments are likely to boost the Zacks Rank #4 (Sell) stock that has declined 6.2%, against the industry's 3% rise in a year’s time. The current level is also lower than the S&P 500 index’s 4.3% rise.

Key Picks

Some better-ranked stocks in the broader medical space are DENTSPLY SIRONA (XRAY - Free Report) , Penumbra (PEN - Free Report) and CONMED Corporation (CNMD - Free Report) , each carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

DENTSPLY’s long-term earnings growth rate is expected to be 11.5%.

Penumbra’s long-term earnings growth rate is projected at 21.5%.

CONMED’s long-term earnings growth rate is estimated at 13.3%.

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