PROCEPT BioRobotics Corporation (PRCT): PESTLE Analysis [Nov-2025 Updated]

You're looking at a high-growth medical device story with PROCEPT BioRobotics Corporation (PRCT), and the numbers for 2025 tell a clear tale: massive opportunity meets near-term execution risk. The company is set to hit approximately $325.5 million in revenue, a strong 45% jump, defintely driven by the new Category I CPT code and the next-gen HYDROS Robotic System. But don't overlook the reality check: they are still projecting an Adjusted EBITDA loss (Earnings Before Interest, Taxes, Depreciation, and Amortization, a measure of core operating profitability) of around ($35.0) million, plus they face a $2.0 million tariff headwind from US-China trade tensions. It's a race between technological dominance in a 40-million-man market and the cost of scaling.

Political: Geopolitical Friction and Regulatory Tailwinds

The political landscape presents a mixed bag of friction and regulatory support. On one hand, US-China trade tensions are a real cost driver, creating a tariff-related gross margin headwind of approximately $2.0 million in the second half of 2025. That directly impacts the bottom line. Still, the broader government focus on cost-effective, minimally invasive procedures strongly favors robotic surgery adoption like theirs.

International expansion, which accounts for a projected $36 million in 2025 revenue, remains complicated. You have to navigate diverse and complex foreign regulatory approval processes. Political stability in those key international markets is a direct factor in realizing that revenue target. The US government's preference for efficiency is a clear win.

Economic: High Growth, High Burn Rate

The core numbers are impressive, but they hide a key vulnerability. Full year 2025 revenue guidance is approximately $325.5 million, representing a strong 45% growth-that's a clear sign of product-market fit. Plus, the high gross margin of approximately 64.5%, driven by better operational efficiencies, shows the unit economics are powerful. Here's the quick math: a 64.5% margin means for every dollar of revenue, 64.5 cents cover operating costs and profit.

However, the company is operating at a loss, with a projected full year 2025 Adjusted EBITDA loss of approximately ($35.0) million. Also, rising interest rates increase the cost of capital for hospital customers, potentially slowing down system purchases. The high margin is great, but cash burn is still the limit.

Sociological: A Massive, Eager Market

This is where PRCT's story shines. The target market is huge and aging: Benign Prostatic Hyperplasia (BPH) affects over 40 million men in the US alone. This creates a massive, inelastic demand for better solutions. Strong clinical data from the WATER III study shows Aquablation therapy offers significantly lower rates of ejaculatory dysfunction, which directly addresses a major patient quality-of-life concern.

Increased patient and physician demand for quality-of-life preservation in urologic procedures is accelerating adoption. The new Category I CPT code, a major win, will likely broaden patient access and accelerate adoption by making reimbursement simpler and more predictable. Patients want better outcomes, and the data supports this procedure.

Technological: Dominance and Competition

PRCT maintains a technological lead with the rollout of the next-generation HYDROS Robotic System, which features FirstAssist AI treatment planning. This is a crucial moat. The U.S. installed base grew to 595 systems as of June 30, 2025, which drives high-margin, recurring handpiece revenue-a classic razor-and-blade model. The FDA Breakthrough Device Designation for Aquablation in prostate cancer expands the technology's addressable market beyond BPH, significantly increasing the long-term opportunity.

What this estimate hides is the intense competition from established surgical robotics companies like Intuitive Surgical. While PRCT is dominant in its niche, the broader surgical robotics field is highly competitive. Continuous innovation is non-negotiable.

Legal: Reimbursement Solidification

The legal and regulatory wins are perhaps the most critical near-term catalysts. The assignment of a Category I CPT code (Current Procedural Terminology, a medical code used to report procedures), effective January 1, 2026, solidifies reimbursement and removes a major hurdle for widespread hospital adoption. Medicare hospital facility reimbursement for Aquablation also saw a 5.6% increase, further easing hospital adoption economics.

The FDA approval to initiate the pivotal randomized clinical study WATER IV PCa for prostate cancer is a key step toward market expansion. Still, the need for new 510(k) or PMA clearance for future product modifications presents a continuous regulatory hurdle. You have to keep feeding the regulatory beast.

Environmental: Waste and Efficiency

Environmental factors are becoming a non-financial risk that impacts brand and operations. The company's move to a substantially larger LEED certified facility in 2023 demonstrates a focus on energy efficiency. They also have a commitment to ESG (Environmental, Social, and Governance), including e-waste recycling and waste segregation at their facilities.

However, the increased use of single-use disposable components (handpieces/scopes) creates a growing medical waste challenge for hospitals, which could become a friction point in purchasing decisions. PRCT is encouraging suppliers to adopt similar environmental policies to manage supply chain impact, but the disposable component issue is a structural challenge for the business model.

PROCEPT BioRobotics Corporation (PRCT) - PESTLE Analysis: Political factors

US-China trade tensions create a tariff-related gross margin headwind of approximately $\mathbf{\$2.0}$ million in H2 2025.

You need to be a realist about global trade friction, especially when your supply chain touches China. For PROCEPT BioRobotics Corporation, the ongoing US-China trade tensions are not just abstract politics; they translate directly into a cost-of-goods-sold (COGS) headwind. This is primarily due to tariffs on your ultrasound system components sourced from China.

The company has actively worked to mitigate this exposure, but the impact is still material. Based on the most recent guidance, PROCEPT BioRobotics expects a gross margin headwind of approximately $\mathbf{\$2.0}$ million in the fourth quarter of 2025 alone, which is a direct tariff-related cost. This figure is based on a Chinese tariff rate that had already declined to approximately 55% from a previous high of 145%. Here's the quick math: managing a $\mathbf{\$2.0}$ million tariff hit requires a clear strategy to offset it through operational efficiencies or price adjustments.

The tariff landscape remains highly fluid, and any further escalation or new Section 232 national security investigations-which the U.S. has initiated into imports of robotics and medical devices-could trigger additional costs. You can't ignore this risk. It's a real, near-term drag on your profitability targets.

Government focus on cost-effective, minimally invasive procedures favors robotic surgery adoption.

The political and regulatory environment in the U.S. strongly favors technologies that reduce healthcare costs and improve patient outcomes, and that's a massive tailwind for robotic surgery. The push is toward minimally invasive procedures because they mean shorter hospital stays, less pain, and lower infection rates.

A key example is the U.S. government's Advanced Research Projects Agency for Health (ARPA-H) and its Autonomous Interventions and Robotics (AIR) program. This program is explicitly focused on developing autonomous robotic systems to increase access to life-saving surgeries and transform invasive procedures into minimally invasive ones. Plus, the Centers for Medicare & Medicaid Services (CMS) finalized the Transitional Coverage for Emerging Technologies (TCET) pathway in 2024. While not specific to robotics, TCET offers an accelerated coverage on-ramp for certain FDA Breakthrough devices, which can help speed up the adoption of new robotic systems and adjacent technologies like AI modules. This is a defintely a policy environment that encourages your core business model.

International expansion requires navigating diverse and complex foreign regulatory approval processes.

While U.S. growth is strong, international markets are crucial for your long-term vision. But, every new country is a new political and regulatory maze. International revenue was $\mathbf{\$9.4}$ million in the third quarter of 2025, representing a $\mathbf{53\%}$ increase year-over-year. This growth, driven by strong sales momentum in markets like the United Kingdom, Japan, and Korea, is great, but it requires continuous, localized regulatory effort.

The regulatory hurdles in foreign markets are a known factor that can slow expansion. You must secure country-specific approvals, which are often complex and time-consuming, before you can sell your AquaBeam and HYDROS Robotic Systems. This process is a political risk because a change in government, a shift in national healthcare priorities, or a sudden policy change in a key market can halt your sales pipeline for months. You need deep, local regulatory expertise in every market you enter.

Political stability in key international markets directly impacts the projected $\mathbf{\$36}$ million in 2025 international revenue.

Your full-year 2025 international revenue is projected to be approximately $\mathbf{\$36}$ million, a $\mathbf{50\%}$ annual growth rate. This target is highly reliant on the political and economic stability of your key international markets. If political instability were to disrupt healthcare spending or import policies in a country like Japan or the UK-where you are seeing strong sales momentum-that $\mathbf{\$36}$ million target would be at risk.

Political risk can manifest in several ways:

• Currency Fluctuations: Political uncertainty can lead to foreign exchange losses, which the company has previously noted as an offset to interest and other income.
• Government Procurement Delays: Changes in government can freeze or significantly delay hospital capital expenditure approvals for expensive robotic systems.
• Trade Policy Shifts: New administrations can renegotiate trade agreements or impose new non-tariff barriers, creating unexpected costs.

This is why you must monitor political risk as closely as you monitor your sales funnel. The $\mathbf{\$36}$ million is a great target, but it's only as solid as the governments in those markets.

Next Step: Finance: Draft a contingency plan by the end of the quarter detailing how a $\mathbf{15\%}$ tariff increase would be absorbed without impacting the full-year $\mathbf{64.5\%}$ gross margin target.

PROCEPT BioRobotics Corporation (PRCT) - PESTLE Analysis: Economic factors

You're looking at PROCEPT BioRobotics Corporation's phenomenal growth numbers, and honestly, they look great, but the economic backdrop for their primary customer-the US hospital system-is still a tough one. The company's financial strength is currently driven by market adoption, not profitability, and that makes their capital sales sensitive to the broader economy.

The key takeaway is this: PROCEPT BioRobotics is a high-growth, high-margin story, projecting 45% revenue growth in 2025, but they are still burning cash, and the economic squeeze on hospitals' capital budgets presents a near-term risk to their system sales volume.

Full year 2025 revenue guidance is approximately $325.5 million, representing a strong 45% growth.

The company is projecting a massive top-line expansion for the full 2025 fiscal year. Management reiterated revenue guidance of approximately $325.5 million, which translates to a robust 45% year-over-year growth. This growth is largely fueled by the continued expansion of their U.S. installed base, which reached 653 systems as of September 30, 2025, and the corresponding increase in high-margin handpiece and consumable revenue.

Here's the quick math on their revenue mix, which shows the shift from capital sales to recurring revenue, a good sign defintely:

• Q3 2025 Total Revenue: $83.3 million
• Q3 2025 U.S. Handpiece and Consumables Revenue: $44.4 million (up 50% year-over-year)
• Q3 2025 U.S. System and Rental Revenue: $24.7 million (up 26% year-over-year)

Company is operating at a loss, with a projected full year 2025 Adjusted EBITDA loss of approximately ($35.0) million.

Despite the strong revenue growth, PROCEPT BioRobotics is still in a heavy investment phase, meaning they are not yet profitable. They project a full year 2025 Adjusted EBITDA (Earnings Before Interest, Taxes, Depreciation, and Amortization-a measure of operational performance) loss of approximately ($35.0) million. This loss is expected because the company is significantly increasing its operating expenses, projected to be around $302.0 million for the full year 2025, to expand its commercial organization and R&D efforts.

This is a classic growth-stock trade-off: you accept short-term losses for long-term market capture. The company's cash and equivalents totaled $297.3 million as of September 30, 2025, so they have a solid cushion to fund this loss and execute their growth strategy.

High gross margin of approximately 64.5%, driven by improved operational efficiencies and system pricing.

The underlying profitability of the product itself is excellent. The company expects its full year 2025 gross margin to be approximately 64.5%, which is a high figure for a medical device manufacturer. This margin strength comes from improved manufacturing efficiencies and higher average selling prices on their AquaBeam and HYDROS robotic systems. However, there is a small headwind to watch: the company has noted a potential gross margin headwind of approximately $2.0 million in the fourth quarter due to tariff-related costs.

Rising interest rates increase the cost of capital for hospital customers, potentially slowing system purchases.

This is the biggest external economic risk. The Federal Reserve's policy rate, even after cuts, remains elevated, with the federal funds rate in a target range of 3.75%-4.00% as of October 2025, and the Bank prime loan rate around 7.00%. This directly increases the cost of capital for hospitals, which often finance large capital equipment like the PROCEPT BioRobotics system through debt or leases.

The impact is real and measurable:

Hospitals are already in a tenuous financial situation due to persistent high non-labor costs (supplies, drugs) and Medicare reimbursement lagging behind inflation, covering only about 83 cents for every dollar spent between 2022 and 2024. When capital is this expensive, they scrutinize every large purchase. PROCEPT BioRobotics will need to offer flexible financing or procurement options to navigate this cautious spending environment.

PROCEPT BioRobotics Corporation (PRCT) - PESTLE Analysis: Social factors

Sociological

The core social factor driving PROCEPT BioRobotics Corporation's growth is the massive, aging demographic pool suffering from Benign Prostatic Hyperplasia (BPH). This condition, which is the most common prostate disease, impacts approximately 40 million men in the United States alone. This large and growing patient population translates directly into a robust and expanding market for effective treatment options.

The global BPH treatment market, which Aquablation therapy addresses, is projected to reach a value of USD 13.18 billion in 2025. North America holds a significant share of this market, demonstrating a strong regional opportunity for the company. The increasing prevalence of BPH symptoms, coupled with greater patient awareness, is a major market accelerator.

Increased Patient and Physician Demand for Quality-of-Life Preservation

A critical trend in urologic care is the heightened focus on patient-reported outcomes (PROs), specifically the preservation of quality of life, sexual function, and continence. Patients are increasingly seeking minimally invasive surgical procedures (MIS) that offer durable symptom relief with fewer side effects compared to traditional methods like Transurethral Resection of the Prostate (TURP) or laser procedures. This demand for a better trade-off between efficacy and side effects is where Aquablation therapy excels.

The market for minimally invasive surgical therapies is growing rapidly, reflecting this strong patient preference for faster recovery and reduced complications. Aquablation therapy is positioned as the only treatment that delivers durable symptom relief while maintaining a low risk of sexual function or continence side effects, which is a powerful differentiator in the modern healthcare landscape.

Strong Clinical Data (WATER III) Shows Superior Quality-of-Life Outcomes

The clinical evidence from the independent, investigator-initiated WATER III trial, with results announced in March 2025, provides a compelling social and clinical advantage for Aquablation therapy. The study compared Aquablation therapy to laser enucleation in treating large prostates (80-180 mL) and demonstrated a significant preservation of sexual function and continence.

Here's the quick math on the quality-of-life benefit:

The ability to offer effective symptom relief with a substantially lower risk of ejaculatory dysfunction-a major concern for men-is a powerful social driver for patient and physician adoption. This preservation of antegrade ejaculation was preserved for 99% of men in a separate 4-year outcomes study, solidifying the therapy's social appeal.

Category I CPT Code Accelerates Adoption

The assignment of a new Category I CPT code (52XX1) for Aquablation therapy, effective January 1, 2026, is a major social and economic catalyst. This transition from a Category III code signifies a formal recognition of the treatment's clinical value and widespread use by the medical community and payers, which will broaden patient access.

The new code will replace the Category III code (0421T) and is expected to further support surgeon adoption. The 2026 Medicare Proposed Physician Fee Schedule (PFS), released in July 2025, assigned a proposed national average payment of approximately $540 for the new code, which is slightly higher than the approximately $529 proposed for the traditional TURP procedure. This favorable reimbursement structure removes a potential financial barrier, making it easier for hospitals and ambulatory surgery centers (ASCs) to offer the procedure, defintely increasing its availability to the target patient population.

• Category I CPT code (52XX1) takes effect January 1, 2026.
• Proposed 2026 Medicare payment is approximately $540.
• This payment is higher than TURP's proposed $529.

PROCEPT BioRobotics Corporation (PRCT) - PESTLE Analysis: Technological factors

Rollout of the next-generation HYDROS Robotic System featuring FirstAssist AI treatment planning

The core of PROCEPT BioRobotics Corporation's technological moat is the next-generation HYDROS Robotic System, which received FDA 510(k) clearance in August 2024. This system is a significant upgrade, designed to improve efficiency and consistency for Aquablation therapy (a procedure using a heat-free water jet to remove prostate tissue). It's a smart move: you have to keep innovating to stay ahead, and AI is defintely the way to do it.

The key innovation is FirstAssist AI treatment planning, which is built from a library of over 50,000 real-world Aquablation procedures. This artificial intelligence software uses advanced image recognition on ultrasound to accurately identify critical anatomy and suggest an optimal, personalized treatment plan for the surgeon. This capability helps new surgeons learn the procedure faster and with greater precision, which is critical for mass-market adoption.

U.S. installed base grew to 653 systems as of September 30, 2025, driving recurring handpiece revenue

The company's technology strategy is creating a strong recurring revenue stream, which is the gold standard for medical device companies. The U.S. installed base of robotic systems grew significantly throughout 2025, reaching 595 systems as of June 30, 2025, and climbing further to 653 systems as of September 30, 2025. This growing base is the engine for the high-margin consumables business.

Here's the quick math on the recurring revenue: U.S. handpiece and consumable revenue for the third quarter of 2025 was $44.4 million, representing a 50% increase compared to the prior year period. This steady, procedural revenue stream provides financial stability and predictability, cushioning the business against the lumpiness of system sales, which were $24.7 million in U.S. system and rental revenue for Q3 2025.

FDA Breakthrough Device Designation for Aquablation in prostate cancer expands the technology's addressable market

The most significant near-term opportunity is the expansion of the Aquablation technology beyond benign prostatic hyperplasia (BPH). The FDA granted a Breakthrough Device Designation for Aquablation therapy in prostate cancer treatment in 2024. This designation expedites the review process for novel therapies that can significantly improve patient outcomes for life-threatening conditions.

The company has initiated the WATER IV PCa pivotal trial to compare Aquablation therapy against radical prostatectomy (the current standard of care) in men with localized prostate cancer. Analysts estimate that a successful outcome in this trial could unlock a new market opportunity valued at $500 million. This is a massive potential shift, positioning Aquablation as a first-line treatment for a new patient population, especially given its potential to reduce treatment-related harm like erectile dysfunction and incontinence compared to traditional surgery.

Intense competition from established surgical robotics companies like Intuitive Surgical

While PROCEPT BioRobotics dominates its niche in urology, the broader surgical robotics landscape is intensely competitive, dominated by well-capitalized giants. This competitive pressure forces continuous, expensive R&D investment.

The primary competitor is Intuitive Surgical, which holds a massive market lead. For perspective, Intuitive Surgical reported Q2 2025 revenue of $2.44 billion, a 21% year-over-year increase, driven by its da Vinci systems. Their global installed base is over 10,488 systems, and they hold nearly 60% of the global market share. Other major players like Medtronic, with its Hugo robot, are also aggressively expanding, particularly in international markets.

PROCEPT BioRobotics' strategy is to avoid direct competition by focusing on its specialized application. They are the only company offering an AI-powered, heat-free waterjet for BPH, but the risk remains that larger rivals could eventually develop competitive, procedure-specific robotic platforms or that urologists may prefer a single, multi-procedural platform like the da Vinci system for capital efficiency. That's the long-term strategic tension.

• Intuitive Surgical's Q2 2025 revenue: $2.44 billion.
• Intuitive Surgical's global installed base: over 10,488 systems.
• Intuitive Surgical's market share: nearly 60% globally.

PROCEPT BioRobotics Corporation (PRCT) - PESTLE Analysis: Legal factors

You're looking for a clear map of the regulatory landscape for PROCEPT BioRobotics Corporation, and honestly, the legal and reimbursement environment is currently a major tailwind, but it still holds the usual MedTech risks. The biggest near-term win is the shift to a permanent reimbursement code, which de-risks adoption for hospitals and physicians. Still, the company must continually navigate the FDA's stringent clearance process to keep their technology competitive.

Assignment of a Category I CPT code for Aquablation therapy, effective January 1, 2026, solidifies reimbursement.

The transition of Aquablation therapy from a temporary Category III Current Procedural Terminology (CPT) code to a permanent Category I CPT code (52XX1) is a critical legal and commercial milestone. This move, effective January 1, 2026, signals mainstream clinical acceptance and established efficacy for treating benign prostatic hyperplasia (BPH). It's a huge step because it removes a key financial disincentive for physicians.

The Centers for Medicare & Medicaid Services (CMS) proposed payment rates for 2026 show that Aquablation therapy will be reimbursed at a comparable, even slightly higher, rate than the traditional Transureurethral Resection of Prostate (TURP) procedure. The Final Rule is expected in November 2025, providing defintely solid visibility for 2026 planning.

Medicare hospital facility reimbursement for Aquablation saw a 5.6% increase, easing hospital adoption.

Beyond the physician fee, the hospital facility payment-which covers the capital equipment, disposables, and staff time-also saw a favorable update. For 2026, the Aquablation procedure is set to maintain its Ambulatory Payment Classification (APC) Level 6 status. This stability is good, but the rate itself is what matters for hospital economics.

The proposed Outpatient Prospective Payment System (OPPS) rule for 2026 indicates the facility payment rate is expected to increase by 5.6% year-over-year. Here's the quick math on that increase:

• Previous Facility Payment (Approx.): $9,247
• Proposed Facility Payment (Approx.): $9,765
• Increase: 5.6%

A higher facility payment eases the financial burden on hospitals, making it easier for them to justify the capital outlay for the AquaBeam or HYDROS Robotic Systems. This directly translates to faster system adoption for PROCEPT BioRobotics Corporation.

FDA approval to initiate the pivotal randomized clinical study WATER IV PCa for prostate cancer.

The U.S. Food and Drug Administration (FDA) approval of the Investigational Device Exemption (IDE) to initiate the pivotal randomized clinical study, WATER IV PCa, is a huge legal and clinical opportunity. This trial is designed to assess the safety and efficacy of Aquablation therapy for a new indication: localized prostate cancer (PCa) in men with Grade Group 1 to 3.

The company also secured a Breakthrough Device Designation for this indication, which can expedite the FDA's review process down the line. If successful, this trial opens up a massive new market, but it's a long road. The study is structured with a significant commitment:

• Enrollment Target: Up to 280 patients.
• Clinical Sites: Up to 50 global centers.
• Follow-up Period: 10 years.

This is a long-term risk-reward play. The 10-year follow-up means the commercial benefit for this indication is far out, but the study initiation itself is a positive signal to the market about the technology's potential beyond BPH.

The need for new 510(k) or PMA clearance for future product modifications presents a continuous regulatory hurdle.

Like any medical device company, PROCEPT BioRobotics Corporation operates under the constant regulatory pressure of the FDA. Any significant modification to a currently marketed device, or the introduction of a new one, requires a new 510(k) clearance or, for higher-risk devices, a Pre-Market Approval (PMA). This is a continuous operational and financial hurdle.

A recent example is the FDA 510(k) clearance of the next-generation HYDROS Robotic System in August 2024. This system, which includes new features like FirstAssist AI™ treatment planning, required a new clearance to be marketed. This process is expensive, time-consuming, and can delay product launches if the FDA requests additional data. The risk here is that a competitor could launch a new feature faster if PROCEPT BioRobotics Corporation faces unexpected regulatory delays on their next innovation cycle.

PROCEPT BioRobotics Corporation (PRCT) - PESTLE Analysis: Environmental factors

You need to be a trend-aware realist, so let's cut straight to the environmental factors. While PROCEPT BioRobotics Corporation (PRCT) shows clear intent on the operational side, the core business model-which relies on single-use components-creates a significant, growing downstream waste challenge for its hospital customers. This tension defines the environmental risk profile for 2025.

Commitment to ESG, including e-waste recycling and waste segregation at its facilities

The company maintains a formal commitment to Environmental, Social, and Governance (ESG) principles, focusing on internal operational efficiency and waste management. This policy includes waste segregation, reducing scrap, and lowering energy use.

On the manufacturing and R&D side, they actively manage electronic waste (e-waste). End-of-life electronic prototypes and lab equipment are processed by a third-party partner, which provides a Certificate of Destruction, ensuring proper disposal of hazardous materials.

Packaging waste is also a focus. In the first three months following the move to the new facility, the company recycled approximately 10 tons of cardboard packaging material. Plus, they estimate that roughly 25% of crates used for product returns are inspected and reused, cutting down on new material consumption.

The move to a substantially larger LEED certified facility in 2023 demonstrates a focus on energy efficiency

The company's relocation in September 2023 to its new headquarters in San Jose, California, was a clear move toward greater energy efficiency and scale. The new facility is substantially larger, estimated to be roughly four times the size of the previous 40,000 square-foot Redwood City location, putting the new space at approximately 160,000 square feet.

While the final certification status is not yet public, the company has been tracking the requirements to facilitate the building's future achievement of a Leadership in Energy and Environmental Design (LEED) certification. This focus on a high-efficiency building standard is a material step in managing the carbon footprint associated with a rapidly expanding manufacturing and R&D footprint.

Here's the quick math on the facility scale:

Increased use of single-use disposable components creates a growing medical waste challenge for hospitals

This is the primary environmental risk vector for the business model. The Aquablation therapy is delivered via a system that requires a single-use disposable handpiece for each procedure. The next-generation HYDROS Robotic System, which is being rolled out in 2025, doubles down on this model by including a single-use digital scope integrated into the handpiece.

The strategic benefit for hospitals is eliminating the need for complex, costly, and infection-risk-prone reprocessing of reusable scopes. But, this convenience directly translates into a significant increase in regulated medical waste (RMW). Medical device waste is a major problem, with single-use devices (SUDs) accounting for approximately 90% of medical device waste in the U.S. healthcare system.

The scale of this challenge is tied to the company's success. In the third quarter of 2025 alone, U.S. revenue from handpieces and consumables reached $44.4 million, a 50% increase year-over-year, clearly illustrating the high volume of disposable units entering the healthcare waste stream. The handpieces are terminally sterilized using Ethylene Oxide (EtO), a process that itself carries environmental and regulatory scrutiny.

Encouraging suppliers to adopt similar environmental policies to manage supply chain impact

PROCEPT BioRobotics Corporation recognizes that its environmental impact extends beyond its own walls, particularly in a supply chain that sources components globally, including a third-party manufacturer for its ultrasound systems.

The company's stated policy is to encourage its suppliers and contract manufacturers to adopt similar environmental policies, focusing on waste reduction, recycling, and energy efficiency. This is a necessary first step, but it is currently a policy statement, not a quantified program. They need to defintely move toward a more formal supplier audit program that tracks environmental Key Performance Indicators (KPIs) like a supplier's resource efficiency or carbon footprint, which is a growing trend for major companies in 2025.

• Action: Formalize a supplier code of conduct that mandates environmental reporting.
• Action: Start tracking a minimum of 50% of key suppliers on a waste-to-revenue metric by the end of 2026.