Vision Deck

• Aquablation therapy is a robotic-assisted, heat-free waterjet surgical platform developed by PROCEPT BioRobotics Corporation for the treatment of Benign Prostatic Hyperplasia (BPH).

• Clinical Value Breakdown across Stakeholders:

  • Patient Value: Superior clinical safety profile compared to Transurethral Resection of the Prostate (TURP), supported by $5\text{-year}$ randomized clinical trial data (WATER trial).

  • Hospital Value: Features dedicated reimbursement codes and delivers predictable procedure execution times.

  • Surgeon Value: Enables treatment of prostates across all shapes and sizes, expanding the treatable patient population using a single modality.

• Global Platform Adoption and Market Traction (as of Q2 2024):

  • Commercial launch took place in Q1 2021 in the United States.

  • Recognized as one of the fastest-growing surgical robotics platforms in medical history.

  • Over $400$ AquaBeam and Hydros systems installed across the United States.

  • Over $1,000$ urologists trained.

  • Over $50,000$ patients treated globally.

Regulatory Clearances, Clinical Guidelines, and Commercial Timeline

• 2017: Initial FDA Clearance achieved for Aquablation therapy.

• 2018: Medicare coverage established across all Medicare Administrative Contractors (MACs).

• 2019: Official commercial launch in the United States.

• 2020: Inclusion in clinical practice guidelines by the National Institute for Health and Care Excellence (NICE) and the Canadian Urological Association (CUA).

• 2021: Inclusion in the American Urological Association (AUA) Guidelines.

• 2022: Inclusion in the European Association of Urology (EAU) Guidelines.

• 2023: Placement of the $400\text{th}$ AquaBeam system in the United States.

• 2024: FDA Clearance of the next-generation Aquablation therapy platform, the Hydros Robotic System. Achieved commercial payer coverage spanning $95\%$ of U.S. men.

Hydros Robotic System Architecture and Technological Features

• Robotic Resection:

  • Utilizes a robotic-assisted, heat-free waterjet to resect obstructive prostate tissue according to a pre-defined intraoperative treatment plan.

  • Designed to maximize tissue resection while protecting surrounding critical anatomical structures, enabling efficient and predictable resections.

• Streamlined Operating Room Workflow:

  • Single-footprint tower design integrating imaging and robotic control.

  • Facilitates rapid operating room setup and minimizes turnover time between cases.

• Artificial Intelligence Integration (FirstAssist AI™):

  • Developed using real-world Aquablation therapy procedure data, expert surgical input, and image recognition software.

  • Assists urologists in real-time identification of critical anatomy on ultrasound imaging.

  • Recommends an optimal, patient-specific treatment plan.

• Advanced Dual Image Guidance:

  • Combines real-time intraoperative transrectal ultrasound with direct intraoperative cystoscopic visualization.

  • Provides full, detailed visualization of prostate anatomy and critical boundary structures.

Epidemiology and BPH Market Dynamics

• Disease Prevalence and Demographics:

  • Benign Prostatic Hyperplasia is the number one reason men visit a urologist.

  • Approximately $40,000,000$ men in the United States live with BPH, a number expected to rise over the next decade.

  • Age-Specific Prevalence:

  • $50\%$ of men aged $51\text{ to }60$ years have BPH.

  • $90\%$ of men aged $80\text{ to }90$ years suffer from BPH.

  • Aging Population Trajectory (2022 to 2035 U.S. Census projections):

  • Anticipated $32\%$ increase in U.S. men aged $65$ years and older over the next decade.

  • Requires a predictable and efficient surgical solution to aid hospitals in keeping up with growing treatment demand.

• Active BPH Patient Population Breakdown ($12,000,000+$ U.S. Men Actively Managed Annually):

  • Watchful Waiting ($4,300,000$ men): Choose no active intervention and continue to suffer BPH symptoms.

  • Pharmaceuticals ($6,700,000$ men): Suffer ongoing dosing adjustments and medication side effects.

  • Pharmaceutical Fallout ($1,100,000$ men): Experience medication failure or intolerance but delay surgery.

  • Surgical Interventions ($400,000$ surgeries per year): Undergo traditional surgical procedures, often compromising between safety and efficacy outcomes.

  • Underserved Opportunity: Comprises $1,500,000$ men annually ($1,100,000$ pharmaceutical fallouts combined with $400,000$ surgical candidates).

• Patient Hesitancy and Clinical Unmet Needs:

  • $97\%$ of men treated by a urologist do not seek surgical intervention due to treatment option limitations.

  • $83\%$ of men state they are unwilling to sacrifice sexual function (ejaculatory or erectile function) for symptom relief.

Comparative Analysis of Surgical Modalities and Complications

• Transurethral Resection of the Prostate (TURP):

  • General Prostate Size Treated: $<80\,mL$

  • Primary Category: Resective modality prioritizing symptom relief over side effect preservation.

  • Reported Complication Rates: Incontinence as high as $2\%$, Erectile Dysfunction (ED) as high as $14\%$, Ejaculatory Dysfunction (EjD) as high as $89\%$.

• Photovaporization of the Prostate (PVP):

  • General Prostate Size Treated: $<80\,mL$

  • Primary Category: Resective modality.

  • Reported Complication Rates: Incontinence as high as $2\%$, Erectile Dysfunction as high as $20\%$, Ejaculatory Dysfunction as high as $50\%$.

• Holmium/Thulium Laser Enucleation (Enucleation):

  • General Prostate Size Treated: $>80\,mL$

  • Primary Category: Resective modality for larger glands.

  • Reported Complication Rates: Incontinence as high as $33\%$, Erectile Dysfunction as high as $8\%$, Ejaculatory Dysfunction as high as $77\%$.

• Simple Prostatectomy:

  • General Prostate Size Treated: $>100\,mL$

  • Primary Category: Invasive resective procedure for large/very large glands.

  • Reported Complication Rates: Incontinence as high as $8\%$, Erectile Dysfunction as high as $3\%$, Ejaculatory Dysfunction as high as $90\%$.

• Minimally Invasive Surgical Technologies (MIST) / Non-Resective Modalities:

  • Focus: Prioritize sexual function and continence preservation, but restricted to small prostate volumes ($30\text{--}40\,mL$) and limited in resective efficacy.

• Aquablation Modality Unification:

  • Minimizes trade-offs across all prostate volumes:

  • Small ($30\text{--}40\,mL$)

  • Medium ($40\text{--}80\,mL$)

  • Large ($80\text{--}150\,mL$)

  • Extra Large ($150\,mL+$)

  • Allows urologists to treat prostates of all shapes and sizes ($20\text{ to }242\,mL$ demonstrated in trials) with a single robotic modality.

Clinical Trial Evidence Portfolio and Efficacy Data

• Key Trial Portfolio Summaries:

  • WATER Study ($5\text{-year}$ outcomes): Double-blind, randomized controlled trial comparing Aquablation therapy to TURP in prostates $30\text{ to }80\,mL$ (with explicit subgroup data for $50\text{ to }80\,mL$).

  • WATER II Study ($5\text{-year}$ outcomes): Prospective trial evaluating Aquablation therapy in large prostates ($80\text{ to }150\,mL$).

  • $1\text{-Year}$ Results Portfolio: Demonstrated efficacy in prostates $20\text{ to }150\,mL$

  • $3\text{-Month}$ Results Portfolio: Demonstrated efficacy in prostates $20\text{ to }242\,mL$

• Core Efficacy & Durability Findings:

  • Significant symptom score reduction from "Severe" to "Mild" as measured by the International Prostate Symptom Score (IPSS).

  • Durable symptom relief with low retreatment rates at $5\text{ years}$ post-procedure in small, medium, and large prostates.

  • Superiority vs. TURP (WATER Study $5\text{-Year}$ Data):

  • $51\%$ fewer patients returning to BPH medications or requiring a secondary surgical procedure compared to TURP.

  • Superior safety profile and low incidence of irreversible complications.

• Execution Consistency:

  • Robotic automation reduces variability in tissue resection times regardless of prostate size or surgeon experience.

  • Validated in trials where participating surgeons were experienced TURP surgeons with no prior Aquablation experience.

Health Economics, Coding, and Hospital Program ROI

• System Acquisition and ROI Metrics:

  • Capital acquisition cost: $<\$600,000$

  • Higher facility reimbursement: $78\%$ higher payment rate than TURP or laser procedures.

• Dedicated Coding Structure:

  • Only BPH robotic platform with dedicated reimbursement coding.

  • Dedicated Codes: CPT $0421T$, HCPCS $C2596$

  • Category I CPT Code: Approved by the AMA CPT Editorial Panel, with scheduled go-live implementation on January 1, 2026.

• Payer Coverage Landscape ($\approx 95\%$ of U.S. Men Covered):

  • Medicare: Covered by all $7$ Medicare Administrative Contractors (MACs).

  • Medicare Advantage: Required to maintain coverage parity with traditional Medicare.

  • Commercial Payers: Covered by all major national insurance carriers and most regional insurers.

• Facility Outpatient Payment Comparison ($2024$ Medicare Outpatient Prospective Payment System Addendum A):

  • TURP & Laser Modalities: $\$4,935$

  • Aquablation Therapy: $\$8,787$

• Top Institutional Adoption & Case Study:

  • Top U.S. Programs: $8$ out of the top $10$ Urology Hospitals in the U.S. (per U.S. News & World Report 2024 Best Hospitals for Urology rankings) maintain an active Aquablation program.

  • Mid-Atlantic Regional Health System Case Study:

  • Program achieved an increase of $58$ procedures within the first $8\text{ months}$ post-launch.

  • Drivers of growth: Successful treatment of larger prostate volumes, conversion of drug-managed patients to durable surgical intervention, and utilization of surgical robotics for physician recruitment.

Risk and Safety Information

• Common and Transient Adverse Events:

  • Dysuria or mild pain/difficulty during micturition.

  • Pelvic or penile discomfort.

  • Hematuria (blood in urine).

  • Urinary retention or inability to empty the bladder.

  • Increased urinary frequency and urgency.

  • Bladder infection or Urinary Tract Infection (UTI).

• General Surgical and Perioperative Risks:

  • Sexual dysfunction, including ejaculatory dysfunction and erectile dysfunction.

  • Perforation of the bladder neck or prostate capsule.

  • Bladder neck contracture.

  • Urethral trauma causing false passage or urethral stricture.

  • Rectal perforation or rectal incontinence.

  • Transurethral Resection (TUR) syndrome.

  • Electric shock or thermal burn injuries.

  • Overactive bladder or persistent urinary incontinence.

  • Thromboembolism.

  • Anesthesia-related risks and bloodborne pathogen transmission.

• Device Disclaimer:

  • Rx Only.

  • No claim is made that the Hydros Robotic System will cure any medical condition or completely eliminate diseased prostate tissue; repeat treatments or secondary alternative therapies may be required.