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Late Breaking Abstract Presented at the Japanese Urological Association Annual Meeting on Aquablation Therapy Outcomes for Men in Japan with Lower Urinary Tract Symptoms due to Benign Prostatic Hyperplasia

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PROCEPT BioRobotics presented a late-breaking post-market survey at the Japanese Urological Association Annual Meeting on positive Aquablation therapy outcomes for men in Japan with lower urinary tract symptoms due to benign prostatic hyperplasia. The data showcased the safety and effectiveness of Aquablation therapy in treating men with BPH, highlighting reproducible results and supporting a paradigm shift in the surgical treatment of the condition.

Key highlights from the data include treating 103 men with mean age and baseline IPSS of 71 ± 7 and 18 ± 9, respectively, with a mean prostate volume of 82 ml. The data showed significant improvements in IPSS and quality-of-life scores, with no reports of pad-use incontinence or serious device-related adverse events. The results demonstrate the exceptional safety and efficacy of Aquablation therapy in Japanese men with BPH.

Positive
  • The late-breaking presentation at the JUA Annual Meeting highlighted the safety and effectiveness of Aquablation therapy in treating men with BPH.

  • The data showed reproducible results and significant improvements in IPSS and quality-of-life scores for men in Japan with lower urinary tract symptoms due to BPH.

  • No reports of pad-use incontinence or serious device-related adverse events were observed, indicating the safety of Aquablation therapy in Japanese men.

Negative
  • None

Japanese post market survey supports safety and efficacy of Aquablation therapy

SAN JOSE, Calif., April 29, 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, today announced the presentation of a late breaking post-market survey at the Japanese Urological Association (JUA) Annual Meeting on positive Aquablation therapy outcomes for men in Japan with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH).

“The data presented at the JUA showcase the global reach of Aquablation therapy and its safety and effectiveness in treating men across geographic regions and demographics,” said Reza Zadno, CEO of PROCEPT BioRobotics. “The reproducible results observed in numerous real-world Aquablation therapy cases continue to support a paradigm shift in the surgical treatment of BPH.”

Data Highlights

  • 103 men were treated with a mean age and baseline international prostate symptom score (IPSS) of 71 ± 7 and 18 ± 9, respectively
  • Mean prostate volume was 82 ml (range 33-242 ml)
  • Proportion of patients who were on BPH medication, had prior BPH surgery or catheter use for retention were 58%, 1% and 26%, respectively
  • No reports of pad-use incontinence or serious device-related adverse events
  • Three-month average IPSS improved to 7 ± 5
  • Quality-of-life baseline score was 5 ± 1 and at three-month follow-up, improved to 2 ± 2

“It was an honor to deliver the late breaking presentation that treated only Japanese men with LUTS due to BPH,” said Dr. Nobuyuki Hinata, Professor and Chairman of Hiroshima University Hospital. “The results showed the contemporary Aquablation procedural safety in Japanese men is exceptional in a broad range of prostate sizes along with significant symptom reduction. This data align with the numerous global publications and real-world data that have eclipsed 50,000 procedures.”

For more information on Aquablation therapy, please visit www.procept-biorobotics.com or www.procept-biorobotics.jp.

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 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 expected to be filed with the SEC on or about 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/

Media Contact:
Lauren Cohen
Senior Director, Integrated Marketing Communications
l.cohen@procept-biorobotics.com

Investor Contact:
Matt Bacso
VP, Investor Relations and Business Operations
m.bacso@procept-biorobotics.com


FAQ

What is the focus of the late-breaking abstract presented at the JUA Annual Meeting?

The late-breaking abstract presented at the JUA Annual Meeting focused on Aquablation therapy outcomes for men in Japan with lower urinary tract symptoms due to benign prostatic hyperplasia.

How many men were treated in the post-market survey?

103 men were treated in the post-market survey.

What were the key findings regarding the mean age and baseline IPSS of the men treated?

The men treated had a mean age of 71 ± 7 and a baseline IPSS of 18 ± 9.

Were there any reports of pad-use incontinence or serious device-related adverse events?

No reports of pad-use incontinence or serious device-related adverse events were observed.

Where can more information on Aquablation therapy be found?

For more information on Aquablation therapy, please visit www.procept-biorobotics.com or www.procept-biorobotics.jp.

PROCEPT BioRobotics Corporation

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