PROCEPT BioRobotics Revolutionizes BPH Treatment with First FDA-Approved Robotic System for Prostate Surgery

Benign Prostatic Hyperplasia (BPH) is a condition whose prevalence increases with age. In the United States, it affects approximately 40 million men. BPH is the leading cause for men to visit urologists. In China, prostatic hyperplasia is also a common condition in urology departments. BPH symptoms worsen over time, significantly impairing quality of life, and if left untreated, may lead to bladder, urinary tract, or kidney problems.

The primary treatment modalities for prostatic diseases include oral medication, local injection therapy, surgical intervention, and extracorporeal physical therapy. Prior to the availability of effective pharmacological agents, surgery was the mainstay of treatment and remained the optimal choice for patients with severe disease. Minimally invasive surgery, specifically transurethral resection of the prostate (TURP), has long been established as the gold standard for the surgical management of benign prostatic hyperplasia (BPH).

However, for PROCEPT BioRobotics Corporation, the “gold standard” is far from the pinnacle of minimally invasive surgery for benign prostatic hyperplasia (BPH). Founded in 2007, PROCEPT BioRobotics Corporation is a surgical robotics company dedicated to developing intelligent solutions to transform the field of urology, and it has a better approach to treating BPH.

The AquaBeam robotic system, developed through its research and development efforts, enables more targeted, controllable, rapid, and minimally traumatic prostatectomy procedures. This system is an advanced, image-guided surgical robotic platform,It is the first FDA-approved automated surgical robot for treating this common condition.In addition, PROCEPT has developed a complementary technology known as Aquablation therapy. This therapy is the first and currently only image-guided robotic therapy for the treatment of benign prostatic hyperplasia (BPH).

On July 2, 2021, urological surgical robotics company PROCEPT BioRobotics Corporation announced that it had secured $85 million in Series G financing. The round was led by Fidelity Management & Research Company, with participation from new investor T. Rowe Price Associates and existing investors CPMG, Perceptive Advisors, Viking Global Investors, and Duquesne Family Office. PROCEPT stated that the proceeds would be used to support the global commercial expansion of its AquaBeam Robotic System.

The prostate is a male-specific gonadal organ. Prostate diseases are highly prevalent among adult males and typically refer to prostatitis, benign prostatic hyperplasia (BPH), and prostate cancer. These conditions may present with symptoms such as urinary frequency, urgency, dysuria, and hematuria, and can be complicated by sexual dysfunction or even systemic diseases.

Prostate diseases are a category of urological disorders. According to survey data from the World Health Organization, more than half of men over the age of 50 are affected by prostate conditions. Among men aged 20 to 40, 20% suffer from prostatitis, and 16% have urogenital infections.

According to the intelligence provider GBI Research, the global market for prostate cancer treatments alone is projected to grow rapidly to $13.6 billion in 2021. A report released by the global market research firm GlobalData also points out that by 2023, the size of the prostate cancer treatment market across the nine major pharmaceutical markets (the United States, Japan, Brazil, Canada, and the five major European countries: the United Kingdom, France, Germany, Italy, and Spain) will triple, reaching $8.3 billion, with a compound annual growth rate (CAGR) of 12.4% during the forecast period (2013–2023).

Additional reports indicate that the global urology equipment market is projected to grow from $38 billion in 2021 to $46.4 billion in 2026, representing a compound annual growth rate (CAGR) of 4.1%. The growth of the urology equipment market is driven by numerous factors, including the rising incidence and prevalence of urological diseases, increasing preference for minimally invasive surgeries, the growing number of hospitals, and increased investment in endoscopic and laparoscopic facilities.

By product category, the urology equipment market is segmented into instruments, consumables, and accessories. The instruments segment accounted for the largest share of the urology equipment market in 2020. This segment includes dialysis equipment, endoscopes, laser and lithotripsy devices, robotic systems, endoscopic and imaging systems, insufflators, endoscopic fluid management systems, and urodynamic systems. Among these, surgical robots have broad development prospects and hold significant potential for application across various medical scenarios.

Benign Prostatic Hyperplasia (BPH) is a non-cancerous enlargement of the prostate that can lead to urethral irritation or obstruction, as well as urinary tract obstruction. Traditional minimally invasive surgeries for BPH utilize thermal energy (high-thermal-energy technologies) to remove or reduce prostate tissue, thereby improving symptoms and urine flow. Although these procedures can significantly alleviate symptoms and improve urinary flow rates, they are associated with significant side effects, including bleeding, diarrhea, incontinence, and sexual dysfunction. Other interventional treatment options also involve a trade-off between improving patient symptoms and the risk of complications.

People need a more minimally invasive solution that can continuously and significantly improve quality of life while reducing the risk of adverse reactions.

PROCEPT’s urologic surgical robot was developed to meet this need.

PROCEPT’s core product is the AquaBeam Robotic System, which has received FDA clearance in the United States. AquaBeam is the world’s first technology to combine image guidance, robotic technology, and high-velocity saline for the targeted, heat-free removal of prostate tissue. Early studies have demonstrated its high clinical efficacy and robust safety profile. The system’s ability to conform to the surgical resection plane enables the preservation of key anatomical landmarks, thereby helping to maintain normal sexual function. Its rapid resection time and potential to preserve sexual function constitute its primary advantages, holding significant importance for men seeking to retain sexual function.

PROCEPT has also developed a complementary technology—Aquablation therapy—which consists of three main components: the Conformal Treatment Planning System (CPU), the console, and the robotic handpiece, and is operated using the AquaBeam Robotic System.

Following anesthesia, and under the guidance of real-time transrectal ultrasound imaging, the physician delineates the surgical target zone using a conformal planning treatment system (CPU). Subsequently, hyperplastic prostate tissue is resected via a high-speed saline jet in the form of a waterjet. The entire resection procedure takes less than 10 minutes and offers advantages such as real-time multi-dimensional imaging, high surgical precision, and absence of thermal injury.

In the global, randomized, double-blind WATER (Waterjet Ablation therapy for Endoscopic Resection of Prostate) study, researchers compared Aquablation therapy with the surgical gold standard, transurethral resection of the prostate (TURP). Data initially published in 2017 demonstrated that Aquablation therapy exhibited robust efficacy, offering a superior safety profile and reduced postoperative side effects compared with TURP. Follow-up data at one year further confirmed the therapy’s sustained benefits, including lower rates of sexual side effects, durability of symptom relief, improved peak urinary flow rates, and low retreatment rates. Furthermore, the Centers for Medicare & Medicaid Services (CMS) determined that Aquablation provides “substantial clinical improvement” over both TURP and simple prostatectomy for prostates larger than 50 mL.

On May 3, 2019, the American Urological Association (AUA) announced that it had revised its surgical practice guidelines to include Aquablation therapy as a standard-of-care treatment for male lower urinary tract symptoms (LUTS) caused by benign prostatic hyperplasia (BPH), or prostate enlargement. Prior to this, the Canadian Urological Association had already incorporated Aquablation therapy into its guidelines for male urinary symptoms.

In 2019, PROCEPT BioRobotics Corporation also received approval for Transitional Pass-Through (TPT) payment from the Centers for Medicare & Medicaid Services (CMS), expanding the availability of Aquablation therapy to outpatient settings. TPT payments provide incremental reimbursement for devices used in outpatient environments. The CMS approval report stated: Data indicate that Aquablation therapy offers advantages over other technologies, particularly in reducing overall operative time and complications, especially in cases of larger benign prostatic hyperplasia (BPH); there is a lower proportion of persistent adverse events (incontinence, sexual dysfunction) within three months post-procedure; furthermore, clinical study results from WATER II in patients with large prostates demonstrated that Aquablation therapy yields better outcomes compared to open prostatectomy, namely shorter operative times, reduced hospital stays, and lower rates of severe bleeding and blood transfusions.

On July 2, 2021, urological surgical robotics company PROCEPT BioRobotics Corporation announced that it had secured $85 million in Series G financing. The round was led by Fidelity Management & Research Company, with participation from new investor T. Rowe Price Associates and existing investors CPMG, Perceptive Advisors, Viking Global Investors, and Duquesne Family Office.

Prior to this round of financing, PROCEPT had completed more than seven funding rounds, including a $77 million Series F round on August 14, 2020; a $118 million Series E round on February 20, 2018, which benefited from the FDA’s clearance in December 2017 of AquaBeam, the first robotic surgical system for prostate diseases developed by the company; and a $42 million Series D round on July 7, 2015. According to Crunchbase data, after more than eight rounds of financing, PROCEPT’s total funding amount reached $368.3 million.

PROCEPT BioRobotics Corporation stated that it aims to establish the AquaBeam surgical robot as the paradigmatic solution for treating benign prostatic hyperplasia, replacing traditional therapies and accelerating its global business expansion following its Series G financing (this round).

Previously, PROCEPT BioRobotics Corporation has been striving to expand commercial insurance and Medicare coverage for its AquaBeam surgical robot.

On September 24, 2020, National Government Services (NGS) became the first Medicare Administrative Contractor (MAC) to issue final Medicare coverage determinations for water-jet therapy and surgical robots.

On November 16, 2020, PROCEPT BioRobotics Corporation announced that its Aquablation therapy and surgical robot would be covered by Medicare nationwide in the United States starting December 27, 2020.Medicare Administrative Contractors (“MACs”)—First Coast Service Options, Inc. (First Coast), Noridian Healthcare Solutions, LLC (Noridian), Novitas Solutions, Inc. (Novitas), GBA, LLC (Palmetto), and Wisconsin Physicians Service Insurance Corporation (WPS)—jointly issued a Local Coverage Determination (LCD) policy for hydromechanical therapy, which became effective on December 27, 2020. Additionally, these five MACs joined National Government Services, Inc. (NGS) and CGS Administrators, LLC (CGS), whose coverage policies for hydromechanical therapy took effect in November 2020.

On April 15, 2021, Blue Cross Blue Shield of Massachusetts and EmblemHealth announced insurance coverage for the AquaBeam Robotic System and hydrodynamic therapy. This expansion increased the availability of this therapy to over 100 million people in the United States.

According to incomplete statistics from the Arterial Orange database, a total of 74 financing events (excluding IPOs, private placements, etc.) occurred globally in the medical device sector in June 2021, with the disclosed total financing amount exceeding $2.463 billion (approximately RMB 15.93 billion). Among these, the medical robotics sector saw 4 financing events, with the disclosed total transaction value reaching $910 million, a month-on-month increase of 938%, making it the most capital-attractive sub-sector within medical devices in June. This significant surge was driven by two high-value financing rounds exceeding $100 million each during the month; notably, surgical robotics company CMR Surgical announced that it had secured $600 million in Series D financing.

In April 2021, there were a total of nine financing events in the medical robotics sector, with the total funding amount reaching $467 million, representing a 641% increase compared to March.

With the advancement of digital healthcare, the global medical robotics industry has experienced rapid growth and a swift expansion in market size. According to data from the International Federation of Robotics (IFR), the global medical robotics market was valued at $13.6 billion in 2018 and is projected to reach $20.7 billion by 2021, representing a compound annual growth rate (CAGR) of 15%. Among these, surgical robots constitute the largest segment; PwC forecasts that the surgical robotics market will reach $6.44 billion in 2021, accounting for 31% of the total. The Asia-Pacific region will serve as the primary driver of growth in the medical robotics sector.