Growth Store

Technological Overview and Procedural Planning

• System Identification and Developer:

  • Developer: PROCEPT BioRobotics Corporation.

  • Robotic Platform: HYDROS™ Robotic System.

  • Core Therapeutic Procedure: Aquablation® Therapy.

  • Document Identification Code: ML0703.A.

• Intraoperative Procedural Steps (TRUS Guidance):

  • Transrectal Ultrasound (TRUS) Retraction: Retract the TRUS probe to accurately locate the mid-prostate and plan the treatment angle.

  • TRUS Advancement: If applicable, advance the TRUS probe to the median lobe for customized planning and targeting.

Clinical Need and BPH Treatment Modalities Comparison

• Unmet Need in Benign Prostatic Hyperplasia (BPH):

  • Maintaining safety and efficacy across prostates of all sizes and anatomical shapes.

  • Prostate Size Classification (based on AUA Guidelines 2023 Amendment and Tanneru et al., 2020):

    • Small Prostates: $30 - 40\,mL$

    • Medium Prostates: $40 - 80\,mL$

    • Large Prostates: $80 - 150\,mL$

    • Extra Large Prostates: $150\,mL+$

• Comparative Trade-offs of Traditional BPH Surgical Modalities:

  • Resective Modalities (TURP & PVP):

    • TURP = Transurethral Resection of the Prostate.

    • PVP = Photovaporization of the Prostate.

    • Trade-off: Prioritize symptom relief at the expense of sexual function and continence preservation.

  • Non-Resective / Enucleation & Simple MIST Modalities:

    • MIST = Minimally Invasive Surgical Technology.

    • Enucleation & Simple MIST: Prioritize sexual function and continence preservation at the expense of maximal symptom relief.

• Aquablation Therapy Solution:

  • Minimizes the clinical compromise across all prostate sizes ($30 - 40\,mL$, $40 - 80\,mL$, $80 - 150\,mL$, and $150\,mL+$).

  • Enables urologists to treat a broader patient population using a single surgical modality.

Adoption Metrics, Global Growth, and Market Expansion

• Global Procedure and Market Growth Metrics (2021–2024):

  • Compound Annual Growth Rate (CAGR): $98\%$ 3-year procedure growth from $2021$ to $2024$

  • Total Cumulative Global Procedures: $>70,000$ commercial and clinical procedures performed since $2018$

  • Global Installed Base: $\sim 650$ robotic systems installed globally since $2018$

  • Surgeon Adoption: $1,800+$ unique surgeons globally trained and performing Aquablation procedures since $2019$

  • Daily Surgical Rate: $130$ patients treated every weekday globally (calculated based on $2024$ procedure volume)

• Geographic Expansion and Availability:

  • Commercial Footprint: Approved and commercially available in $18$ countries globally:

    • Austria

    • Belgium

    • Canada

    • China

    • France

    • Germany

    • Hong Kong

    • Israel

    • Italy

    • Japan

    • Lebanon

    • Portugal

    • South Korea

    • Spain

    • Switzerland

    • Taiwan

    • United Arab Emirates (UAE)

    • United Kingdom (UK)

    • United States (US)

  • United States Infrastructure: $>445$ active U.S. Aquablation therapy programs established through Q3 $2024$

Operational Efficiencies, OR Throughput, and Economic Reimbursement

• Operating Room (OR) Efficiency and Operative Duration:

  • Provides predictable, low operative times of less than $1\text{ hour}$ ($<1\text{ hour}$) regardless of prostate size.

  • Demonstrates significantly reduced operative time variability compared to resective techniques such as GreenLight PVP, ThuLEP, GreenLEP, and HoLEP (Nguyen DD et al., 2020).

• Financial Reimbursement and Revenue Metrics:

  • Reimbursement Rate Advantage: Reimbursement for Aquablation therapy is $82\%$ higher than traditional TURP and laser ablation modalities (based on CMS Final Rule Making, CMS-1809-FC, November $2024$).

  • Ambulatory Payment Classifications (APC) Levels:

    • APC Payment Level 5: $\$5,083$

    • APC Payment Level 6 (Aquablation Therapy): $\$9,247$

  • OR Throughput Model (Stacked Cases): Performing $6$ stacked Aquablation cases in a single operative day yields $\$55,482$ in total Medicare reimbursement ($6 \times \$9,247 = \$55,482$).

• Epidemiological Demand and Market Opportunity:

  • Prescription Medication Population: Approximately $12\text{ Million}$ ($12\text{M}$) men are currently taking prescription medications for BPH (Vuichoud C & Loughlin KR, 2015).

  • Surgical Conversion Rate: Currently, only $\sim 1\%$ of diagnosed BPH patients transition to surgical interventions.

  • Demographic Growth Projection: An expected $\sim 32\%$ increase in the population of men aged $65+$ years (US Census Bureau $2022$ Projections) expands the underlying patient demand.

Clinical Outcomes, Safety Profile, and Efficacy Evidence

• Clinical Data Synthesis Baseline (18 Publications up to January 2025):

  • Total Aggregated Patient Population: $3,834$ patients

  • Mean Patient Age: $67$ years old

  • Prostate Volume Range Studied: $12 - 363\,mL$

  • Prevalence of Median Lobe: $60\%$ of patients

  • Patients in Urinary Retention at Baseline: $30\%$

• Distribution of Prostate Sizes Studied Across 18 Publications:

  • Prostates $<30\,mL$: $1$ study

  • Prostates $30 - 80\,mL$: $16$ studies

  • Prostates $80 - 150\,mL$: $13$ studies

  • Prostates $150+\,mL$: $7$ studies

• Efficacy and Durability (IPSS Metrics):

  • International Prostate Symptom Score (IPSS): Sustained dramatic improvement from baseline through $1\text{ year}$, $2\text{ years}$, $3\text{ years}$, $4\text{ years}$, and $5\text{ years}$.

  • Symptom Severity Shift: The vast majority of patients transition from severe baseline urinary symptoms ($IPSS \ge 20$) to mild post-procedure urinary symptoms ($IPSS \le 7$).

• Safety and Functional Preservation Profile (Weighted Averages & Medians with IQR):

  • Average Follow-up Duration: Weighted average $29$ months (Median: $12$ months, IQR: $4.5 - 13.5$ months)

  • Ejaculatory Dysfunction Rate: Weighted average $7.1\%$ (Median: $5\%$, IQR: $0 - 15\%$

  • Erectile Dysfunction Rate: Weighted average $0\%$ (Median: $0\%$, IQR: $0 - 0\%$

  • Urinary Incontinence Rate: Weighted average $0.2\%$ (Median: $0\%$, IQR: $0 - 0\%$

  • Blood Transfusion Rate: Weighted average $1.4\%$ (Median: $2\%$, IQR: $1 - 3\%$

  • Annual Surgical Retreatment Rate: Weighted average $0.5\%$ (Median: $0\%$, IQR: $0 - 1\%$

• Post-Operative Discharge Settings:

  • Surgical Center / Day Case: Discharge achievable in $\sim 5\text{ hours}$.

  • Outpatient Hospital: Discharge achievable in $<23\text{ hours}$.

Aggregated Meta-Analysis and 18 Key Clinical Studies

• Meta-Analysis Inclusion Criteria:

  • Included distinct patient cohorts evaluating Aquablation therapy from published studies up to January $2025$.

  • Excluded abstracts, unpublished data, and studies with sample sizes $n < 30$ (except focal technique reporting exceptions).

  • Outcomes were aggregated and weighted based on sample size.

• Detailed Summary of Included Clinical Publications:

  1. Desai et al. (India): Prostate volume range $20 - 118\,mL$, sample size $n=47$.

  2. Gilling et al. (WATER Study): Prostate volume range $30 - 80\,mL$, sample size $n=116$.

  3. Bhojani et al. (WATER II Study): Prostate volume range $80 - 150\,mL$, sample size $n=101$.

  4. Bach et al. (OPEN WATER Study): Prostate volume range $20 - 148\,mL$, sample size $n=178$.

  5. Misrai et al. (FRANCAIS WATER Study): Prostate volume range $30 - 80\,mL$, sample size $n=30$.

  6. Helfand et al. (Very Large Prostates): Prostate volume range $151 - 362\,mL$, sample size $n=36$.

  7. Kasraeian et al. (Jacksonville Study): Prostate volume range $27 - 223\,mL$, sample size $n=55$.

  8. Labban et al. (Lebanon Study): Prostate volume range $13 - 148\,mL$, sample size $n=59$.

  9. Burton et al. (Stanford AUR and CUR Study): Prostate volume range $29 - 250\,mL$, sample size $n=113$.

  10. Zorn et al. (Montreal ASC Study): Prostate volume range $41 - 270\,mL$, sample size $n=60$.

  11. Omidele et al. (Mount Sinai Study): Prostate volume range $38 - 330\,mL$, sample size $n=330$.

  12. Bach et al. (Hamburg Study): Prostate volume range $20 - 154\,mL$, sample size $n=118$.

  13. Hinata et al. (Japan PMS Study): Prostate volume range $33 - 242\,mL$, sample size $n=103$.

  14. Quintas et al. (Madrid Aquablation vs HoLEP Study): Prostate volume $72 \pm 35\,mL$, sample size $n=75$.

  15. Shvero et al. (Israel Study): Prostate volume range $31 - 138\,mL$, sample size $n=50$.

  16. Amparore et al. (Italy Study): Prostate volume range $43 - 81\,mL$, sample size $n=109$.

  17. Elterman et al. (Focal Bladder Neck Cautery Study): Prostate volume range $20 - 263\,mL$, sample size $n=2,089$.

  18. Gloger et al. (HoLEP vs Aquablation Hematuria Risk Study): Prostate volume $56 \pm 25\,mL$, sample size $$n=167$.

Safety Guidelines, Risk Information, and Regulatory Indications

• Device Status and Limitations:

  • Prescription Requirement: Rx Only.

  • Curative Claims: No claim is made that the Hydros™ Robotic System will cure any medical condition or entirely eliminate the diseased entity. Repeated treatment or alternative therapies may sometimes be required.

• Common Perioperative Adverse Events:

  • Mild, transient side effects include pelvic discomfort, dysuria (pain or difficulty urinating), hematuria (blood in urine), urinary frequency, urinary urgency, acute urinary retention, and urinary tract infections (UTIs) or bladder infections.

• Serious Potential Surgical Risks and Hazards:

  • Anesthesia-related risks.

  • Capsular Perforation: Bladder or prostate capsule perforation.

  • Structural Damage: Bladder neck contracture, urethral damage resulting in false passage or urethral stricture, rectal incontinence, or rectal perforation.

  • Systemic Hazards: Transurethral resection (TUR) syndrome, electric shock or electric burn, embolism, and bleeding/severe hematuria requiring intervention.

  • Functional & Sexual Adverse Events: Sexual dysfunction (ejaculatory dysfunction and erectile dysfunction), urinary incontinence, or overactive bladder.

• Corporate Trademarks:

  • Registered trademarks of PROCEPT BioRobotics Corporation include AQUABLATION, FistAssist AI, HYDROS, PROCEPT BioRobotics, and the PROCEPT BioRobotics logo.