New Dedicated CPT Codes for SRT and IGSRT
CMS awarded exclusive and dedicated CPT codes for SRT and IGSRT effective 01/01/2026, creating clear reimbursement for nonmelanoma skin cancer treatments and management commentary indicating a ~300% per-fraction reimbursement increase cited on the call.
Strong Balance Sheet — Cash and No Debt
Year-end cash and cash equivalents of $22.1M, unchanged from 2024, and no outstanding borrowings on the revolving credit facility, providing liquidity to fund growth and commercialization.
FDA Fair Deal Program – Rapid Usage Growth
Program ended 2025 with 18 active FDA sites and 10 pending activations; treatments in the program increased more than 8x year-over-year and number of patients treated increased by more than 250% year-over-year, demonstrating accelerating utilization and proof of concept.
Q4 Shipments and International Momentum
Shipped 14 systems in Q4 (8 U.S., 6 international, including China). Management called out international demand and margins as attractive and noted continued momentum in China, Taiwan, South Korea, and an expected Brazil regulatory clearance in 2026.
Commercial Scaling Plan and Sales Hiring
Company plans to expand the sales organization, having already added one rep and targeting 3–5 additional hires in 2026 to accelerate market education and lead conversion under the new reimbursement environment.
Inventory Build to Support Anticipated Demand
Inventories increased to $14.6M from $10.1M (up ~$4.5M, +44.6%), positioned as support for expected future system demand following reimbursement clarity.
Product and Regulatory Progress
Higher R&D investment to develop next-generation systems (R&D expense up to $7.8M from $4.2M, +85.7%), and MDSAP certification enabling broader international opportunity; management previewed Sentinel 2.0 and other product initiatives.
Guidance and Outlook
Management expects Q1 2026 system shipments to exceed Q4 2025 levels (explicitly excluding contribution from the historically largest customer) and reiterated the objective of achieving full-year profitability in 2026.