Procept BioRobotics (Nasdaq:PRCT) announced today that it received FDA investigational device exemption (IDE) for its Aquablation therapy.
The IDE allows Procept to initiate a single-arm feasibility study for the Aquablation prostate cancer therapy in the U.S. Data generated from the study could support future research and regulatory applications in the U.S. The company plans to enroll patients with localized prostate cancer across three cancer centers in the country.
Redwood City, California-based Procept says the study takes place at Keck Medical Center (California), Perlmutter Cancer Center at NYU Langone Health and Mount Sinai Tisch Cancer Center (both New York).
About the Procept BioRobotics Aquablation therapy
Dr. Inderbir Gill, founding executive director for USC Urology as part of Keck, said Aquablation therapy provides efficacy and safety. Gill said it “offers a potential paradigm shift in how urologists might address localized prostate cancer.
Aquablation uses waterjet resection to precisely eradicate prostate tissue. It provides the potential for an effective cancer treatment while maintaining the patient’s quality of life. The image-guided, automated, heat-free robotic therapy uses real-time ultrasound imaging. This provides the surgeon with a multi-dimensional view of the prostate.
The therapy enables personalized treatment planning tailored to each patient’s unique anatomy. Surgeons can specify the areas of the prostate to remove while preserving certain anatomies. Once they map treatment plans, the automated robot removes prostate tissue in a precise, targeted and controlled fashion.
“Receiving IDE approval to explore Aquablation therapy for men with localized prostate cancer marks a pivotal moment for Procept,” CEO Reza Zadno said. “While our primary commitment is to establish ourselves as the standard of care for the treatment of BPH, we acknowledge the distinctive potential of our robotic system to address other urological indications. Our aim is to bolster the clinical evidence through this study and collaborate with some of the nation’s foremost cancer physicians.”