PROCEPT BioRobotics Corporation, surgical robotics company, focuses on advancing patient care by developing transformative solutions in urology.
The company develops, manufactures, and sells the AquaBeam Robotic System and HYDROS Robotic System, which are advanced, image-guided, surgical robotic systems for use in minimally invasive urologic surgery, with an initial focus on treating benign prostatic hyperplasia, or BPH. Each of its robotic systems employs a single-use disposable handpiece to d...
PROCEPT BioRobotics Corporation, surgical robotics company, focuses on advancing patient care by developing transformative solutions in urology.
The company develops, manufactures, and sells the AquaBeam Robotic System and HYDROS Robotic System, which are advanced, image-guided, surgical robotic systems for use in minimally invasive urologic surgery, with an initial focus on treating benign prostatic hyperplasia, or BPH. Each of its robotic systems employs a single-use disposable handpiece to deliver its proprietary Aquablation therapy, which combines real-time, multi-dimensional imaging, personalized treatment planning, automated robotics, and heat-free waterjet ablation for targeted and rapid removal of prostate tissue. The company designed its robotic systems to enable consistent and reproducible BPH surgery outcomes. The company 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, and deliver resection independent of 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. As of December 31, 2024, the company had an install base of 647 AquaBeam Robotic Systems and HYDROS Robotic Systems globally, including 505 in the United States.
The company began developing its proprietary AquaBeam Robotic System in 2009 to address many of the shortcomings of alternative surgical interventions by delivering its Aquablation therapy, the first and only image-guided robotic therapy for the treatment of BPH.
The company has developed a significant and growing body of clinical data that demonstrates the efficacy, safety, and durability of Aquablation therapy, with resection that is independent of prostate size and shape and surgeon experience. The company’s robust body of clinical evidence includes nine clinical studies and over 150 peer-reviewed publications. The company’s WATER study is the only FDA pivotal study randomized against TURP. In this study, Aquablation therapy demonstrated superior safety and non-inferior efficacy compared to TURP across prostate sizes between 30 ml and 80 ml, and superior efficacy in a subset of patients with prostates larger than 50 ml. The company has established strong relationships with key opinion leaders, or KOLs, within the urology community, and collaborated with key urological societies in global markets. This support has been instrumental in facilitating broader acceptance and adoption of Aquablation therapy.
In the United States, the company primarily sells its products to hospitals, or end customers, and to a lesser extent, distribution partners, ambulatory surgery centers, and leasing companies. The end customers, in turn, bill various third-party payors, such as commercial payors and government agencies, for reimbursement for the procedures using its products. Effective in 2021, all local Medicare Administrative Contractors, or MACs, which represent 100% of eligible Medicare patients, issued final positive local coverage determinations to provide Medicare beneficiaries with access to Aquablation therapy in all 50 states, so long as such beneficiaries meet certain clinical criteria set forth in the local coverage determination.
The company primarily sells its products through its direct sales organization in the United States, which targets urologists across the United States, who represent the primary physician specialty managing the care of patients with BPH. The company targets approximately 2,700 hospitals that perform resective BPH procedures in the United States. The company estimates that approximately 50% of BPH patients who are on drug therapy, as well as 50% who have failed drug therapy, are under the care of a urologist, equating to approximately 3.9 million men. Outside the United States, the company sells its products using both its direct sales organization and, in certain regions, its network of distribution partners.
Growth Strategies
The key elements of the company’s growth strategy are to grow its install base of robotic systems by driving adoption of Aquablation therapy among urologists; increase system utilization by establishing Aquablation therapy as the surgical treatment of choice for BPH; continue to broaden private payor coverage; build upon its strong base of clinical evidence; invest in high-quality clinical research to support the use of Aquablation therapy for prostate cancer; invest in research and development to drive continuous improvements and innovation; drive increased awareness of Aquablation therapy beyond the urology community; and further penetrate and expand into existing and new international markets.
Solution
The company’s first-generation AquaBeam Robotic System, an advanced, image-guided, surgical robotic system for use in minimally invasive urologic surgery, received De Novo FDA approval in December 2017. In August 2024, the company received FDA 510(k) clearance of its next-generation platform – the HYDROS Robotic System. The company’s proprietary AquaBeam Robotic System and HYDROS Robotic System each deliver the company’s Aquablation therapy, the first and only image-guided robotic therapy for the treatment of BPH. In August 2023, the company received 510(k) clearance from the FDA to remove the contraindication from its labeling that restricted Aquablation therapy from treating BPH in patients that also have an active diagnosis of prostate cancer. The most common side effects observed for Aquablation therapy are mild and transient and may include mild pain or difficulty when urinating, discomfort in the pelvis, blood in the urine, inability to empty the bladder, or a frequent or urgent need to urinate, and bladder or urinary tract infection. During the company’s clinical studies, it documented a rate of incontinence between 0%-2%, ejaculatory dysfunction between 6.9%-24.6%, and a peri-operative transfusion rate between 0.9%-5.9%.
Robotic Systems
The company designs and markets two robotic systems: the next-generation HYDROS Robotic System where cleared, and the first-generation AquaBeam Robotic System. Both systems leverage a heat-free waterjet for automatic robotic execution, reducing the risk of complications associated with prolonged thermal injury. They also feature real-time image guidance that integrates intraoperative ultrasound imaging with cystoscopic visualization, offering a multidimensional view of the treatment area to enhance decision-making and enable real-time monitoring during procedures.
The robotic systems support personalized treatment planning through advanced software and ultrasound imaging, allowing surgeons to map the treatment contour to precisely target the resection area and optimize tissue removal based on each patient’s unique anatomy. With the introduction of the HYDROS Robotic System in August 2024, the company unveiled the FirstAssist AI feature. This innovation combines ultrasound imaging with advanced planning software to assist urologists in identifying key anatomical landmarks, enabling precise targeting of the resection area using the waterjet. By tailoring the tissue removal plan to individual anatomy, the FirstAssist AI feature aims to enhance procedural accuracy and outcomes.
Structurally, the HYDROS Robotic System fully integrates an advanced ultrasound system and a digital cystoscope, providing the ability to improve visualization and streamline the operating room setup process. Additionally, the HYDROS Handpiece comes pre-assembled with a single-use digital scope, eliminating the need for reprocessing the cystoscope between procedures.
These advanced features are designed to further deliver safe, effective, and durable outcomes for men suffering from lower urinary tract symptoms (LUTS) caused by BPH, regardless of prostate size and shape, and resection independent of surgeon experience.
Clinical Results and Studies
A significant body of clinical evidence supports the efficacy, safety, and durability of Aquablation therapy across prostate sizes and shapes, as well as surgeon experience. This robust body of evidence includes more than 150 peer-reviewed publications in premier journals, such as the Journal of Urology, European Urology, and BJU International, as well as nine clinical studies, including its three core studies: WATER, WATER II, and OPEN WATER.
Prostate Therapy
WATER: The WATER study was a double-blind, randomized, controlled study of Aquablation therapy against TURP in men with prostate sizes between 30 ml and 80 ml. This study is the only FDA pivotal trial for BPH randomized against TURP. The study was designed with 80% power to show superiority in safety and more than 80% power to show non-inferiority in efficacy. The results of the company’s WATER study served as the basis for FDA grant of its De Novo request and were first published in the Journal of Urology in 2018. The study has concluded with five-year data.
WATER II: The WATER II study was a prospective, multicenter study of Aquablation therapy in patients with prostate sizes between 80 ml and 150 ml. The study was designed with 80% power for safety and 99% power for efficacy against an objective performance criteria, or OPC, based upon TURP data, even though TURP procedures are typically performed in smaller prostates. The results of the WATER II study served as the basis for increased reimbursement and coverage and were first published in BJU International in 2019. The study has concluded with five-year data.
OPEN WATER: The OPEN WATER study was a prospective, multicenter, all-comer study conducted in a commercial setting spanning patients with prostate sizes between 20 ml and 150 ml. Due to the size of this study, it was sufficiently powered to statistical conclusions with the data. There was no OPC established for this study. The results of the OPEN WATER study were first published in Journal of Clinical Medicine in 2020. The study has concluded with one-year data.
Cancer Therapy
PRCT001: The PRCT001 study is a global, prospective, post-market, multi-center study of Aquablation therapy in patients with BPH and localized prostate cancer. The study is designed to assess safety in this population. The sample size of the study is 125 and is planned to be conducted in the United States, Hong Kong, Lebanon, Canada, and Portugal.
PRCT002: The PRCT002 study is an investigational device exemption, or IDE (G230155), prospective, post-market, multi-center study of Aquablation therapy in patients with localized prostate cancer. The study has completed enrollment across three centers in the United States.
WATER IV PCa: WATER IV PCa is a global multicenter, prospective, randomized clinical study designed to assess the safety and efficacy of Aquablation therapy compared to radical prostatectomy in men with Grade Group 1 to 3 localized prostate cancer. There is a co-primary endpoint based on morbidity evaluated at the six-month follow-up. A key secondary endpoint is to measure the rate of Grade Group progression in the Aquablation therapy arm, which will be evaluated at the twelve-month follow-up. The study is planned to enroll up to 280 patients at up to 50 centers and follow them for 10 years. The patients will be randomized on a 3:1 basis, with 210 patients receiving Aquablation therapy and 70 patients receiving radical prostatectomy. Longer-term follow-up focuses on both the reduction in treatment-related harm and oncologic events.
Sales and Marketing
Commercial Activities in the United States
The company designed its commercial strategy and built its direct sales team to target primarily urologists across the United States, who represent the primary physician specialty managing the care of patients with BPH. The company estimates that there are approximately 12,000 urologists who manage approximately 4.3 million BPH patients, consisting of 400,000 undergoing BPH surgery annually, 3.3 million who are on drug therapy, and 600,000 who have tried but failed drug therapy. The company is first focused on driving adoption of Aquablation therapy among urologists who perform hospital-based BPH resective surgery. The company targets the 2,700 hospitals where it estimates approximately 290,000 respective BPH surgeries of the 400,000 BPH surgeries are performed annually. Within each hospital, the company is focused on targeting urologists who perform medium-to-high volumes of resective procedures and converting their resective cases to Aquablation therapy.
The company’s direct sales organization actively engages with providers to drive awareness, adoption, and utilization of its Aquablation therapy. This team is supported by clinical specialists who are responsible for training and supporting surgeons, reimbursement specialists, who are responsible for customer and physician education on coding, coverage, and payment, and field support employees, who provide preventative maintenance and technical support for its customers.
In addition to the company’s direct sales efforts, it supports its sales organization with marketing and market development initiatives. The company plans to continue to expand and enhance its marketing capabilities to support its growing commercial organization and customer base. The company’s near-term marketing efforts center principally on increasing awareness and driving adoption of Aquablation therapy among urologists by continuing to publish clinical data in various industry and scientific journals, present its clinical data at various industry conferences, expand its network of KOLs, and sponsor peer-to-peer education programs and workshops.
Commercial Activities Outside of the United States
Outside the United States, the company utilizes both a direct sales organization and, in certain regions, a network of distribution partners. In the United Kingdom and Japan specifically, the company has increased the size of its direct sales force following recent reimbursement decisions specific to Aquablation therapy in those countries. In markets where the company’s coverage is limited, it collaborates with distribution partners to support market development and sales efforts. The company strategically selects partners with clinical and marketing expertise to help it enter new markets. The company’s focus is on partners who can assist with surgeon training and, when necessary, securing regulatory approvals.
Third-Party Reimbursement
In the United States, the primary end users of the company’s products are hospitals. These end users, in turn, bill various third-party payors, such as commercial payors and government agencies, for reimbursement for the procedures using its products. The company’s market access team includes professionals who are focused on all key aspects of reimbursement, which include securing appropriate coding, payment, and coverage policies for its products and procedures using its products. This team focuses both on payer engagement, as well as providing support to the providers.
Manufacturing and Supply
The company directly manufactures its robotic systems, the handpiece, and other accessories at its facility in San Jose, California. This includes supporting the supply chain distribution and logistics of the various components. Components, sub-assemblies, and services required to manufacture the company’s products are purchased from numerous global suppliers. Each AquaBeam Robotic System or HYDROS Robotic System is shipped to its customers with a third-party manufactured ultrasound system and probes. The company utilizes well-known third-party logistics providers located in the United States, United Kingdom, and the Netherlands to ship its products to its customers globally. The company relies on third-party suppliers, almost all of whom are single-source suppliers, to provide it with certain components, sub-assemblies, and materials for its products. The company’s suppliers manufacture the components they produce for it and test its components and devices to its specifications. The company has entered into manufacturing and supply agreements with several of its single-source suppliers pursuant to which they supply the components it needs. In addition, the company intends to maintain sufficient levels of inventory to enable it to continue its operations while it obtains another supplier in the event that one or more of its single-source suppliers were to encounter a delay in supply or end supply.
Intellectual Property
As of December 31, 2024, the company had rights to 60 issued U.S. patents, expiring between 2028 and 2042, 133 issued foreign patents, expiring between 2028 and 2041, 38 pending U.S. patent applications, six pending PCT applications, and 55 foreign patent applications.
As of December 31, 2024, the company’s rights to foreign issued patents included 21 granted Chinese patents, 30 granted Japanese patents, seven Brazilian patents, six Indian patents, and 17 granted European patents, of which 12 have been validated in Germany, 10 in Spain, 11 in France, 17 in the United Kingdom, six in Ireland, nine in Italy, one in Switzerland, and three European patents with unitary effect. As of December 31, 2024, the company’s rights to foreign patent applications included 18 pending European applications, 17 pending Chinese applications, 14 pending Japanese applications, two pending Brazilian applications, one pending Indian application, and three pending Hong Kong applications.
As of December 31, 2024, the company had 44 pending and registered trademark filings worldwide, some of which may provide trademark protection in multiple countries.
License Agreement with AquaBeam LLC
In 2008, the company assigned to AquaBeam LLC, or AquaBeam, certain provisional patent applications, or AquaBeam Patent Applications, which have since issued as patents, and any future patent applications that claim priority to the AquaBeam Patent Applications, or AquaBeam Patents.
In September 2019, the company entered into an amended and restated license agreement, or the AquaBeam License Agreement, with AquaBeam. Pursuant to the AquaBeam License Agreement, AquaBeam granted the company a worldwide, exclusive (even as to AquaBeam), sublicensable, royalty-free license under the AquaBeam Patents and to all other patent rights owned by AquaBeam, that claim certain technology related to delivering energy to tissues by directing a liquid fluid stream, or together with AquaBeam Patents, Licensed Patents, in the field of urology, or Field.
The AquaBeam License Agreement will remain in full force and effect on a country-by-country basis until the last to expire of the Licensed Patents and the PROCEPT Patents in such country. The expiration date of the last-to-expire of the Licensed Patents and PROCEPT Patents will not be earlier than 2037. The AquaBeam License Agreement may be terminated by either party in the event of uncured material breach by the other party that remains uncured for 90 days (or 30 days for payment-related breaches), or bankruptcy of the other party.
License Agreement with HydroCision
The company is party to a Confidential Exclusive Patent License and Covenant Not To Sue, or the HydroCision License Agreement, with HydroCision, Inc., or HydroCision. Pursuant to the HydroCision License Agreement, HydroCision granted the company a worldwide, exclusive, sublicensable, royalty-free license to certain patents related to fluid jet technology in the field of urology, or the Fluid Jet Technology Patents, and related know-how and documentation. HydroCision also granted the company a non-exclusive license to patents allowing it to make, sell, import, export, or otherwise dispose of products made using the Fluid Jet Technology Patents.
The HydroCision License Agreement will remain in full force and effect until the last to expire of the Fluid Jet Technology Patents. The expiration date of the last-to-expire of the Fluid Jet Technology Patents will not be earlier than 2039.
Research and Development Expenses (R&D)
The company’s R&D expenses increased to $62.3 million during the year ended December 31, 2024.
Government Regulation
The company’s products and its operations are subject to extensive regulation by the FDA and other federal and state authorities in the United States, as well as comparable authorities outside the United States. The company’s products are subject to regulation as medical devices under the Federal Food, Drug, and Cosmetic Act, or FDCA, as implemented and enforced by the FDA.
The company’s currently marketed robotic systems are Class II devices, which were initially granted marketing authorization pursuant to a de novo classification. The company has subsequently received FDA clearance of a 510(k) pre-market notification for modifications to its robotic systems, where it used the initially authorized device as the predicate device for its more recent 510(k) clearance.
The company’s HYDROS Robotic System is a Class II device that was cleared under the 510(k) premarket notification process. Under the 510(k) process, the manufacturer must submit to the FDA a premarket notification submission demonstrating that the proposed device is “substantially equivalent,” as defined in the FDCA, to a legally marketed predicate device.
In addition to FDA restrictions on marketing and promotion of drugs and devices, other federal and state laws restrict the company’s business practices. These laws include, without limitation, foreign, federal, and state anti-kickback and false claims laws, as well as transparency laws regarding payments or other items of value provided to healthcare providers.
By way of example, in the United States, the ACA was enacted in March 2010 and substantially changed the way healthcare is financed by both governmental and private insurers, and significantly impacts the company’s industry.
The company’s U.S. operations are subject to the FCPA. The company is required to comply with the FCPA, which generally prohibits covered entities and their employees, agents, and intermediaries from engaging in bribery or authorizing, promising, providing, or offering, directly or indirectly, anything of value to foreign officials for the purpose of obtaining or retaining business or other benefits. In addition, the FCPA imposes accounting standards and requirements on publicly traded U.S. corporations and their foreign affiliates, which require such companies to maintain complete and accurate books and records, and maintain a system of internal accounting controls. The company is also subject to similar anticorruption laws and regulations implementing the Organization for Economic Co-operation and Development’s Convention on Combating Bribery of Foreign Public Officials in International Business Transactions.
History
PROCEPT BioRobotics Corporation was incorporated in the state of California in 2007.
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