Sensus Healthcare's Breakthrough CPT Codes and FDA Program: A Catalyst for 2026 Revenue Surge and Profitability

In late 2025, Sensus Healthcare (SRTS) emerged as a standout performer in the medical device sector, driven by a confluence of strategic milestones and market validation. The company's recent breakthroughs-namely, the finalization of new CPT codes for superficial radiation therapy (SRT) and robust growth in its FDA treatment program-position it as a prime candidate for a 2026 revenue surge. With a strong balance sheet, expanding global footprint, and reimbursement tailwinds, Sensus is leveraging capital allocation and operational momentum to unlock long-term value.

CPT Code Approval: A Game-Changer for Reimbursement and Adoption

The Centers for Medicare & Medicaid Services (CMS) finalized new CPT codes for SRT in non-melanoma skin cancer and keloid treatments in early November 2025, as noted in a Sensus Healthcare press release. This development marks a pivotal shift, as the updated codes provide a 300%+ increase in per-fraction reimbursement compared to prior rates, according to Sensus Healthcare's Seeking Alpha post. For Sensus, this means not only validation of its SRT-100, SRT-100+, and SRT-100 Vision devices but also a significant boost in the return on investment for dermatologists adopting the technology.

The reimbursement alignment with hospital outpatient rates is particularly impactful. As noted in a Q3 2025 earnings call, Sensus expects this to drive demand for its systems, as providers now have greater financial incentive to transition from surgical to non-invasive treatments, according to the Q3 2025 Earnings Call Transcript. This reimbursement certainty also reduces the risk of underutilization, a historical challenge for emerging therapies.

FDA Program Expansion: Sequential Growth and Operational Scalability

Sensus's FDA treatment program has been a key revenue driver, with treatment volumes surging 20% sequentially in Q3 2025 compared to Q2 and 52% compared to Q1, according to a Q3 2025 financial report. By September 30, 2025, the company operated 21 active FDA sites, with 11 additional sites pending activation, as reported in the same financial report. This expansion reflects both the scalability of its SRT systems and growing patient awareness of non-invasive alternatives to surgery.

The company's Q3 revenue of $6.9 million-exceeding the $6.25 million forecast-underscores the program's success, according to the Q3 earnings call. Notably, this growth occurred despite a decline in unit sales, suggesting that higher treatment volumes per device are now offsetting lower hardware demand. This shift signals a transition from a product-centric to a service-driven revenue model, a structural advantage for long-term profitability.

Strategic Capital Allocation: Fueling Innovation and Market Penetration

With $24.5 million in cash and no debt as of Q3 2025, according to the Q3 earnings call, Sensus is well-positioned to capitalize on its momentum. The company plans to allocate capital toward three key areas:
1. Demand Fulfillment: Scaling production to meet anticipated demand post-CPT code implementation.
2. R&D: Developing Sentinel 2.0, a software platform enabling advanced analytics for SRT systems, enhancing device utilization and patient outcomes, as discussed in the earnings call.
3. Global Expansion: Leveraging MDSAP certification to enter key international markets, including China, Japan, and Australia, according to the earnings call.

This disciplined approach contrasts with the capital constraints that often hinder smaller medtech firms. By prioritizing high-impact initiatives, Sensus is optimizing its balance sheet to drive both near-term revenue and long-term market share gains.

International Expansion: A New Frontier for Growth

Sensus's global ambitions are accelerating. The company has already shipped three SRT systems to China and plans to debut at Japan's JASTRO trade show in early 2026, according to the earnings call. MDSAP certification-a regulatory milestone required for market access in Canada, Brazil, Japan, and Australia-positions Sensus to replicate its U.S. success abroad.

This international diversification is critical for mitigating domestic market saturation risks. With skin cancer incidence rising globally and healthcare systems increasingly prioritizing cost-effective solutions, Sensus's non-invasive SRT technology is poised to disrupt traditional treatment paradigms.

2026 Revenue Projections: A Conservative Estimate with Upside Potential

While Sensus has not disclosed specific 2026 revenue targets, the trajectory of its Q3 performance and new reimbursement codes suggest a conservative estimate of $35–40 million in annual revenue. This projection assumes:
- A 50% sequential increase in treatment volumes post-CPT code implementation.
- Full activation of pending FDA sites by mid-2026.
- Steady international adoption, particularly in Asia-Pacific markets.

The company's cash reserves and low debt also provide flexibility to navigate regulatory or market headwinds, further insulating its growth story.

Conclusion: A Compelling Investment Thesis

Sensus Healthcare's recent milestones-CPT code approvals, FDA program expansion, and strategic capital deployment-create a virtuous cycle of revenue growth and market validation. As reimbursement certainty and international expansion drive adoption, the company is well-positioned to achieve profitability in 2026. For investors, Sensus represents a rare combination of regulatory tailwinds, operational scalability, and a clear path to sustainable value creation.