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PROCEPT BioRobotics Announces New CPT Category I Code from the American Medical Association for Aquablation therapy

Key Takeaway: PROCEPT BioRobotics has announced that the American Medical Association has established a new Category I CPT code for Aquablation therapy, set to take effect on January 1, 2026. This decision was made due to the rising utilization of the therapy and its strong clinical evidence. The new code replaces the existing Category III code and signifies a notable advancement in the reimbursement framework for the procedure, which is designed to treat benign prostatic hyperplasia effectively and safely.

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POSITIVE FACTORS

  • New Category I CPT code for Aquablation therapy enhances reimbursement prospects.
  • Approval indicates the increasing acceptance and clinical validation of Aquablation therapy.
  • The therapy has shown effective and durable outcomes for patients with BPH.

Full Press Release Details

SAN JOSE, Calif., June 17, 2024 (GLOBE NEWSWIRE) -- PROCEPT BioRobotics® Corporation (Nasdaq: PRCT) (the “Company”), a surgical robotics company focused on advancing patient care by developing transformative solutions in urology, announced today that the American Medical Association (“AMA”) has established a new Current Procedural Terminology (“CPT”) Category I code for transurethral waterjet resection of prostate tissue (“Aquablation therapy”) to treat benign prostatic hyperplasia (“BPH”).
In response to increased utilization of Aquablation therapy and strong evidence for its clinical outcomes, the AMA accepted PROCEPT BioRobotics’ application for a Category I CPT code, which will replace the existing Category III CPT code starting January 1, 2026. In the meantime, U.S. hospitals and physicians performing Aquablation therapy procedures should continue to utilize the existing Category III code, 0421T.
“We are pleased that Aquablation therapy was approved by the AMA’s CPT® Editorial Panel for Category I code status,” said Reza Zadno, CEO of PROCEPT BioRobotics. “The Category I code designation is a testament to the widespread adoption, safety and effectiveness of Aquablation therapy in treating BPH. We greatly appreciate the support and guidance the American Urological Association provided throughout this process.”
About Aquablation Therapy
Aquablation therapy is the first and only ultrasound guided, robotic-assisted, heat-free waterjet for the treatment of BPH. The system’s real-time ultrasound imaging provides the surgeon with a multi-dimensional view of the prostate enabling personalized treatment planning tailored to each patient’s unique anatomy. The surgeon can specify which areas of the prostate to remove while preserving the anatomy that controls erectile function, ejaculatory function and continence. Once the treatment plan is mapped by the surgeon, the predictable robotic-assisted execution enables prostate tissue to be removed in a precise, targeted, and controlled fashion.
About PROCEPT BioRobotics Corporation
PROCEPT BioRobotics is a surgical robotics company focused on advancing patient care by developing transformative solutions in urology. PROCEPT BioRobotics develops, manufactures and sells the AquaBeam Robotic System, an advanced, image-guided, surgical robotic system for use in minimally invasive urologic surgery with an initial focus on treating benign prostatic hyperplasia, or BPH. BPH is the most common prostate disease and impacts approximately 40 million men in the United States. 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. The Company has developed a significant and growing body of clinical evidence, which includes nine clinical studies and over 150 peer-reviewed publications, supporting the benefits and clinical advantages of Aquablation therapy.
Forward Looking Statements
This release contains forward‐looking statements within the meaning of federal securities laws, including with respect to the Company’s projected financial performance for full year 2024, statements regarding the potential utilities, values, benefits and advantages of Aquablation® therapy performed using PROCEPT BioRobotics’ products, including AquaBeam® Robotic System, which involve risks and uncertainties that could cause the actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. You are cautioned not to place undue reliance on these forward-looking statements. Forward-looking statements are only predictions based on our current expectations, estimates, and assumptions, valid only as of the date they are made, and subject to risks and uncertainties, some of which we are not currently aware. Forward-looking statements may include statements regarding financial guidance, market opportunity and penetration, the Company’s possible or assumed future results of operations, including descriptions of the Company’s revenues, gross margin, profitability, operating expenses, installed base growth, commercial momentum, reimbursement coverage, overall business strategy, or information regarding the impact of other global events on the Company and its operations. Forward‐looking statements should not be read as a guarantee of future performance or results and may not necessarily be accurate indications of the times at, or by, which such performance or results will be achieved. These forward‐looking statements are based on the Company’s current expectations and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward‐looking statements as a result of these risks and uncertainties. These risks and uncertainties are described more fully in the section titled “Risk Factors” in the Company’s filings with the Securities and Exchange Commission (the “SEC”), including the Company’s annual report on Form 10-K filed with the SEC on February 28, 2024. PROCEPT BioRobotics does not undertake any obligation to update forward‐looking statements and expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward‐looking statements contained herein. These forward-looking statements should not be relied upon as representing PROCEPT BioRobotics’ views as of any date subsequent to the date of this press release.
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/.
VP, Investor Relations and Business Operations

Frequently Asked Questions

What is Aquablation therapy?

Aquablation therapy is an ultrasound-guided, robotic-assisted method for treating benign prostatic hyperplasia (BPH) using a heat-free waterjet.

When will Aquablation therapy's CPT code change?

The CPT code for Aquablation therapy will change from Category III to Category I on January 1, 2026.

What does the new CPT Category I code signify?

The new Category I code reflects the widespread adoption and proven effectiveness of Aquablation therapy for treating BPH.

How does Aquablation therapy preserve patient anatomy?

Surgeons can plan the treatment to target specific areas of the prostate while preserving critical anatomy, aiding in erectile and ejaculatory function.

What company developed Aquablation therapy?

Aquablation therapy was developed by PROCEPT BioRobotics, a company focused on innovative surgical solutions in urology.

Last updated: Jun 17, 2024