Profound Medical Corp.
Key statistics
from XBRL data in SEC filingsAI briefing
from the latest 10-K, 10-Q and 8-K eventsProfound Medical Corp. is a commercial-stage medical device company selling AI-powered, MRI-guided ablation systems, primarily the TULSA-PRO for prostate tissue.
What they do
Profound Medical develops and markets the TULSA-PRO system, which uses real-time MRI, robotically driven transurethral ultrasound, and closed-loop temperature feedback to ablate prostate tissue (malignant or benign). The company also commercializes the Sonalleve system, CE marked for uterine fibroids and bone metastases, and FDA-approved under an HDE for osteoid osteoma. Revenue comes from capital equipment sales and recurring one-time-use disposables plus related services.
Revenue drivers
- TULSA-PRO capital equipment — Sales of the TULSA-PRO system to hospitals and clinics; installed base reached 84 at end of Q2-2026.
- TULSA-PRO disposables and recurring services — One-time-use transurethral catheters and related services generate recurring revenue per patient procedure.
- Sonalleve system — Capital equipment sales for non-invasive ablation of uterine fibroids and other indications; smaller contributor than TULSA-PRO.
- Geographic expansion — Revenues generated in the US, EU, and Asia; regulatory approvals in China and South Korea for Sonalleve support international sales.
Recent performance
For Q2 2026, revenue was $2.5 million, down from $5.3 million in Q1 2026, with approximately $3.1 million of TULSA revenue shifted into early Q3 due to shipment timing. Six-month revenue was $7.82 million, up from $4.83 million in the prior year period, but net loss was $16.6 million for H1 2026. Full-year 2025 revenue was $16.1 million with a net loss of $42.6 million. Operating expenses declined 16% year-over-year in Q2 2026, and net loss improved 39% compared to Q2 2025.
Strategy
Management focuses on expanding commercial adoption of TULSA-PRO by driving clinical evidence (e.g., CAPTAIN trial), obtaining payer coverage (adding ~18.3 million covered lives in Q2 2026), and building a qualified sales pipeline (~$70 million). They are also exploring integration of PSMA PET imaging to support treatment decisions, and pursuing additional international regulatory approvals. The company continues to invest in R&D and clinical studies to support reimbursement and coverage.
Risks
- History of operating losses — The company has incurred significant net losses each year (e.g., $42.6 million in 2025) and expects continued losses, requiring additional capital.
- Capital intensity — The business is capital intensive and may need to raise funds through securities offerings or bank financings, which could dilute shareholders.
- Dependence on collaborators — The company relies on collaborative partners for sales, marketing, and distribution of some products, which may not perform as expected.
- Market acceptance risk — TULSA-PRO and Sonalleve may not achieve or maintain expected levels of market acceptance, limiting revenue growth.
Outlook
Management reiterates full-year 2026 revenue guidance of $25.0 million, citing strong commercial momentum including record new orders in Q2 and July. They expect continued payer coverage expansion and growing clinical validation to support growth. However, they caution that the qualified sales pipeline may not convert to revenue as expected.