8-K: Sensus Healthcare Q3 Loss, CMS Coding Boosts Outlook

Sensus Healthcare reported a net loss of $0.9 million in Q3 2025, a significant decline from prior year income, despite new CMS coding validating SRT for non-melanoma skin cancer.

Summary

• Sensus Healthcare, Inc. announced financial results for the third quarter ended September 30, 2025, reporting revenues of $6.9 million, a 21.6% decrease from $8.8 million in Q3 2024.
• The company recorded a net loss of $0.9 million, or $0.06 per share, for Q3 2025, compared to a net income of $1.2 million, or $0.07 per diluted share, in Q3 2024.
• Adjusted EBITDA for Q3 2025 was negative $2.4 million, a significant drop from positive $1.6 million in Q3 2024.
• Gross profit decreased to $2.7 million (39.1% margin) in Q3 2025 from $5.2 million (59.1% margin) in Q3 2024, primarily due to lower sales and higher servicing/placement program costs.
• The company shipped 16 SRT systems in Q3 2025, down from 27 units in Q3 2024, with 10 units going to a large customer and three internationally to China.
• Fair Deal Agreement (FDA) treatment volume increased 20% over Q2 2025 and 52% over Q1 2025, with 21 active FDA sites and 11 pending to go live.
• Cash and cash equivalents stood at $24.5 million as of September 30, 2025, up from $22.1 million at December 31, 2024, with no outstanding debt.
• The Centers for Medicare & Medicaid Services (CMS) established first-ever dedicated CPT codes for Superficial Radiotherapy (SRT), validating its use for non-melanoma skin cancer and keloids, which is expected to strengthen adoption and reimbursement certainty.

Sentiment

Score: 5

Explanation: The sentiment is mixed. While the financial results for Q3 2025 show significant declines in revenue, gross profit, and a shift to net loss and negative Adjusted EBITDA, the announcement of new CMS CPT codes for SRT is a substantial positive development. This regulatory validation and improved reimbursement certainty could significantly boost future adoption and financial performance, offsetting the current operational challenges.

Positives

• CMS established first-ever dedicated CPT codes for SRT, validating its use for treating non-melanoma skin cancer and keloids, which is expected to provide compelling economics and reimbursement certainty.
• Fair Deal Agreement (FDA) treatment volume increased 20% over the second quarter of 2025 and 52% compared with the first quarter of 2025, indicating growing adoption and awareness.
• Exited the quarter with a strong cash position of $24.5 million and no debt.
• Possesses nearly 100 systems in inventory, positioning the company to respond quickly to market demand.
• A study published in Dermatologic Therapy demonstrated the efficacy of Sensus SRT combined with punch excision to treat keloids, reinforcing its versatility and medical relevance.

Negatives

• Revenues decreased by 21.6% to $6.9 million in Q3 2025 from $8.8 million in Q3 2024, primarily due to a lower number of units sold.
• Reported a net loss of $0.9 million, or $0.06 per share, in Q3 2025, a significant decline from a net income of $1.2 million, or $0.07 per diluted share, in Q3 2024.
• Gross profit decreased by 48.3% to $2.7 million in Q3 2025 from $5.2 million in Q3 2024, with gross margin falling to 39.1% from 59.1%.
• Adjusted EBITDA was negative $2.4 million in Q3 2025, compared to positive $1.6 million in Q3 2024.
• Cost of sales increased to $4.2 million in Q3 2025 from $3.6 million in Q3 2024, primarily due to higher servicing costs and the new placement program.
• Operating expenses increased across all categories: General and administrative (up to $1.9 million from $1.6 million), Selling and marketing (up to $1.5 million from $1.3 million), and Research and development (up to $1.8 million from $0.9 million).

Risks

• The possibility that inflationary pressures continue to impact sales.
• The level and availability of government and/or third-party payor reimbursement for clinical procedures using products, and the willingness of healthcare providers to purchase products if reimbursement declines.
• Concentration of customers in the U.S. and China, including the concentration of sales to one particular customer in the U.S.
• The development by others of new products, treatments, or technologies that render existing technology partially or wholly obsolete.
• Regulatory requirements applicable to the company and its competitors.
• Ability to efficiently manage manufacturing processes and costs.
• Risks arising from doing business in China and other foreign countries.
• Legislation, regulation, or other governmental action that affects products, taxes, international trade regulation (including tariffs), or other aspects of the business.
• The performance of the company's information technology systems and its ability to maintain data security.
• Ability to obtain and maintain the intellectual property needed to adequately protect products, and ability to avoid infringing or otherwise violating the intellectual property rights of third parties.
• Geopolitical uncertainties, such as the Middle East conflict and the Russian invasion of Ukraine, which have not had a significant impact to date but are continuously monitored.

Future Outlook

Management anticipates that the newly established CMS CPT codes for SRT will significantly strengthen adoption and provide reimbursement certainty, narrowing the gap between office-based and hospital outpatient rates. The company is also laying groundwork for broader international expansion following MDSAP certification and expects continued healthy utilization trends within its Fair Deal Agreement program. With nearly 100 systems in inventory, the company is well-positioned to meet future market demand and continues product development for next-generation systems.

Management Comments

• "Earlier this week, CMS published first-ever dedicated CPT codes for SRT that represents compelling economics and reimbursement certainty. These new codes narrow the gap between office-based reimbursement and hospital outpatient rates, and by leveling the playing field, they enable strengthening adoption for SRT," said Joe Sardano, Chairman and Chief Executive Officer.
• "We are extremely excited for our physician partners and customers, and especially for their patients, as this is clear validation of our SRT technology for treating non-melanoma skin cancer and keloids for years to come, supported by strong reimbursement."
• "Internationally, we are laying groundwork for broader expansion following our MDSAP certification and are seeing strong interest across select markets."
• "We shipped 16 SRT systems, including three to China, and saw healthy utilization trends within our Fair Deal Agreement program. FDA treatment volumes were up 20% over the second quarter and up 52% compared with the first quarter, underscoring the ongoing adoption among installed sites and the growing awareness of SRT and IG-SRT among patients and providers."
• "We exited the quarter with $24.5 million in cash and no debt. Importantly, with nearly 100 systems in inventory, we are well positioned to respond quickly to market demand."
• "This study [on keloids] is one of very few to examine punch excision debulking with SRT, and the findings reinforce SRTs versatility and medical relevance beyond aesthetics, helping further validate our technologys growing utility across multiple indications and procedures."

Industry Context

The establishment of dedicated CPT codes by the Centers for Medicare & Medicaid Services (CMS) for Superficial Radiotherapy (SRT) is a significant development for the medical device industry, particularly for companies specializing in non-invasive skin cancer and keloid treatments. This regulatory validation and improved reimbursement certainty are expected to accelerate the adoption of SRT technology, potentially leveling the competitive landscape between office-based and hospital outpatient settings. This move could drive broader market acceptance and utilization of SRT, impacting treatment protocols and patient access.

Stakeholder Impact

• Shareholders: Mixed impact, with poor financial performance offset by significant positive regulatory news (CMS CPT codes) that could drive future growth and valuation.
• Healthcare Providers/Customers: Positive impact due to clear validation of SRT technology and improved reimbursement certainty, potentially leading to increased adoption and utilization.
• Patients: Positive impact through strengthened access to validated SRT technology for treating non-melanoma skin cancer and keloids.
• Employees: Increased headcount in selling, marketing, and R&D suggests continued investment in growth areas, but overall financial performance could create uncertainty.

Next Steps

• Host an investment community conference call on November 6, 2025, to discuss financial results and provide a business update.
• Continue laying groundwork for broader international expansion following MDSAP certification.
• Continue to execute on strategic priorities across the business.
• Further product development related to next-generation systems.

Key Dates

Recommendation

The stock warrants a 'hold' recommendation due to a significant dichotomy in the filing. On one hand, the Q3 2025 financial results are notably weaker year-over-year, with substantial declines in revenue, gross profit, and a shift from net income to a net loss, alongside negative Adjusted EBITDA. This indicates operational challenges and reduced demand for units. However, the announcement of new, dedicated CMS CPT codes for Superficial Radiotherapy (SRT) is a highly material and positive development. This regulatory validation and improved reimbursement certainty could be a strong catalyst for future adoption, market expansion, and ultimately, a return to profitability. Investors should monitor the impact of these new codes on future sales and profitability before making a definitive 'buy' or 'sell' decision, as the long-term benefits could outweigh the short-term financial headwinds.

Keywords

Sensus Healthcare, SRT, Superficial Radiotherapy, Skin Cancer, Keloids, Medical Device, CMS CPT Codes, Financial Results, Q3 2025, Non-melanoma