South Korea Approves AngioDynamics’ Nanoknife

Albany, N.Y.-based AngioDynamics Inc., which makes minimally invasive medical devices for vascular access, surgery, peripheral vascular disease and oncology, has earned approval for its Nanoknife system from South Korea’s Ministry of Food and Drug Safety (MFDS) for the ablation of soft tissue. The Nanoknife system uses a series of high-voltage, but low-energy electrical pulses, which are believed to 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,” said Joseph M. DeVivo, president and CEO of AngioDynamics. “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.”

AngioDynamics has already begun selling the Nanoknife system to healthcare providers in South Korea through exclusive distribution partnerships.

“The approval of Nanoknife in South Korea offers further evidence of the incredible value that this system can offer patients worldwide,” said Rick Stark, senior vice president of AngioDynamics’ global oncology/surgery franchise. “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.”

In the past 60 days, Nanoknife has been approved by four countries, including Malaysia, South Korea Thailand and Vietnam. Nanoknife generators are also approved in China. Nanoknife is now approved in 45 countries worldwide. In the United States, the Nanoknife System has received a 510(k) clearance by the U.S. Food and Drug Administration for use in the surgical ablation of soft tissue, and is similarly approved for commercialization in Canada, the European Union and Australia. In the United States, the Nanoknife System has not received clearance for the therapy or treatment of any specific disease or condition.