Edap Tms NASDAQ: EDAP reported what management described as a “strong first quarter” for 2026, highlighted by record first-quarter revenue and continued momentum in its high-intensity focused ultrasound (HIFU) business centered on the company’s Focal One robotic platform.
Record quarterly revenue driven by HIFU growth
Chief Executive Officer Ryan Rhodes said the company delivered “record first quarter total revenue for the company of $17.8 million,” led by “record first quarter Focal One robotic HIFU revenue of $11.6 million.” Rhodes said the HIFU segment has now posted “seven consecutive quarters of year-over-year growth,” which he attributed to increasing physician adoption, expanding utilization, and rising global demand.
Chief Financial Officer Ken Mobeck said total revenue increased 25% year over year from $14.3 million in the first quarter of 2025 to $17.8 million in the first quarter of 2026. HIFU revenue rose to $11.6 million from $6.5 million a year earlier, representing 78% growth. Mobeck said that increase was driven by 11 Focal One capital sales in the quarter, up from six in the prior-year period, along with a 30% increase in treatment-driven revenue.
Mobeck noted that growth in HIFU was “partially offset” by declines in the company’s non-core distribution and extracorporeal shock wave lithotripsy (ESWL) businesses, which fell 20% compared with the year-ago quarter.
System placements expand across U.S. and international markets
Rhodes said EDAP recorded 11 capital sales and 10 total net placements during the quarter. In the U.S., he pointed to adoption at major academic cancer centers, including University of Pittsburgh Medical Center (UPMC), which “converted to a cash sale,” and Moffitt Cancer Center, where Rhodes said the placement marked the “10th Focal One system installed in the state of Florida.”
Rhodes also said EDAP placed a second Focal One system within the Mass General Brigham network, adding that 11 U.S. hospital and health networks have now launched “two or more” Focal One programs.
Internationally, EDAP reported a record six capital sales in the first quarter, with Rhodes citing particularly strong performance in Europe. In France, the company completed what it described as its first cash sale following a French National Health Insurance decision to provide universal coverage for the Focal One HIFU procedure. Rhodes said the coverage decision was supported by results from the HIFI study, which he described as a large prospective comparative trial evaluating Focal One robotic HIFU against radical prostatectomy in prostate cancer.
Rhodes said the quarter also marked the first time Focal One capital sales were driven by demand across two clinical indications—prostate cancer and deep infiltrating endometriosis—positioning the system as a multi-specialty platform. He cited Cleveland Clinic London’s conversion to a cash sale, supported by engagement from both urology and gynecology departments, and EDAP’s first cash sale in Hungary, which he said was tied to treating both prostate cancer and endometriosis.
In the Americas outside the U.S., Rhodes said EDAP delivered its first Focal One system in Mexico, adding to a regional footprint that includes Brazil, Argentina, Chile, Panama, and Mexico.
Utilization trends: U.S. procedures up 53%
Rhodes said utilization continued to rise, with U.S. procedure volumes increasing 53% year over year. On the Q&A portion of the call, Rhodes told Jefferies analyst Michael Sarcone that the growth reflected several factors, including increased demand for non-radical treatments, maturation of customer programs, more physician training, and the expanding installed base. He said EDAP is “getting better at ramping programs,” and emphasized the company’s focus on procedure growth as a key metric tied to revenue and margin.
When asked about physician adoption within accounts, Rhodes said EDAP has progressed from roughly “1.5” trained doctors per site to “nearly two per site, two or more,” with some locations having as many as six trained urologists. He said the number varies by institution and that EDAP is “a little more prescriptive now” in targeting broader training as it launches new programs.
Clinical and indication expansion: salvage post-radiation, BPH, and endometriosis
Rhodes highlighted EDAP’s efforts to expand Focal One’s clinical utility, including within prostate cancer recurrence following failed radiation therapy. He discussed the company’s announcement around a peer-reviewed publication of the HIFI-2 study, which he called the largest prospective study in salvage treatment after radiation therapy failure, enrolling more than 500 patients. Rhodes said the study showed “clinically meaningful oncologic control,” with 71% of patients avoiding hormone deprivation therapy at 30 months, and 84% avoiding it in a rigorously selected subgroup.
Rhodes also noted that National Comprehensive Cancer Network (NCCN) guidelines already recommend HIFU as a treatment option for prostate cancer recurrence following failed radiation therapy, and that Medicare and commercial payers currently reimburse for use of Focal One robotic HIFU in that setting.
Beyond prostate cancer, Rhodes said EDAP is accelerating clinical studies evaluating Focal One for benign prostatic hyperplasia (BPH). He said EDAP collaborated with urologists from the Icahn School of Medicine at Mount Sinai to treat patients in Chile as part of a research study and plans to enroll a second cohort in the coming months. He also said a separate IRB-approved study will be conducted at Mount Sinai in New York following evaluations from the Chile study.
In gynecology, Rhodes said EDAP’s commercial rollout for endometriosis is gaining momentum across Europe and that first patient treatments at several new clinical centers are expected “in the coming weeks.” He also said investigators presented positive long-term follow-up data from phase II and phase III randomized controlled trials at recent European meetings.
On U.S. endometriosis efforts, Rhodes told Sarcone the company is waiting for published data from a randomized controlled trial with follow-up approaching 24 months, including follow-up in patients from the sham arm who later received treatment. He said EDAP expects publication “likely sometime this year,” and that it will be important for revisiting the company’s strategy with the FDA.
Margins improve as mix shifts to HIFU; guidance reiterated
Mobeck reported first-quarter gross profit of $8.1 million, up from $6.0 million a year earlier. Gross margin improved to 45.7% from 42%, which he attributed primarily to a “strategic shift” toward the higher-margin HIFU segment. He said HIFU gross margin was 51.4% in the quarter compared to 48.6% in the first quarter of 2025.
Operating expenses increased to $15.5 million from $12.3 million, driven by higher sales expense associated with increased system sales and “incremental costs” related to EDAP’s transition to a U.S. domestic filer. Operating loss widened to $7.4 million from $6.3 million.
Net loss was $9.1 million, or $0.24 per share, compared with a net loss of $7.4 million, or $0.20 per share, in the prior-year quarter. Mobeck said the increase was driven by a $1.1 million higher operating loss and a $1.7 million non-cash charge related to warrants and interest expense on the European Investment Bank tranche A drawdown, partially offset by a $1.1 million positive currency impact.
On the balance sheet, Mobeck said cash and cash equivalents were $15.0 million at quarter-end, down from $20.5 million at the end of the fourth quarter of 2025, primarily due to cash used in operating activities tied to strategic investments. Inventory increased to $13.3 million from $12.8 million sequentially, which Mobeck said was due to higher HIFU-related inventory to meet demand. He also said tariff impact on the first-quarter P&L and balance sheet was approximately $400,000.
EDAP reiterated full-year 2026 guidance. Mobeck said the company continues to expect core HIFU revenue of $50 million to $54 million, representing 34% to 45% growth over 2025, and combined non-core revenue of $22 million to $26 million. In response to a question from Piper Sandler’s Jason Bednar, Mobeck also said that implied guidance includes the U.S. accounting for a disproportionate amount of system sales mix.
Looking ahead, Rhodes highlighted upcoming commercial and investor-focused events, including a CME-accredited physician training course at Memorial Sloan Kettering Cancer Center on May 14, EDAP’s presence at the American Urological Association meeting starting May 15, and an investor day on June 1 at the Nasdaq MarketSite in New York.
About Edap Tms NASDAQ: EDAP
Edap Tms SA NASDAQ: EDAP is a Lyon, France–based medical device company that develops and markets noninvasive therapeutic systems for urological applications. The firm's core focus lies in high-intensity focused ultrasound (HIFU) for localized prostate tissue ablation and extracorporeal shock-wave lithotripsy for kidney stone fragmentation. Edap Tms's Ablatherm HIFU platform delivers targeted ultrasound energy to treat prostate cancer without incisions, while its Sonolith line offers pulse-focused shock waves designed to break down urinary calculi.
Since its founding in 1989, Edap Tms has pursued regulatory clearances in multiple markets, including CE marking in Europe and FDA clearance for its HIFU system in the United States.
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