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.
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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.
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By GlobalDataAt 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.”
AngioDynamics’ technology is already being used on England’s NHS for prostate cancer patients, with the first procedure being conducted in 2022. UCLH consultant urologist Alistair Grey, who led the procedure on the first patients, said: “What is very exciting about this treatment is its precision in targeting and attacking the cancerous cells without damaging healthy tissue and maintaining the prostate’s important functions.”
AngioDynamics teamed up with the University College London Hospital (UCLH) in October to launch a UK prospective registry study evaluating the long-term effects of the NanoKnife system for treating unifocal intermediate-risk prostate cancer.
