The non-randomized pilot study will include six subjects at up to three sites and is designed to inform the design of a pivotal clinical study in the U.S. to help support the company’s bid for pre-market approval from the FDA.
“On the heels of our first patient enrollment in our Stage III pancreatic cancer IDE, we are excited to receive approval to conduct a separate pilot IDE for the treatment of prostate cancer,” SVP and oncology GM Brent Boucher said in prepared remarks. “This pilot study represents the next step in our comprehensive approach to establishing NanoKnife as a platform technology to treat numerous cancers and conditions.”
NanoKnife is a minimally invasive device used to treat focal prostate lesions through irreversible electroporation. It uses low-energy, direct-current electrical pulses to permanently open pores in target cell membranes. It recently won 510(k) clearance for the surgical ablation of soft tissue.