AngioDynamics FDA clearance for prostate tissue ablation

 AngioDynamics has won US Food and Drug Administration (FDA) clearance for its NanoKnife system to be used in prostate cancer patients.

The system, which was already FDA-cleared for the surgical ablation of soft tissue, is now indicated for prostate tissue ablation.

Shares in the US company opened 6.2% higher at market open on 9 December following the news compared to a pre-announcement market close. AngioDynamics has a market cap of $354m.

The NanoKnife system uses an approach called irreversible electroporation (IRE), which employs electrical pulses to destroy cancer cells and offers several safety advantages over other techniques such as thermal ablation. The high-voltage pulses in IRE create permanent nanopores in membranes of cancer cells, inducing apoptotic-like cellular death in the target tissue. NanoKnife treatment involves no knives, with the electric current passed through needles instead.

The FDA based its decision on data from AngioDynamics’ pivotal PRESERVE study. The trial met its primary effectiveness endpoint demonstrating the performance of the NanoKnife System for the ablation of prostate tissue in patients at intermediate risk of the disease.

In the US in 2021, 236,659 new prostate cancers were reported. The disease is one of the most common cancers in men, though is treatable if caught early.

At the one-year mark following the procedure, 84% of men were free from clinically significant disease. In addition, NanoKnife led to improved quality of life outcomes, such as short-term urinary continence and the ability to maintain erections. Conventional radical surgery or radiotherapy often results in significant dysfunction in urinary continence and erectile potency, according to the company. AngioDynamics stated the results consolidates previous safety and efficacy evidence from more than 32 clinical studies in over 2,600 patients.

AngioDynamics’ CEO Jim Clemmer said: “This milestone is the first step in recognising our vision to become the standard, function-preserving treatment for men with prostate tumours. As we expand our global footprint and increase access to our technology, we are launching comprehensive education and awareness campaigns to empower physicians with hands-on training and clinical support while engaging patients through innovative outreach initiatives.”

https://finance.yahoo.com/news/nanoknife-gains-fda-clearance-prostate-180334956.html