AquaBeam Robotic System
FDA-cleared surgical robot for BPH treatment
Device · On PremiseCompany source
Company profile
About Procept BioRobotics
PROCEPT BioRobotics is a surgical robotics company revolutionizing the treatment of benign prostatic hyperplasia (BPH) through advanced AI-powered robotic platforms. The company's mission is to empower men to choose better health without fear of compromise by delivering best-in-class robotic solutions that positively impact patients and drive value in partnership with urologists globally. The company's flagship technology, Aquablation therapy, is delivered through two robotic platforms: the next-generation HYDROS Robotic System and the AquaBeam Robotic System. Aquablation therapy is the only ultrasound-guided, robotic-assisted, waterjet treatment for BPH that has been FDA-cleared. The technology uses computer-assisted treatment planning with AI capabilities (FirstAssist AI) to maximize tissue resection while preserving important anatomical structures associated with sexual and urinary function. Clinical evidence from four major studies (WATER, WATER II, OPEN WATER, and JAPAN PMS) demonstrates that Aquablation therapy delivers safe, effective, and durable results across prostates of all shapes and sizes (20-242 mL). The therapy has shown superior safety profiles compared to traditional TURP procedures, with significantly lower rates of irreversible complications such as erectile and ejaculatory dysfunction, while maintaining comparable or superior efficacy in symptom reduction and quality-of-life improvement. The company serves healthcare providers, government hospitals, and health systems worldwide, with a vision to restore patient lives by delivering the BPH treatment of choice.
Company description Procept BioRobotics official website
Primary marketSurgical AI & Robotics
Commercial modelCommercial information available on request
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01 · Operating footprint
Where the Company operates
Company-profile context for clinical focus, customers, deployment, integration, milestones, and partnerships.
Clinical focus
- Benign Prostatic Hyperplasia (BPH)
- Lower urinary tract symptoms (LUTS)
Who it serves
- Government Hospitals
- Health Systems
- Healthcare Providers
- Urologists
Deployment & integration
Embedded · On Premise deployment with recorded integration context.
Geographic context
MarketsGlobal markets · Japan · United States
Company sourceOfficial website
Company milestones
Platform expansion
Launch of next-generation HYDROS Robotic System with AI-powered capabilities. Completion of multiple real-world studies (OPEN WATER, JAPAN PMS) validating clinical outcomes in commercial settings.
Partnerships
Recorded partners
No partners are currently listed.
02 · Flagship portfolio
Products, workflows, and platform capabilities
Selected source-backed Company products and the available commercial context.
Aquablation Therapy
Ultrasound-guided, robotic-assisted waterjet treatment for BPH
Service · On PremiseCompany source
FirstAssist AI
AI technology integrated into HYDROS Robotic System
Software · EmbeddedCompany source
HYDROS Robotic System
Next-generation, AI-powered robotic platform for Aquablation therapy
Device · On PremiseCompany source
03 · Research intelligence
Research Intelligence evidence
Publications, preprints, clinical validation, and regulatory records in Evidence Position order.
Evidence position
Publications, clinical validation, and regulatory records connected to this Company appear here.
Research
Publications & preprints
Which Anatomic Structures Should Be Preserved During Aquablation Contour Planning to Optimize Ejaculatory Function? A Case-control Study Using Ultrasound Video Recordings to Identify Surgical Predictors of Postoperative Anejaculation.Urology · Jul 1, 2021
How I do it: Balloon tamponade of prostatic fossa following Aquablation.The Canadian journal of urology · Aug 1, 2017
Clinical validation
Clinical-trial records
Use of PuraStat Following Aquablation to Determine if There is Change in Hematuria & Probability of Same Day DischargeNCT07789041 · Sponsor · RECRUITING
WATER IV PCa (AS Sub-study)NCT07650448 · Sponsor · NOT YET RECRUITING
Regulatory
Regulatory records
HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000)K251082 · 510k · Oct 10, 2025
HYDROS Robotic System; HYDROS TRUS Probe; HYDROS HandpieceK240200 · 510k · Aug 20, 2024
04 · Company-reported outcomes
Outcomes and case studies
Company-reported outcomes and customer stories are distinct from linked Research Intelligence evidence.
Low rates of irreversible complications (erectile dysfunction, ejaculatory dysfunction, incontinence)
Across four major clinical studies with varying prostate sizes
Superior safety vs TURP
WATER study demonstrated significantly reduced irreversible complications
Noninferior to superior efficacy vs TURP
Symptom reduction (IPSS), quality of life improvement, urinary flow rates
Durable results
5-year follow-up data showing sustained symptom relief and low retreatment rates
Size and shape independence
Effective across prostates 20-242mL in clinical studies
WATER Study (Multi-center Clinical Trial)
Double-blind, prospective, randomized controlled clinical trial comparing Aquablation therapy to TURP for treating BPH in prostates 30-80 mL
Superior safety and noninferior efficacy to TURP; significantly reduced rate of irreversible complications driven by ejaculatory dysfunction; for prostates above 50 mL, superior in both safety and symptom reduction; durable outcomes out to 5 years
JAPAN PMS Study (Multi-center Real-World)
Prospective, multicenter, real-world study in commercial setting for prostates 33-242 mL
Validated clinical study outcomes in real-world setting; supported size and shape independence of therapy
OPEN WATER Study (Multi-center Real-World)
Prospective, multicenter, real-world study in commercial setting for prostates 20-150 mL
Validated clinical study outcomes in real-world setting; supported size and shape independence of therapy
WATER II Study (Multi-center Clinical Trial)
Single-arm, prospective clinical trial evaluating Aquablation therapy on large prostates (80-150 mL)
Significantly improved symptom scores and urinary flow rates; only successfully completed study to assess treatment among large prostates; durable outcomes out to 5 years
05 · Leadership
Leadership team
Leadership profiles and professional links from the current Company record.
No active leadership profiles are currently listed.
06 · Company updates
Updates from Procept BioRobotics
Recent articles published on Procept BioRobotics's official website.
07 · HAIC coverage
Coverage and analysis
Health AI Central reporting that mentions this Company.
No HAIC coverage is currently linked to this Company.
08 · Official presence
Company sources and channels
Curated official destinations from the active Company record.
09 · Market pathway
Additional Companies in this Market
Other active Companies in the same market, selected alphabetically from the HAIC directory.
Market context
Surgical AI & Robotics
Companies developing surgical technologies enhanced by AI, including robotic surgical systems, AI-powered surgical assistance and navigation tools, autonomous surgical robotics, and surgical data and analytics platforms. Covers both the performance of surgery and the analysis of surgical outcomes and OR efficiency.
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Linked research, clinical, and regulatory source pathways.
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Record-level provenance and review context.