EDAP TMS SA announced that its flagship High‑Intensity Focused Ultrasound (HIFU) platform generated record revenue in the fourth quarter of 2025, with HIFU sales projected between $12.9 million and $13.3 million (approximately €11.2 million–€11.6 million). Full‑year 2025 HIFU revenue is expected to reach $36.7 million to $37.2 million (€32.5 million–€32.9 million), the highest in the company’s history.
The company’s non‑core segment, which includes extralongitudinal shock‑wave lithotripsy (ESWL) and distribution, is projected to generate $7.9 million to $8.3 million in Q4 and $32.7 million to $33.1 million for the year. The decline in legacy businesses reflects a deliberate shift toward the higher‑margin HIFU platform, a strategy that has already begun to reshape the company’s revenue mix.
System placements of the Focal One platform reached a quarterly record of 15 units, and U.S. procedure volumes grew 28 % year‑over‑year. Annual system placements jumped 69 % from the prior year, underscoring the rapid adoption of the robotic platform in urology centers worldwide. These gains are driven by strong demand from hospitals and urology practices, as well as the company’s expanding portfolio of CE‑marked indications beyond prostate cancer.
CEO Ryan Rhodes highlighted the milestone, noting that “for the first time in the company’s history, HIFU revenue will represent more than half of total annual revenue.” He added that the record system placements and procedure growth reinforce the durability of the recurring revenue model and validate the company’s strategic pivot away from legacy products.
For 2026, EDAP TMS projects core HIFU revenue of $50.0 million to $54.0 million (€43.0 million–€46.0 million) and combined non‑core revenue of $22.0 million to $26.0 million (€19.0 million–€22.0 million). The guidance signals continued momentum for the robotic platform and a clear trajectory toward higher revenue and margin expansion as the company scales its high‑margin HIFU business. The company’s focus on HIFU is expected to drive profitability, even as it continues to invest in market expansion and reimbursement initiatives, such as the proposed Medicare payment rate increase for HIFU procedures in 2026.
EDAP TMS remains a leader in robotic energy‑based therapies, with the Focal One system positioned as a leading urologist‑controlled prostate focal therapy platform. The company’s strategic shift away from legacy ESWL and distribution businesses is already reflected in the revenue mix, and the strong guidance for 2026 indicates confidence in sustained demand and margin improvement. The company’s ongoing efforts to secure reimbursement and expand indications, including CE‑mark approval for deep infiltrating endometriosis, further support the long‑term growth outlook.
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