(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.
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.
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.
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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