PROCEPT BioRobotics Corp. is a commercial-stage surgical robotics company, which engages in the development of transformative solutions in urology. It manufactures and sells the AquaBeam Robotic System, an image-guided, surgical robotic system for use in minimally invasive urologic surgery, with an initial focus on treating BPH. The firm's proprietary AquaBeam Robotic System employs a single-use disposable handpiece to deliver its Aquablation therapy, which combines real-time, multidimensional imaging, personalized treatment planning, automated robotics and heat-free waterjet ablation for targeted and rapid removal of prostate tissue. The company was founded by Nikolai Aljuri and Rodney C. Perkins in 2007 and is headquartered in San Jose, CA.
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- PROCEPT BioRobotics completed enrollment of 280 patients in the WATER IV RP study, the first FDA randomized trial comparing Aquablation therapy to radical prostatectomy for prostate cancer treatment. - The FDA granted investigational device exemption approval for a second randomized WATER IV AS study that will evaluate Aquablation therapy versus active surveillance in up to 333 patients with Grade Group 1 and 2 prostate cancer. - Both studies will follow patients for ten years to assess disease control and quality-of-life outcomes, with primary endpoint results from the first study expected at the 2027 American Urological Association Annual Meeting. - Aquablation therapy uses ultrasound-guided robotic waterjet technology to remove more than 95% of prostate tissue while preserving the outer prostatic capsule, potentially offering a quality-of-life-preserving treatment option.
- The European Association of Urology (EAU) has upgraded Aquablation therapy to a strong recommendation as a surgical treatment option for men with benign prostatic hyperplasia (BPH). - The guidelines now strongly recommend offering Aquablation therapy as an alternative to transurethral resection of the prostate (TURP) for men with moderate-to-severe urinary symptoms due to BPH. - This upgrade is particularly significant for patients interested in preserving ejaculatory function and reflects strong evidence quality from multiple clinical trials. - PROCEPT BioRobotics has also announced the international launch of the HYDROS Robotic System, the first AI-enabled robotic platform designed specifically for delivering Aquablation therapy.
- East Valley Urology completed the first three prostate cancer procedures in PROCEPT BioRobotics' FDA-approved WATER IV trial using Aquablation therapy in an ambulatory surgery center setting. - The outpatient procedures were performed without complications and achieved same-day discharge, demonstrating potential for more scalable and cost-effective prostate cancer treatment. - The WATER IV trial compares Aquablation therapy to radical prostatectomy in men with localized prostate cancer (grade group 1 to 3). - Aquablation therapy uses robotically controlled waterjet technology to remove prostate tissue while potentially preserving erectile, ejaculatory, and continence functions.
- The WATER III randomized clinical trial demonstrated that Aquablation therapy provides similar symptom relief to laser enucleation for treating benign prostatic hyperplasia (BPH) in large prostates (80-180mL). - Patients who underwent Aquablation showed significantly lower rates of ejaculatory dysfunction (14.8% vs 77.1%) and stress incontinence (0% vs 9.1%) compared to those who received laser enucleation treatment. - The three-month data revealed comparable International Prostate Symptom Score improvements between both treatments, though laser enucleation showed greater improvements in urinary flow rate and post-void residual reduction.
- The FDA has approved an IDE trial comparing Aquablation therapy to radical prostatectomy for localized prostate cancer. - The WATER IV PCa trial will enroll 280 patients with Grade Group 1-3 localized prostate cancer across 50 sites. - The study's primary endpoint is morbidity at 6 months, with long-term follow-up on treatment-related harm and oncologic events. - Aquablation, already approved for BPH, aims to improve safety and quality of life outcomes compared to prostatectomy.
