Waterjet Surgical Robot Receives FDA Approval for Prostate Cancer Treatment Study

September 12th, 2023 - PROCEPT BioRobotics (NASDAQ: PRCT), a company focused on the development of urological surgical solutions, announced that it has received an investigational device exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) for its development of the Aquablation waterjet therapy. This means that the company can review the safety and efficacy of its waterjet therapy in the treatment of prostate cancer.

PROCEPT BioRobotics plans to initiate a single-arm feasibility study in the U.S. The study will use only the single robotic arm of the robotic system to perform surgical operations without the need for other aids or human intervention. The purpose of the study is to validate the basic functionality and operational performance of the surgical robotic system, as well as its accuracy and stability for surgical operations. This study will provide fundamental data for subsequent research and clinical applications and will support future research and regulatory applications in the United States.

The study will enroll patients with limited prostate cancer at three prestigious cancer centers, including USC Keck Medical Center, the Perlmutter Cancer Center at NYU Langone Health and the Tisch Cancer Center at Mount Sinai. Dr. Inderbir Gill, founding executive director of USC's Division of Urology, said the proven efficacy and safety of Aquablation waterjet therapy in removing prostate tissue from patients with benign prostatic hyperplasia (BPH) offers a potential new approach to treating limited prostate cancer. With the unique ability to precisely eradicate prostate tissue, waterjet resection technology has the potential to effectively treat the cancer while ensuring the patient's quality of life. Reza Zadno, CEO of PROCEPT BioRobotics, said that the IDE approval of the Aquablation waterjet therapy is critical for men with limited prostate cancer. The company's primary goal is to establish a standard of care for treating patients with BPH, and the company's robotic system has unique potential to address other urologic indications as well. The Company hopes to gain clinical support for this study and to collaborate with some of the leading cancer physicians in the United States.

AquaBeam Robotic System

The AquaBeam Robotic System is an advanced, image-guided surgical robotic system developed by PROCEPT BioRobotics. This system is primarily used to deliver Aquablation waterjet therapy, a minimally invasive procedure used primarily to treat lower urinary tract symptoms (LUTS) caused by benign prostatic hyperplasia (BPH). During the procedure, the AquaBeam robotic system removes prostate tissue precisely and quickly by cutting with a stream of water following image guidance. This procedure does not require advanced medical skills or heat, and minimizes patient injury. The AquaBeam Robotic System provides significant symptomatic relief and reduces the risk of complications compared to other surgical procedures. 

The AquaBeam Robotic System operates as follows: first, the surgeon places an ultrasound scope into the rectum, and then an AquaBeam cystoscope is inserted into the bladder through the urethra. Next, the Aquabeam robotic arm will be attached to the handle of the cystoscope. The camera attached to the cystoscope, along with the imaging produced by the ultrasound probe, will be projected onto a large screen for the surgeon. 

Features of the AquaBeam robotic system include real-time, multidimensional imaging, which allows for individualized treatment planning for a patient's unique anatomy and real-time monitoring during surgery. The surgeon creates a map of the treatment area based on each patient's anatomy, which designates the area of the prostate to be removed while preserving the anatomy that controls erectile function and ejaculatory function.

Once the treatment map is complete, prostate tissue is precisely removed using a robotically controlled hot waterless knife. Robotics and waterjet technology allow for targeted and controlled tissue removal in a fraction of the removal time, accommodating different prostate sizes and shapes and reducing dependence on the surgeon's level of experience. 

Once activated, the AquaBeam robot will generate high-velocity, unheated, sterile saline water and follow a precise mapping plan outlined by the surgeon. During the treatment, the surgeon will have full visibility of the prostate, the removal process and control of the machine. At any point, the surgeon is able to immediately pause the procedure to make minor adjustments if necessary. 

Aquablation Waterjet Therapy

Aquablation waterjet therapy is offered by the AquaBeam robotic system developed by PROCEPT BioRobotics. This is an advanced, image-guided surgical robotic system that provides Aquablation Waterjet Therapy, a minimally invasive procedure for the treatment of Lower Urinary Tract Symptoms (LUTS) caused by Benign Prostatic Hyperplasia (BPH). During the procedure, the "waterjet" cuts with a stream of water guided by an image, removing prostate tissue precisely and quickly, without the need for advanced medical skills or heat, and minimizing patient injury.

PROCEPT BioRobotics, Inc.

PROCEPT BioRobotics, Inc. Founded in 2007 and headquartered in California, USA, PROCEPT BioRobotics focuses on the AQUABEAM robot for minimally invasive urological procedures. The company went public in September 2021. In February 2023, PROCEPT® BioRobotics announced financial results for the year ended December 31, 2022. Total revenues for the full year of 2022 were $75 million, an increase of 118% year-over-year, and the company expects to report total revenues of $125 million for 2023. The company is expected to report total revenues for the year ended December 31, 2022 of $75 million, a 118% increase year-over-year.