AngioDynamics (NSDQ:ANGO) said today it won approval from South Korea’s Ministry of Food and Drug Safety for its NanoKnife system designed to ablate soft tissue.
The NanoKnife system uses high-voltage, low-energy electrical pulses which AngioDynamics said can permanently open pores in cell membranes.
“As we discussed in our recent earnings call, we have been aggressively registering NanoKnife in countries around the world since receiving our Certificates to Foreign Governments three months ago, and this approval in South Korea is just the latest in a series of approvals. The global demand for this product grows as new clinical evidence shows the benefits that NanoKnife can offer to patients, providers and payers. It is a novel technology that has the potential to disrupt the healthcare system’s expectations for care,” CEO Joseph M. DeVivo said in a press release.
The Albany, N.Y.-based company said its NanoKnife has been approved in Malaysia, South Korea, Thailand and Vietnam in the past 60 days. The device has also won approval in China and has been cleared by the FDA.
AngioDynamics said the NanoKnife is commercially available in South Korea through exclusive distribution partners.
“The approval of NanoKnife in South Korea offers further evidence of the incredible value that this system can offer patients worldwide. We have already seen a positive response from customers. The opportunities for us in Asia are tremendous, and the approval of NanoKnife in South Korea continues to expand our market potential,” global oncology and surgery franchise senior veep Rick Stark said in prepared remarks.
In August, AngioDynamics said that data from the Star trial the NanoKnife minimally invasive soft tissue ablation device showed it may prolong the lifespan of pancreatic cancer patients.
The study has been published in the Annals of Surgery, according to AngioDynamics.
The 200-patient trial examined individuals with locally advanced pancreatic cancer treated with irreversible electroporation with the NanoKnife. Of the patients, 50 were also treated with pancreatic resection in addition to IRE.
All patients in the study underwent induction chemotherapy, with 52% receiving chemo-radiation prior to IRE. Of the patients treated, 37% sustained median grade 2 complications and 3% experienced local recurrence, the company said. Median survival in both groups was 24.9 months.
