PROCEPT BioRobotics® Advances Prostate Cancer Program with WATER IV Study Enrollment Completion and Expanded IDE Approval

Rhea-AI Summary

PROCEPT BioRobotics (Nasdaq: PRCT) reported two key milestones in its WATER IV prostate cancer program: completion of enrollment in the randomized WATER IV RP study comparing Aquablation therapy with radical prostatectomy, and expanded FDA IDE approval for a second randomized WATER IV AS protocol versus active surveillance.

WATER IV RP has fully enrolled 280 patients, with primary endpoint results expected at the AUA Annual Meeting in spring 2027. WATER IV AS will enroll up to 333 patients and, along with WATER IV RP, will follow men for ten years to assess disease control and quality-of-life outcomes.

Positive

• Randomized WATER IV RP study fully enrolled with 280 prostate cancer patients
• FDA IDE approval granted for second randomized WATER IV AS protocol
• WATER IV AS planned enrollment of up to 333 patients globally
• Both WATER IV protocols include 10-year follow-up for long-term outcomes
• Primary endpoint results for WATER IV RP expected by spring 2027

Negative

• None.

Argus May 28 session

+2.80% close to close Open Argus

Details

News Market Reaction – PRCT

On May 28, the day this news came out, PRCT closed 2.80% above the previous close.

Data tracked by StockTitan Argus for the May 28 session.

Key Figures

WATER IV RP enrollment: 280 patients WATER IV AS enrollment cap: 333 patients Follow-up duration: 10 years +4 more

WATER IV RP enrollment

280 patients

First randomized study vs radical prostatectomy

WATER IV AS enrollment cap

333 patients

Second randomized study vs active surveillance

Follow-up duration

10 years

Patient follow-up in both randomized WATER IV protocols

Biopsy assessment

1 year

Biopsy-based assessment timepoint in WATER IV AS

MRI evaluation

3 years

MRI-based whole gland evaluation in WATER IV AS

Gland resection extent

>95% of gland

Aquablation robotic waterjet resection description

Prostate cancer grades

Grade Group 1 and 2

Patient risk profile in WATER IV AS trial

Historical Context

5 past events · Latest: May 14

5 events

1. May 14

   Guideline update

   24h Move

   +2.6%

   AUA guidelines strengthened Aquablation recommendation for a broad prostate size range.

2. Apr 30

   Investor conferences

   24h Move

   +2.5%

   Announcement of management presentations at three upcoming healthcare investor conferences.

3. Apr 29

   Earnings results

   24h Move

   +10.7%

   Q1 2026 results with 20% revenue growth and confirmed full-year guidance.

4. Apr 09

   Earnings date

   24h Move

   -0.3%

   Notification of Q1 2026 results release date and accompanying conference call.

5. Mar 23

   Guideline upgrade

   24h Move

   +0.9%

   EAU upgraded Aquablation to a strong surgical recommendation for BPH.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

investigational device exemption (ide), radical prostatectomy, active surveillance, biopsy, +2 more

6 terms

investigational device exemption (ide) regulatory

"FDA Investigational Device Exemption (IDE) approval for a second randomized protocol"

An investigational device exemption (IDE) is a regulatory permission that allows a medical device to be used in clinical studies so companies can gather safety and effectiveness data before full market approval. For investors, an IDE is a key milestone because it lets a company test real-world performance and move toward commercial clearance or approval—much like a trial run that, if successful, can unlock larger revenue opportunities and reduce regulatory risk.

radical prostatectomy medical

"randomized WATER IV study evaluating Aquablation therapy versus radical prostatectomy"

Radical prostatectomy is a surgical procedure that removes the entire prostate gland and some surrounding tissue to treat prostate cancer. For investors, it matters because changes in how often the surgery is done, improvements in related devices or techniques, or shifts toward alternative treatments can affect revenues and costs for hospitals, medical-device makers, insurers and drug developers—similar to how a shift from gas to electric engines reshapes industries tied to the old technology.

active surveillance medical

"evaluate Aquablation therapy versus active surveillance in men with Grade Group 1 and 2"

Active surveillance is a medical approach where a patient’s condition is closely monitored over time instead of starting immediate treatment, with therapy begun only if the condition shows signs of progression. For investors, this matters because it affects demand for drugs, diagnostics and follow-up services: a shift toward monitoring can increase sales of tests and imaging while delaying or reducing uptake of aggressive treatments, similar to choosing regular checkups instead of an immediate repair for a minor car issue.

biopsy medical

"Patients will be followed for ten years, including biopsy assessment at one year"

A biopsy is a medical procedure that removes a small piece of tissue or cells so a doctor can examine them under a microscope to see if disease, such as cancer or an infection, is present. For investors, biopsy results can change the outlook for drugs, diagnostics and medical devices—think of it like sampling a bite of food to decide whether the whole dish is safe; positive or negative findings can affect clinical trial success, approval chances, market demand and reimbursement decisions.

mri medical

"biopsy assessment at one year and MRI-based whole gland evaluation at three years"

Magnetic resonance imaging (MRI) is a medical scan that uses magnetic fields and radio waves to create detailed pictures of the inside of the body, like a high-resolution camera for tissues and organs. Investors care because MRI drives demand for imaging machines, hospital services, diagnostics and can be central to clinical trial results and regulatory decisions—changes in MRI use or technology can affect revenue, capital spending and reimbursement in healthcare and medical device markets.

transurethral medical

"Ultrasound-guided, transurethral robotic waterjet resection of the prostate"

Transurethral describes medical procedures or devices that are introduced through the urethra — the natural tube that carries urine out of the body — rather than by cutting through the skin. For investors, transurethral approaches matter because they often mean less-invasive treatments, shorter hospital stays and different regulatory, reimbursement and device-market dynamics than open surgery, which can affect sales, adoption and risk profiles of healthcare products.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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SAN JOSE, Calif., May 28, 2026 (GLOBE NEWSWIRE) -- PROCEPT BioRobotics (Nasdaq: PRCT) today announced two milestones in its WATER IV prostate cancer clinical program: completion of enrollment in the randomized WATER IV study evaluating Aquablation® therapy versus radical prostatectomy, and FDA Investigational Device Exemption (IDE) approval for a second randomized protocol evaluating Aquablation therapy versus active surveillance.

The first randomized WATER IV study (WATER IV RP) fully enrolled 280 planned patients and is the only FDA randomized study comparing Aquablation therapy to radical prostatectomy, the established surgical standard of care. Based on current timelines, the Company expects to present the WATER IV RP primary endpoint results at the American Urological Association (AUA) Annual Meeting in spring 2027.

The second randomized study in the WATER IV clinical program (WATER IV AS) will enroll up to 333 patients globally and evaluate Aquablation therapy versus active surveillance in men with Grade Group 1 and 2 prostate cancer. Active surveillance is commonly used for men with lower-risk prostate cancer to avoid the quality-of-life impact associated with radical treatment, although many patients ultimately progress to surgery or radiation over time. WATER IV AS is designed to evaluate whether Aquablation therapy may provide an earlier treatment option for men on active surveillance before the disease progresses further. Patients will be followed for ten years, including biopsy assessment at one year and MRI-based whole gland evaluation at three years.

“We are excited to complete enrollment in the first randomized WATER IV protocol, reflecting strong interest from physician investigators as well as patients in evaluating Aquablation as a new approach to prostate cancer treatment,” said Larry Wood, President and Chief Executive Officer of PROCEPT BioRobotics. “The IDE approval for the additional randomized WATER IV protocol enables us to evaluate whether earlier intervention with Aquablation may offer men on active surveillance a quality-of-life-preserving treatment option rather than waiting for the disease to progress.”

Both randomized WATER IV protocols will follow patients for ten years and are designed to evaluate the long-term experience of men with prostate cancer. The studies will assess both disease control and quality-of-life outcomes over time, including the impact of treatment on urinary, sexual, and overall function. No other prostate cancer therapy has been evaluated with such a level of rigor early in its development, reflecting the company’s continued commitment to advancing science and innovation in prostate care.

For more information on the WATER IV study, please visit: https://clinicaltrials.gov/study/NCT06651632

Figure: Aquablation Therapy for Prostate Cancer
Ultrasound-guided, transurethral robotic waterjet resection of the prostate designed to remove cancer, at-risk tissue, and any obstructive tissue resulting in >95% of the gland being resected leaving only the outer prostatic capsule intact.

About PROCEPT BioRobotics^® Corporation
PROCEPT BioRobotics is a surgical robotics company focused on advancing patient care by developing transformative solutions in urology. The Company manufactures the AQUABEAM^® and HYDROS® Robotic Systems. The HYDROS Robotic System is the only AI-powered, robotic technology that delivers Aquablation therapy. PROCEPT BioRobotics designed Aquablation therapy to deliver effective, safe, and durable outcomes for males suffering from lower urinary tract symptoms or LUTS, due to BPH that are independent of prostate size and shape or surgeon experience. In addition to its leadership in BPH treatment, the Company is pursuing clinical research initiatives in prostate cancer utilizing investigational applications of its robotic and AI-enabled technologies. BPH is the most common prostate disease and impacts approximately 40 million men in the United States. The Company has developed a significant and growing body of clinical evidence with approximately 250 peer-reviewed publications, supporting the benefits and clinical advantages of Aquablation therapy.

Forward-Looking Statements
This press release may contain forward-looking statements within the meaning of federal securities laws. Forward-looking statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from those anticipated or implied in such statements. PROCEPT BioRobotics undertakes no obligation to publicly update or revise any forward-looking statements.

Important Safety Information
All surgical treatments have inherent and associated side effects. For a list of potential side effects visit https://aquablation.com/safety-information/

Media Contact:
Kevin Waters
Executive VP, Chief Financial Officer
PROCEPT BioRobotics
k.waters@procept-biorobotics.com

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/4f4bd11e-cbd0-4365-8b2c-b55a77eb8bdd.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did PROCEPT BioRobotics (PRCT) announce about the WATER IV study on May 28, 2026?

PROCEPT BioRobotics announced completion of enrollment in the randomized WATER IV RP study and FDA IDE approval for a second WATER IV AS protocol. According to PROCEPT BioRobotics, both trials evaluate Aquablation therapy for prostate cancer against radical prostatectomy or active surveillance.

How many patients are enrolled in PROCEPT BioRobotics' WATER IV RP trial for prostate cancer (PRCT)?

The WATER IV RP trial has fully enrolled its planned 280 prostate cancer patients. According to PROCEPT BioRobotics, this randomized study compares Aquablation therapy to radical prostatectomy and will follow participants for ten years to measure disease control and quality-of-life outcomes.

What is the design of the WATER IV AS study in PROCEPT BioRobotics' (PRCT) prostate cancer program?

The WATER IV AS study will randomize up to 333 patients to Aquablation therapy or active surveillance. According to PROCEPT BioRobotics, it focuses on men with Grade Group 1 and 2 prostate cancer and includes ten-year follow-up with biopsy and MRI-based assessments.

When will PROCEPT BioRobotics (PRCT) report primary endpoint results from the WATER IV RP trial?

Primary endpoint results from the WATER IV RP trial are expected in spring 2027. According to PROCEPT BioRobotics, the data are planned for presentation at the American Urological Association Annual Meeting, offering early randomized evidence on Aquablation therapy versus radical prostatectomy.

What outcomes will the WATER IV prostate cancer studies track for PROCEPT BioRobotics (PRCT)?

The WATER IV studies will track long-term disease control and quality-of-life outcomes over ten years. According to PROCEPT BioRobotics, assessments include urinary, sexual, and overall function, plus biopsy at one year and MRI-based whole-gland evaluation at three years.

How does Aquablation therapy work in PROCEPT BioRobotics' (PRCT) WATER IV prostate cancer program?

Aquablation therapy uses ultrasound-guided, transurethral robotic waterjet resection of the prostate. According to PROCEPT BioRobotics, the approach targets cancer, at-risk, and obstructive tissue, aiming to resect over 95% of the gland while leaving the outer prostatic capsule intact.