Edap Tms Unveils FocalTherics Pivot, Targets 40% Growth on HIFU Expansion

Edap Tms (NASDAQ:EDAP) used its 2026 FocalTherics Investor Day to outline its shift toward becoming a “high-growth, pure-play robotic focal therapy company,” with management emphasizing the company’s Focal One robotic high-intensity focused ultrasound, or HIFU, platform for prostate cancer and future indications.

Chief Executive Officer Ryan Rhodes said the newly announced FocalTherics identity combines “focal therapy” and “therapeutics” and reflects a strategic focus on robotic focal therapy. Rhodes said the company’s recent growth has been driven primarily by its HIFU business, while non-core businesses, including ESWL and distribution, have declined.

Rhodes said the company’s three strategic pillars are scaling commercial execution in prostate cancer, expanding the Focal One platform into new indications, and advancing technological innovation in HIFU and beyond. He described Focal One as a non-invasive procedure that uses imaging, focused ultrasound and robotic energy delivery to provide organ-sparing and function-preserving treatment.

Management Highlights Prostate Cancer Market Opportunity

Rhodes said prostate cancer remains the company’s initial major market, citing nearly 1.4 million newly diagnosed cases globally each year and about 330,000 in the United States. He said the market is shifting from radical treatments, such as surgery and radiation, toward focal approaches that aim to preserve quality of life while maintaining cancer control.

Rhodes said Focal One Robotic HIFU is intended to bridge the gap between active surveillance and radical treatment, particularly for low- and intermediate-risk prostate cancer patients. He described a potential $4 billion total addressable market in prostate cancer and said focal therapy could eventually become larger than surgery or radiation as standalone categories.

The company said its Focal One installed base is 175 and growing, with adoption across academic and community hospitals. Rhodes said Focal One is in seven of the 10 U.S. News & World Report-ranked hospitals, 66% of Society of Urologic Oncology fellowship programs and nearly 60% of National Comprehensive Cancer Network participating hospitals. He also said the company has a qualified pipeline involving about 300 U.S. hospitals.

Rhodes said procedures across 91 accounts grew 53% year over year on a quarterly basis. He said 70% of procedures performed year-to-date in 2026 required no clinical application support, indicating that sites are becoming more independent as programs mature.

Clinical Evidence and Physician Perspective

Rhodes highlighted several clinical studies supporting Focal One HIFU, including the HIFI study comparing HIFU with radical prostatectomy, the HIFI-2 salvage study in post-radiation patients, and other studies comparing HIFU with radiation, surgery or active surveillance. He said the HIFI study involved 3,328 patients across 46 centers and 80 urologists, met its primary endpoint of cancer control and showed advantages in urinary continence and erectile function preservation.

Dr. Behfar Ehdaie, a urologic surgeon at Memorial Sloan Kettering Cancer Center, said focal therapy developed in response to the need for prostate cancer treatments that reduce quality-of-life burdens. Ehdaie said many patients do not benefit from radical treatments and that MRI-based diagnostics have made it possible to identify and target the most clinically important lesions.

Ehdaie said Memorial Sloan Kettering introduced its Focal One program in 2023 and described the system as efficient and reproducible. He said unpublished data from the center showed that recurrence in the treated area was less than 10%, with 93% of patients having no cancer in the treated area based on MRI and biopsy. He also said more than 90% of patients maintained erectile function and that no patients in the center’s Focal One treatment history had incontinence.

Pipeline Includes BPH and Endometriosis

Rhodes said the company is pursuing benign prostatic hyperplasia, or BPH, as a new indication for the same Focal One platform. He cited more than 100 million men globally living with BPH conditions and said the company has two clinical efforts underway: patients treated under an IRB with Mount Sinai Hospital and in Latin America, and a Phase I/II study outside the United States in Europe. Rhodes said the company expects data toward the end of 2026 and a potential pivotal trial in early 2027.

Rhodes also discussed deep infiltrating endometriosis, saying 38 million women globally live with the condition. He said the company has completed three studies outside the United States and is in follow-up from a randomized controlled trial and Phase II study. FocalTherics has a CE mark launch underway in CE mark countries, and Rhodes said U.S. strategy will be finalized after data from pivotal studies is presented.

Technology Roadmap and Financial Targets

Steve Annen, executive vice president of marketing and product management, outlined investments in advanced imaging, artificial intelligence, remote connectivity and histotripsy. He said the company has integrated MRI, fusion biopsy data, AI-driven cancer mapping tools and PSMA PET imaging into Focal One. Annen also said the company signed a collaboration agreement with Telix Pharmaceuticals focused on PSMA PET-related physician education and clinical research.

Annen introduced Focal Connect, a remote telecollaboration initiative, and described a prior Cleveland Clinic event as the “world’s first transcontinental Focal One HIFU telecollaboration.” He said the company is continuing to work with Cleveland Clinic and Kaiser on the concept.

Chief Financial Officer Ken Mobeck said the company is at an “important inflection point,” with HIFU expected to represent more than 60% of company revenue in 2026 based on guidance. Mobeck said the company recently announced its intent to classify non-core businesses as discontinued operations and is maintaining HIFU revenue guidance of $50 million to $54 million for the year.

Mobeck said the company is targeting approximately 40% annual revenue growth, gross margins of 60%, operating income break-even by the end of 2028 and positive EBITDA during 2028. He said growth drivers include continued system placements, procedure volumes, international expansion and future contributions from new indications.

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.