Edap Tms Talks Surging HIFU Demand, Focal One i Launch and Reimbursement Tailwinds at Conference

Key Points

• Focal One i and clinical evidence: EDAP says rising global demand for HIFU positions its newly launched Focal One i (April 2025) as an organ‑preserving first‑line and salvage prostate cancer therapy, supported by over 1,000 publications and large trials (HIFI: 3,328 patients; FARP: non‑inferiority with superior functional outcomes).
• Reimbursement and adoption tailwinds: Medicare HIFU claims grew exponentially from 2022–2024 and a January payment change increased APC6/CPT 55880 reimbursement by ~4.3%, narrowing the gap to surgeon pay and coinciding with growing adoption (87 U.S. and 41 European Focal One systems reported).
• Pipeline expansion beyond prostate cancer: EDAP is advancing BPH studies with an IRB‑approved U.S. academic site expected to treat patients in the first half of the year, and has a CE‑marked limited launch in Europe for deep infiltrating endometriosis.

EDAP management highlighted what it sees as a growing global opportunity for therapeutic ultrasound in urology, emphasizing the company’s Focal One robotic high-intensity focused ultrasound (HIFU) platform and its expanding clinical evidence base, installed footprint, and reimbursement support. The comments were delivered by CEO Ryan Rhodes and CFO Ken Mobeck during a conference session hosted by Oppenheimer medical device analyst Suraj Kalia.

Large and growing prostate cancer opportunity

Rhodes framed Edap Tms NASDAQ: EDAP as a “global leader in therapeutic ultrasound,” with a primary focus on prostate cancer and other benign and malignant diseases. He cited nearly 1.5 million newly diagnosed prostate cancer cases each year across six global regions and referenced a Lancet Commission projection that annual diagnoses will increase to 2.9 million by 2040.

Rhodes described prostate cancer as a heterogeneous disease in which treatment varies by risk stratification. He said low-risk patients may remain on active surveillance, while high-risk patients often receive radical treatments such as surgery and radiation. EDAP’s target, he said, is the “gap” between these extremes—patients spanning low to intermediate risk (and some higher-risk categories)—where Focal One robotic HIFU is positioned as an organ-preserving, first-line treatment. He also noted HIFU’s role in salvage therapy for patients whose primary radiation therapy has failed.

Market dynamics and Medicare utilization trends

Rhodes argued that patient preferences are shifting toward treatment options that aim to preserve quality of life while providing adequate cancer control. He contrasted active surveillance, which he said preserves quality of life but has low efficacy as it is not a treatment, with surgery and radiation, which he characterized as high efficacy but lower quality-of-life preservation.

He also pointed to Medicare claims data from CMS, stating that HIFU procedures showed “exponential” growth on a compounded annual basis from calendar years 2022 through 2024, while radical prostatectomy was flat and radiation therapy, brachytherapy, and cryoablation were declining.

Focal One platform updates and clinical evidence

Rhodes said the company launched Focal One i in late April 2025, describing it as a major platform improvement. He said enhancements include broader fusion capabilities supporting multiple imaging inputs (including MRI and PSMA PET), integration with certain AI and biopsy mapping tools, streamlined workflows, embedded video recording and streaming for proctoring and telecollaboration, and readiness for endometriosis treatment in markets where the company has approval or a CE mark.

On clinical evidence, Rhodes highlighted the “trifecta” outcomes commonly used in prostate cancer—cancer control, urinary continence, and sexual function—and said there are more than 1,000 peer-reviewed publications supporting HIFU’s use in prostate cancer.

• HIFI study: Rhodes cited the HIFI study, published in December 2024, describing it as the largest prospective comparative study of its kind. He said it included 3,328 patients across 46 centers and 80 physicians, with about 90% of HIFU patients treated using Focal One and the remainder treated with EDAP’s Ablatherm platform. He said the study showed comparable cancer control versus surgery and superior functional outcomes for HIFU, including urinary continence and erectile function.
• FARP randomized controlled trial: Rhodes discussed the FARP study (focal ablation versus radical prostatectomy), presented at the AUA meeting last year. He said it was a non-inferiority trial with 213 patients and showed comparable cancer control at three years versus surgery, with superior functional outcomes following focal ablation. He also noted that 25% of patients randomized to surgery refused surgery and preferred HIFU therapy. Rhodes said the results have not yet been published and are expected to be submitted and “ideally published” in 2026.
• Comparison to radiation: Rhodes referenced an October publication in the International Urology and Nephrology Journal stating that HIFU demonstrated equivalent 10-year survival compared with external beam radiation therapy, and he cited mortality figures presented on the slide (9.2% for HIFU versus 16.7% for external beam radiation at 10 years, and cancer-specific mortality of 5.4% versus 9.2%).

Reimbursement and expanding installed base

On reimbursement, Rhodes said hospital reimbursement for HIFU is categorized as APC6 and that a new payment mechanism implemented in January increased payment by another 4.3% for HIFU under CPT code 55880. He added that the Medicare payment is approaching what surgeons are paid for surgery, while commercial insurance reimbursement could be “somewhere between 1.5x–2x.” For physician reimbursement, he said CPT 55880 carries a work RVU of 17.29 and is “nearly $200” less than surgeon payment for surgery.

EDAP also described growing adoption across U.S. hospitals. Rhodes said the company had 87 Focal One systems installed as of Dec. 31, 2025, split between 42 academic and 45 community hospitals. He cited placements at institutions including Mayo Clinic, Cleveland Clinic, MD Anderson, and Memorial Sloan Kettering, and said every University of California teaching hospital has incorporated Focal One. He also cited presence in Kaiser and HCA hospitals and said 10 hospital systems have purchased a second Focal One system.

In Europe, Rhodes said EDAP had 41 Focal One systems and 254 clinical treatment sites, including both fixed and mobile clinical sites, and referenced momentum following the European Association of Urology meeting in London.

Pipeline opportunities in BPH and endometriosis

Beyond prostate cancer, Rhodes highlighted benign prostatic hyperplasia (BPH) as another large opportunity. He cited 94 million global cases (based on 2019 data), 15 million U.S. men affected by BPH or lower urinary tract symptoms, and 600,000 new diagnoses annually among U.S. men aged 65 or older. He said EDAP has been involved in feasibility and phase 1–2 clinical studies and has an IRB-approved U.S. academic site expected to treat patients in the first half of the year, along with two studies outside the U.S.

Rhodes also discussed endometriosis, focusing on deep infiltrating endometriosis. He said EDAP received a CE mark in March of last year for Focal One in treating deep infiltrating endometriosis and has begun a limited launch in Europe with training underway. He described current stage 4 treatment options as invasive surgical procedures such as rectal or partial rectal resection or serosal stripping, and said EDAP believes a frontline therapy could reduce morbidity for some patients. He said the company expects further progress through calendar year 2026.

In Q&A, Kalia asked how EDAP targets physicians and sites given the prevalence of da Vinci prostatectomy. Rhodes said EDAP looks at factors such as biopsy data and the size of active surveillance programs, noting some centers monitor 1,000 to 2,000 men. He said 40% to 50% of men may show disease progression by five years and argued focal therapy can provide an alternative to radical treatments for many favorable intermediate-risk and lower-grade cancers. He added that focal therapy is “one of the hottest” topics at scientific meetings and said the company’s approach coexists with surgery, which remains necessary for some patients.

Asked about Aquablation in BPH and a trial in prostate cancer, Rhodes said he understood the prostate cancer work may be whole-gland treatment and referenced published reports of bleeding or delayed bleeding in BPH, adding that he would be interested to see outcomes. He said EDAP remains anchored in prostate cancer while advancing BPH studies, and noted that urinary symptom scores commonly improve in prostate cancer patients treated with HIFU—something he attributed to tissue ablation relieving pressure on the prostatic urethra.

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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