Sensus Healthcare, Inc. (SRTS): Business Model Canvas [Dec-2025 Updated]

You're looking to see how a medical device company pivots its entire revenue engine, and the structure for Sensus Healthcare, Inc. (SRTS) is a textbook case right now. Honestly, after two decades analyzing these plays, what stands out is their aggressive shift from just selling Superficial Radiation Therapy (SRT) systems to locking in recurring revenue through the Fair Deal Agreement (FDA) model, all while sitting on a clean $24.5 million cash pile as of September 30, 2025. With revenue hitting $22.5 million in the first nine months of 2025, the real question is whether the new CMS reimbursement codes will fuel enough volume to make that recurring stream truly scalable; let's break down the nine blocks of their strategy below.

Sensus Healthcare, Inc. (SRTS) - Canvas Business Model: Key Partnerships

You're looking at the core relationships Sensus Healthcare, Inc. (SRTS) relies on to get its Superficial Radiotherapy (SRT) systems into the market and drive recurring revenue. These partnerships are critical for navigating the complex U.S. healthcare system and achieving global scale.

Radiology Oncology Systems (ROS) for U.S. Hospital-Based Oncology Distribution

Sensus Healthcare, Inc. engaged Radiology Oncology Systems (ROS) as its primary distribution partner for the U.S. radiation oncology market, effective June 26, 2025. ROS is responsible for selling the SRT-100 and SRT-100 Vision systems to hospital-based radiation oncology departments and freestanding oncology centers nationwide. Initial orders under this agreement were expected as early as the fourth quarter of 2025.

MedIQ Healthcare Solutions, LLC for Dedicated Customer Reimbursement Support

Sensus Healthcare, Inc. partners with MedIQ Healthcare Solutions, LLC to provide dedicated customer reimbursement support, a necessary function given the evolving Centers for Medicare & Medicaid Services (CMS) coding environment.

International Distributors for Expansion

International expansion is underway, supported by the receipt of MDSAP certification, which allows for immediate access to markets including Japan and Brazil. System shipments to China occurred in both Q2 2025 (4 units) and Q3 2025 (3 units). Management anticipates international revenues to grow to about 20% of total revenue within 12-24 months, up from the current range of 5-10%. The global installed base surpassed 900 systems as of Q3 2025, with a target of 1,000 systems in 2026.

Large Corporate Accounts Driving Volume through Fair Deal Agreements (FDAs)

The Fair Deal Agreement (FDA) program is a key recurring revenue driver, linking revenue directly to patient treatment volume. Utilization within this program showed strong sequential growth, with treatment volumes increasing 20% from Q2 to Q3 2025, and a 52% increase compared to Q1 2025. Since its launch in late 2024, quarterly treatment volumes have grown by 157%. As of Q3 2025, 21 FDA sites were active, with another 11 pending to go live. In Q2 2025, 5 new FDAs were signed, with 4 sites activated. One large customer accounted for 10 unit shipments in Q2 2025.

Here's a quick look at the system placements and FDA utilization trends through Q3 2025:

Clinical Research Organizations for Studies Validating SRT Efficacy on Keloids

Validation of SRT efficacy for non-oncological conditions is supported by published research. A study in Dermatologic Therapy demonstrated the efficacy of Sensus' SRT combined with punch excision to treat keloids. This clinical validation supports the new CMS CPT codes, which specifically include keloids. The reimbursement per fraction for SRT delivery codes saw an increase of more than 300% compared to the codes previously used.

Sensus Healthcare, Inc. (SRTS) - Canvas Business Model: Key Activities

You're looking at the core engine of Sensus Healthcare, Inc. (SRTS) operations as of late 2025. This is where the rubber meets the road, turning R&D into tangible products and securing the revenue streams that keep the lights on. Honestly, the numbers tell a story of shifting focus from pure hardware sales to service-driven revenue.

Manufacturing and Shipping SRT Systems

The company's manufacturing activity is directly tied to system placements. For the first nine months of 2025, Sensus Healthcare shipped 56 units, which is a notable drop from the 76 units shipped in the same period of 2024. This decline in unit volume is a major factor influencing the year-to-date revenue figures.

Here's a quick look at the quarterly system shipments for the first three quarters of 2025:

The Q1 shipment included 15 units to a large customer, and Q3 included 10 units to that same large customer. The global reach is starting to build, with one unit shipped internationally in Q1 and four to China in Q2.

Research and Development (R&D) for New Products

Research and development is a major operational cost, reflecting the push for future products and regulatory support. For the first 9 months of 2025, Research and development expense totaled $5.9 million, a significant increase from $2.7 million for the same period in 2024. The Q3 2025 R&D spend alone was $1.8 million. This spending is explicitly tied to:

• Significant lobbying costs related to the billing code reimbursement.
• Higher head count and product development costs related to next-generation systems.
• Ongoing product development and readiness for the anticipated TDI (TransDermal Infusion) commercialization.

Also, management announced the initiation of a multiphase R&D program for Sentinel 2.0, with initial results expected in 2026.

Lobbying and Advocacy for Favorable Medicare Reimbursement (CPT Codes)

Advocacy efforts culminated in a major win: the Centers for Medicare & Medicaid Services (CMS) published first-ever dedicated Current Procedural Terminology (CPT®) codes for superficial radiotherapy (SRT) for non-melanoma skin cancer. This validation, included in the 2026 Physician Fee Schedule, represents an increase in reimbursement per fraction of more than 300% compared with previous codes. This is designed to narrow the gap between office-based reimbursement and hospital outpatient rates.

Managing the Fair Deal Agreement (FDA) Program and Recurring Treatment Volume

The Fair Deal Agreement (FDA) program is clearly a key activity driving recurring revenue, even as unit sales dipped. FDA treatment volume showed strong sequential growth:

• Q1 2025 saw a 65% increase in treatment volume from FDA systems over the preceding quarter.
• Q2 2025 volume increased 27% sequentially versus Q1.
• Q3 2025 volume increased 20% over Q2 2025 and 52% compared to Q1 2025.

By September 30, 2025, the company reported 21 active FDA sites, with 11 additional sites pending activation.

Global Regulatory Compliance and Commercial Expansion

A significant operational milestone achieved was receiving Medical Device Single Audit Program (MDSAP) certification for the entire portfolio of superficial radiation therapy (SRT) systems. This certification is intended to streamline regulatory compliance and accelerate commercial expansion into key global markets, including Brazil, Canada, Japan, and Australia. Management expects the TransDermal Infusion (TDI) product, upon FDA clearance, to also be granted MDSAP certification.

Finance: review the impact of the $5.9 million YTD R&D spend on the $4.6 million net loss for the first 9 months of 2025 by Monday.

Sensus Healthcare, Inc. (SRTS) - Canvas Business Model: Key Resources

You're looking at the core assets Sensus Healthcare, Inc. (SRTS) relies on to execute its business plan as of late 2025. These aren't just line items; they are the foundation of their market position.

The company's financial strength and physical assets provide a solid base for near-term operations and planned growth.

The proprietary technology itself is central, validated by recent regulatory and clinical milestones.

• Proprietary Superficial Radiation Therapy (SRT) technology, including the SRT-100 and SRT-Vision platforms.
• Intellectual property portfolio supporting the SRT devices.
• MDSAP certification achieved, supporting international quality management system compliance.
• FDA clearances underpinning the technology's use.
• New dedicated CPT® codes established by the Centers for Medicare & Medicaid Services (CMS) validating SRT for non-melanoma skin cancer treatment.

Also critical are the people who sell and support these complex devices. You need experts to drive adoption.

• Specialized sales personnel focused on the SRT systems.
• Clinical support personnel for site activation and ongoing use.

Sensus Healthcare, Inc. (SRTS) - Canvas Business Model: Value Propositions

You're looking at the core reasons why dermatology practices would adopt Sensus Healthcare, Inc.'s technology right now, especially given the late 2025 financial environment. The value propositions are centered on clinical superiority, economic upside, and ease of access.

Highly effective, non-invasive treatment for non-melanoma skin cancer and keloids

The clinical data definitely supports the claim of high efficacy for non-melanoma skin cancer (NMSC). You have long-term follow-up showing durable results, which is what matters most for a treatment modality.

• It is estimated that 98.9% of NMSC will not recur after 85 months following superficial radiation therapy (SRT).
• A retrospective study confirmed a 98.9 percent cure rate across 776 NMSC lesions treated in 516 patients.
• A study published in September 2025 demonstrated the efficacy of Sensus Healthcare's SRT when combined with punch excision specifically for treating keloids.

Patient-centric, non-surgical alternative to excision with minimal scarring

For patients, the value is clear: avoiding surgery and the associated recovery. This is particularly relevant for the demographic Sensus often treats.

• The patient population in one key efficacy study had a mean age of 79 years, highlighting suitability for elderly patients who may have comorbidities limiting surgical options.
• The technology provides a non-invasive option, empowering patients to choose therapy without the risks and recovery associated with surgery.

Cost-effective system acquisition through the Fair Deal Agreement (FDA) program

The Fair Deal Agreement (FDA) program is designed to remove the major hurdle for office adoption-the upfront capital outlay. This shifts the model to a service-based revenue alignment for the practice.

The momentum in the program itself shows adoption is accelerating, which validates the model's appeal to new customers. The company ended Q3 2025 with inventory ready to meet this growing demand.

New CMS CPT codes strengthening the ROI for office-based dermatology practices

This is the financial game-changer you've been tracking. The Centers for Medicare & Medicaid Services (CMS) finalized dedicated Current Procedural Terminology (CPT) codes for SRT in November 2025. This provides the reimbursement certainty needed for practices to commit.

Here's the quick math on the economic impact:

• Reimbursement per treatment fraction increased by more than 300% compared to prior codes.
• The new codes align office-based reimbursement closer to hospital outpatient rates, directly strengthening the Return on Investment (ROI) for dermatology offices.
• The company ended Q3 2025 with $24.5 million in cash and reported no debt, giving it a strong balance sheet to support this commercial push.

Analysts are projecting a potential annual revenue of $35-$40 million for 2026, based on this reimbursement certainty driving adoption.

Integrated Image-Guided SRT (IG-SRT) for precise tumor visualization

The technology itself is differentiated by its guidance system. Sensus manufactures and sells the only proven, FDA-cleared IG-SRT system that integrates ultrasound.

• The SRT-100 Vision system uses high-frequency ultrasound for precise treatment planning.
• The technology covers 33 individual claims, supporting a streamlined and efficient treatment process for providers.

Finance: draft 13-week cash view by Friday.

Sensus Healthcare, Inc. (SRTS) - Canvas Business Model: Customer Relationships

You're looking at how Sensus Healthcare, Inc. (SRTS) keeps its customers engaged and supported, which is crucial given the device's capital cost and the reliance on consistent reimbursement. The relationships here are built on service, long-term contracts, and regulatory advocacy.

Dedicated Reimbursement Support Services via a Third-Party Partner

Sensus Healthcare, Inc. has outsourced the heavy lifting for navigating payer issues. They partner with MedIQ Healthcare Solutions, LLC to provide reimbursement support for all customers. You can reach their hotline consultants Monday through Friday, from 8:30 AM to 6:00 PM EST. This dedicated support is a key part of reducing friction for new and existing users.

High-Touch, Long-Term Engagement Through the Fair Deal Agreement (FDA) Model

The Fair Deal Agreement (FDA) model is clearly central to their recurring revenue strategy and customer stickiness. This shared-services program lets dermatology practices use the SRT systems with flexible financial terms. The commitment here is showing up in the usage metrics:

This recurring revenue stream from the FDA model partially offset revenue decreases in the second quarter of 2025. Furthermore, the Centers for Medicare & Medicaid Services (CMS) established first-ever dedicated CPT codes for SRT in late 2025, which management projects will raise the per-fraction delivery reimbursement by "300%+," a catalyst for future adoption.

Direct Sales Force and Clinical Application Training

The company invests in its commercial team to drive adoption and support. Selling and marketing expenses for the third quarter of 2025 hit $2.2 million, up from $1.3 million in the third quarter of 2024, with the increase reflecting higher headcount and payroll costs tied to commissions. For the first half of 2025, selling and marketing expense totaled $3.6 million, up from $2.3 million in the first half of 2024, driven by payroll increases and clinical study costs. This spend supports the direct sales effort and the necessary clinical application training.

Investor Relations and Consistent Communication on Regulatory Developments

Investor relations is actively managed, with Alliance Advisors IR handling communications as of August 2025. You saw consistent communication around major regulatory events throughout 2025. For instance, the company discussed the proposed Local Coverage Determination (LCD) in May 2025 and later announced the CMS CPT code finalization in November 2025. Research and development expense for the first half of 2025 was $4.1 million, which included significant lobbying costs related to billing code reimbursement. The company held quarterly calls to update stakeholders, such as the Q2 2025 call on August 7, 2025, and the Q3 2025 call on November 6, 2025.

Here's a snapshot of the financial context surrounding these regulatory efforts:

• Selling and marketing expenses in Q1 2025 rose due to participation in major industry events.
• General and administrative expenses for the first nine months of 2025 were $6.1 million, up from $4.7 million in the prior year, reflecting higher professional fees and insurance costs.
• The company exited Q3 2025 with $24.5 million in cash and no debt.

Participation in Major Medical Conferences to Build Awareness and Trust

Sensus Healthcare, Inc. uses major medical meetings to directly engage with current and prospective customers. In the first quarter of 2025, they showcased their SRT systems at two key events:

• The 2025 Winter Clinical Dermatology Conference.
• The 2025 American Academy of Dermatology (AAD) Annual Meeting.

At the AAD meeting, they hosted a successful event for customers and prospects featuring Olympic swimmer Katie Ledecky. The focus on these events is clear; selling and marketing expenses in Q2 2025 increased due to higher tradeshow expenses and costs related to clinical studies. Also, to broaden awareness of the FDA program, management noted they are now participating in a number of smaller dermatology conferences nationwide.

Sensus Healthcare, Inc. (SRTS) - Canvas Business Model: Channels

You're looking at how Sensus Healthcare, Inc. (SRTS) gets its SRT systems and services into the hands of doctors as of late 2025. The channel strategy is clearly a mix of direct sales for core US markets and leveraging programs for recurring revenue, plus a growing international push.

Direct sales team focused on dermatology and radiation oncology practices.

The core of the domestic channel relies on direct sales efforts targeting both dermatology and radiation oncology centers. This is where the capital equipment sales happen, though the Fair Deal Agreement (FDA) model is shifting the focus toward utilization revenue. For instance, in the third quarter of 2025, Sensus Healthcare shipped a total of 16 SRT systems. This included 10 units going to a single large customer, showing a continued reliance on major accounts for upfront system sales. The global installed base reached over 900 systems by the end of Q3 2025, with a stated goal to hit the 1,000 system milestone in 2026.

Fair Deal Agreement (FDA) program, an operating lease-like placement model.

This placement model is a critical channel for driving utilization, which is where the recurring revenue comes from. The FDA program allows practices to adopt the SRT-100 Vision system without significant upfront capital, linking their cost directly to patient treatment volume. The traction here is defintely improving; treatment volumes under the FDA program increased by 20% from the second quarter of 2025 and showed a 52% increase compared to the first quarter of 2025. As of the end of Q3 2025, there were 21 active FDA sites, with another 11 pending to go live. This model is supported by the new CMS CPT codes, which management noted represent an increase in reimbursement per fraction of more than 300% compared to prior codes.

Third-party international distributors for global system sales.

International expansion is a clear channel priority, supported by regulatory milestones like achieving MDSAP certification for the full product portfolio. In Q3 2025, 3 of the 16 shipped systems went to China, indicating active international distribution. Management is setting an expectation that international revenues will climb to about 20% of total revenue within the next 12-24 months, up from the current range of 5-10%. This suggests an increasing reliance on distributors and partners to penetrate markets outside the US.

Here's a quick look at how the key channels are performing based on the latest reported figures:

Medical tradeshows (e.g., AAD, Winter Clinical Dermatology Conference).

Industry events remain a vital channel for lead generation and awareness, especially for the FDA program. In the first quarter of 2025, Sensus Healthcare showcased its systems at both the 2025 Winter Clinical Dermatology Conference and the 2025 American Academy of Dermatology (AAD) Annual Meeting. The increased selling and marketing expense in Q3 2025 to $2.2 million, up from $1.3 million the prior year, reflects, in part, the investment in these major industry events and associated payroll for commissions. Also, the company attended the European Society of Therapeutic Radiation Oncology (ESTRO) show in Vienna, signaling a targeted approach to radiation oncology channels.

Online presence and investor relations for market communication.

The company uses its online presence, specifically the Investor Relations section of the Sensus Healthcare website, as a primary channel for official communication, hosting SEC Filings and Press Releases. Furthermore, they actively manage the perception of the technology's economic viability through support partnerships. Sensus Healthcare partners with MedIQ Healthcare Solutions, LLC to provide reimbursement support for all customers, which is a crucial channel for ensuring the ongoing utilization of the systems sold and placed. You can reach MedIQ for support at phone number 302-602-1078.

Sensus Healthcare, Inc. (SRTS) - Canvas Business Model: Customer Segments

You're looking at the core buyers for Sensus Healthcare, Inc. (SRTS) as of late 2025. The focus is clearly segmented between high-volume domestic users, growing international markets, and a specific segment tied to their Fair Deal Agreement (FDA) program.

U.S. Dermatology practices and multi-site corporate accounts are heavily targeted through the FDA program, which is designed to build recurring revenue from treatment volumes. By the end of the third quarter of 2025, Sensus Healthcare reported having 21 FDA sites active, with another 11 pending activation. This segment is showing traction in usage, evidenced by a 20% sequential increase in FDA treatment volume from the second quarter of 2025 to the third quarter of 2025, and a 52% increase when compared to the first quarter of 2025.

For Hospital-based radiation oncology departments and freestanding cancer centers, Sensus Healthcare engaged Radiology Oncology Systems (ROS) in the second quarter of 2025 to serve as a primary distribution partner. This move signals a direct push into institutional settings, which often involve higher capital expenditure budgets and larger patient throughput for non-melanoma skin cancer and keloid treatments.

The company is actively pursuing International healthcare providers in markets like China, Brazil, and Japan. System shipments confirm activity, with a total of 8 SRT systems shipped internationally in the first nine months of 2025. Specifically, shipments to China accounted for 3 units in the third quarter of 2025 and 4 units in the second quarter of 2025. The company received MDSAP certification for its full SRT product portfolio, which supports this global regulatory access and commercial expansion.

The segment of Large, single customers who purchase significant unit volumes remains a key, albeit volatile, part of the hardware sales cycle. In the third quarter of 2025, Sensus Healthcare shipped 16 total SRT systems, with 10 of those units going to a single large customer. This reliance is noted, as the year-to-date unit sales for the first nine months of 2025 totaled 56 units, down from 76 units in the same period in 2024, with the decrease attributed to lower purchases from this major buyer.

Finally, the ultimate end-users, Patients seeking non-surgical treatment for non-melanoma skin cancer and keloids, are the beneficiaries of the new reimbursement certainty. The Centers for Medicare & Medicaid Services (CMS) established first-ever dedicated CPT codes for SRT, which management noted provides a per-fraction delivery reimbursement increase of more than 300%, expected to stabilize the return on investment for physician offices.

Here's a quick look at the system shipment distribution for the first three quarters of 2025:

The company's ability to service these segments is backed by a strong balance sheet, exiting the third quarter of 2025 with $24.5 million in cash and no debt, plus having nearly 100 systems in inventory ready to meet demand.

The growth drivers within the customer base include:

• FDA treatment volume growth of 52% from Q1 2025 to Q3 2025.
• 21 active FDA sites as of September 30, 2025.
• Total SRT systems shipped year-to-date 2025: 56 units.
• International shipments YTD 2025: 8 units.

Sensus Healthcare, Inc. (SRTS) - Canvas Business Model: Cost Structure

You're looking at the expense side of the Sensus Healthcare, Inc. (SRTS) operations as of late 2025, which is heavily influenced by system servicing, sales efforts, and strategic investments in lobbying and product development. Honestly, the cost structure reflects a company navigating reimbursement changes while pushing growth initiatives like the Fair Deal Agreement (FDA) program.

Here's a breakdown of the key components of the cost structure for the nine months ended September 30, 2025 (9M 2025), unless otherwise noted:

The Cost of Sales figure of $12.6 million for 9M 2025 compares to $11.4 million in the prior year period. Gross margin compressed to 44.4% in 9M 2025 from 60.3% in 9M 2024, driven by lower sales, higher servicing costs, and the costs tied to the new placement program.

Research and Development (R&D) spending saw a significant jump, reaching $5.9 million for the nine months ended September 30, 2025, up from $2.7 million in the same period last year. This increase reflects substantial lobbying costs related to billing code reimbursement, higher headcount, and increased product development costs for next-generation systems.

The costs associated with the Fair Deal Agreement (FDA) placement program are embedded across several expense lines, particularly Cost of Sales and S&M, due to commissions. The program itself is a key driver of activity, though it also contributes to cost pressures.

Key details regarding the FDA program and associated costs/activities include:

• FDA treatment volume increased 20% sequentially in Q3 2025 over Q2 2025.
• FDA treatment volume increased 52% in Q3 2025 compared to Q1 2025.
• The program is designed to alleviate upfront capital costs for practices.
• Selling and marketing expenses in Q3 2025 reflected higher payroll costs due to commissions related to the new placement program.
• The program links revenue generation directly to patient treatment volume.
• As of Q3 2025, 21 FDA sites were active with 11 pending to go live.

Selling and Marketing (S&M) expense for Q3 2025 was reported at $2.2 million, up from $1.3 million the prior year, reflecting higher headcount and payroll costs tied to commissions. For the same quarter, G&A was $1.8 million compared to $900,000 in Q3 2024.

Finance: draft 13-week cash view by Friday.

Sensus Healthcare, Inc. (SRTS) - Canvas Business Model: Revenue Streams

The Revenue Streams for Sensus Healthcare, Inc. are built upon a dual approach, combining upfront capital equipment sales with an increasingly important recurring revenue component tied to treatment volume.

The primary sources of revenue are:

• Capital equipment sales of SRT systems, specifically the SRT-100 and SRT-Vision models.
• Recurring revenue generated from the Fair Deal Agreement (FDA) program, which directly links revenue to patient treatment volume.
• Revenue from service and maintenance contracts associated with the installed base of systems.

Financially, the performance as of late 2025 shows the following top-line figures:

You can see the direct impact of unit sales, which represent the capital equipment portion, on the nine-month results. For the first nine months of 2025, the company shipped a total of 56 SRT systems. This compares to 76 units shipped in the same period of 2024.

The Fair Deal Agreement is designed to be a recurring revenue stream, which is key for future stability. For the third quarter of 2025, the FDA treatment volume showed positive momentum:

• FDA treatment volume increased 20% over the second quarter of 2025.
• FDA treatment volume increased 52% compared with the first quarter of 2025.

This recurring revenue from the FDA program slightly offset the overall revenue decrease seen in the first nine months of 2025, which was primarily due to fewer unit sales to a large customer. The company is positioning itself for future recurring revenue growth, as evidenced by having nearly 100 systems in inventory ready for deployment. The service and maintenance component is implicitly captured within the overall revenue structure, with higher costs of servicing systems noted as a factor impacting gross margin in the 2025 period.

Here's a breakdown of the system sales activity that drives the capital equipment revenue stream:

Finance: draft 13-week cash view by Friday.