Client Need
PROCEPT BioRobotics is a medical robotics company focused on urology. It develops and sells image-guided surgical robotic systems for minimally invasive urologic procedures, especially for benign prostatic hyperplasia (BPH).
With the help of MCRA's Robotics, Japanese Regulatory and Reimbursement experts PROCEPT BioRobotics achieved Japanese regulatory approval for the Aquabeam Robotic System and a reimbursement category listing to improve patient accessibility.
MCRA Approach
MCRA Japan’s regulatory and reimbursement teams played a critical role assisting PROCEPT BioRobotics in gaining regulatory approval in Japan and establishing a new Category Reimbursement Listing Code.
MCRA THERAPY: Robotics
MCRA SERVICES: Japanese Regulatory and Reimbursement
Outcome
In February 2022, PROCEPT BioRobotics achieved regulatory approval for the Aquabeam Robotic System through strategic partnership with MCRA Japan.
Following regulatory approval, MCRA Japan led the reimbursement consultation and application process to establish a new reimbursement category listing in June 2023. MCRA Japan’s team worked diligently to navigate this reimbursement process to help PROCEPT achieve their goal and to provide patients with easily accessible care.
“We are very thankful to the entire MCRA Japan organization for guiding us through the process of establishing reimbursement in Japan. We view Japan as a very promising market for the adoption of Aquablation therapy, which has a long history of adopting new, innovative technologies, while prioritizing patient outcomes.”
