FocalTherics Narrows 2026 Revenue Outlook After Third-Quarter Slowdown

The Tip Desk · November 11, 2026 · 3 min read

Third-quarter revenue was $9.8 million, up 26% from a year earlier, as the company trimmed the top of its full-year range to $52.0 million.

FocalTherics (FOCL), a global leader in robotic focal therapy, reported third-quarter 2026 revenue of $9.8 million, a 26% increase from $7.8 million a year earlier, as year-over-year growth slowed from the 39% pace recorded in the second quarter.

The sequential drop from $13.2 million in the second quarter marked a cooling in the HIFU franchise after a strong mid-year. U.S. Focal One procedure volume rose 32% year-over-year in the third quarter, slower than the 47% increase in the second quarter.

The company sold seven Focal One capital systems in the quarter, versus six in the year-ago period, a 17% year-over-year increase that lagged the 44% unit growth of the second quarter, when it sold thirteen systems. The installed base still expanded to 192 systems, including 98 in the United States and 94 internationally, from 184 at the end of the second quarter.

Gross margin was 51.4%, compared with 46.6% in the prior-year period. The company said the increase was primarily attributable to improvement on standard cost of the Focal One and higher average selling price of Focal One systems and Focalpaks.

Sales of goods were $6.5 million, sales of RPP and leases $2.4 million, and sales of spare parts and services $1.0 million.

Operating expenses were $12.8 million, up from $10.3 million a year earlier. The company attributed the increase to incremental headcount-related compensation costs including higher stock-based compensation, and additional sales and marketing expenses related to various urology meetings and events. Operating loss was $7.8 million, compared with $6.7 million in the year-ago period.

Net loss was $4.5 million, or ($0.10) a share, compared with a net loss of $5.9 million, or ($0.16) a share, a year earlier. The company said the decrease was primarily attributable to a $2.6 million favorable non-cash impact related to the change in fair value of European Investment Bank warrants and a $0.5 million foreign-currency gain, partially offset by the higher operating loss and $0.4 million of interest expense on Tranche A and Tranche B drawdowns.

Cash, cash equivalents and short-term investments totaled $56.3 million as of September 30, 2026.

Chief Executive Officer Ryan Rhodes said the company demonstrated steady commercial momentum, highlighted by expanding adoption across multiple new regions and additional system sales in the United States, Turkey, Mexico, and France. He said U.S. procedure volumes accelerated year-over-year to 32% for the third quarter of 2026, compared with 15% in 2025, and that the company remains highly confident in its growth strategy as it closes out the year.

Commercial Focal One endometriosis programs expanded to three centers in Europe after the first commercial program launched in the second quarter. The company also said positive coverage policies were published by major commercial payers for HIFU in radiorecurrent prostate cancer.

FocalTherics narrowed full-year 2026 revenue guidance to $50.0 million to $52.0 million, representing 34% to 39% growth over 2025, from the prior range of $50.0 million to $54.0 million.