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EDAP TMS
EDAP TMS commercializes Focal One, a robotic HIFU platform for non-invasive prostate ablation, led by CEO Ryan Rhodes from its French base and U.S.
EDAP TMS
Founded in 1979, EDAP TMS began as a pioneer in extracorporeal shockwave lithotripsy, breaking up kidney stones without an incision — a mechanistic thread it would later weave into oncology. The company went public on the NASDAQ, and over four decades evolved from a French medical-device startup into a transatlantic commercial enterprise led since 2023 by Ryan Rhodes, a long-tenured medical-device operator who previously ran the urology division at Endo International. Its intellectual core remains in the Lyon suburbs, with a growing commercial footprint in Austin, Texas. EDAP TMS runs two primary lines: HIFU (high-intensity focused ultrasound) and ESWL (extracorporeal shockwave lithotripsy). The HIFU division is anchored by Focal One, a robotically guided ultrasound ablation platform cleared by the FDA for prostate tissue ablation. Unlike radical prostatectomy or whole-gland radiation, the system targets only the cancerous lesion, sparing surrounding nerves and tissue. EDAP also markets Ablatherm, an earlier HIFU iteration, predominantly in markets outside the United States. The lithotripsy portfolio includes Sonolith i-move, a mobile shockwave system for urinary stone fragmentation. Revenue is split across direct sales in the U.S. and distribution partnerships across Western Europe, East Asia, and Latin America. Confirmed therapeutic adjacencies include research-stage application of HIFU for pancreatic and rectal cancers, conducted through academic partnerships. With a market capitalization that has hovered in the small-cap range and no debt, EDAP TMS operates with a relatively lean cost structure. The company maintains direct subsidiaries in the United States, Japan, Korea, China, and Italy, and dispatches clinical application specialists to train urologists at newly adopting hospitals. In 2024, the company launched a leasing pop-up program in the U.S. aimed at lowering the capital-expenditure hurdle for community hospitals, while continuing to build peer-reviewed clinical evidence through multi-institutional registries tracking Focal One outcomes — a data strategy designed to influence urology guideline committees, the ultimate gatekeepers for procedure volume. EDAP TMS is distinct among surgical-robotics companies because its platform destroys tissue without any incision — no blade, no trocar, no radiation — using only focused sound waves guided by real-time ultrasound. Intuitive's da Vinci occupies the laparoscopic abdomen; EDAP's Focal One occupies the transrectal prostate pathway. That opens a competitive white space: non-invasive procedural urology, where barriers to entry are high and reimbursement codes are slowly maturing.
General information
Firm type
other
Year founded
1979
AUM
Undisclosed
Location
Region
Europe
Country
France
City
Vaulx-en-Velin
Corporate office
Vaulx-en-Velin, France
Additional offices
Austin, Texas, United States · Courtaboeuf, France · Seoul, South Korea · Tokyo, Japan · Shanghai, China · Milan, Italy
Principals
Ryan Rhodes
CEO
Sector focus
Frequently asked questions
Who leads EDAP TMS and what is their background?
Ryan Rhodes became CEO in 2023. He previously ran the urology division at Endo International and has spent his career commercializing specialty medical devices, particularly in men's health and pelvic health markets. Marc Oczachowski serves as Chairman, and François Dietsch is the long-serving Chief Financial Officer.
How does EDAP TMS's Focal One differ from Intuitive's da Vinci in urology?
Intuitive's da Vinci system is a laparoscopic surgical robot that assists surgeons in removing the entire prostate through small incisions. Focal One, by contrast, targets only the cancerous lesion using high-intensity focused ultrasound delivered transrectally. There are no incisions, no blood loss, and the procedure is typically outpatient. The two platforms compete for urologist practice share but are procedurally and technologically distinct.
What is EDAP TMS's regulatory status in the United States?
Focal One received FDA 510(k) clearance for prostate tissue ablation in 2018. The device is commercially available in the U.S. and actively placed in academic medical centers and large urology group practices. It does not yet have a specific CPT reimbursement code, which remains a key overhang for community-hospital adoption.
Does EDAP TMS generate recurring revenue or only capital equipment sales?
EDAP TMS generates a split between capital-equipment sales and disposable-probe revenue. Each Focal One procedure uses a single-use endorectal probe, creating a razor-and-blade revenue model. In markets with leasing contracts, the capital portion is spread over the contract term, increasing the proportion of recurring revenue.
What is the competitive landscape for focal therapy in prostate cancer?
EDAP TMS competes with AngioDynamics' NanoKnife (irreversible electroporation), Profound Medical's TULSA-PRO (transurethral ultrasound ablation), and emerging laser-ablation platforms. Focal One's principal clinical differentiator is real-time ultrasound guidance combined with a non-ionizing energy source, which avoids the MRI-dependency and radiation exposure of competing modalities.
Where is EDAP TMS's biggest commercial market?
The United States has become EDAP TMS's largest market by revenue since Focal One's FDA clearance. France and Japan remain significant legacy markets, particularly for lithotripsy. The company has also established direct subsidiaries in South Korea, China, and Italy, where regulatory approvals for HIFU are in place.
What clinical evidence supports Focal One's use?
The device was initially validated through European multicenter studies and received FDA clearance based on a pivotal U.S. clinical trial. Post-market, EDAP TMS funds the HIFU Focal Therapy Registry, a multi-institutional database tracking oncologic and functional outcomes. Published data shows five-year freedom from salvage therapy rates comparable to whole-gland treatments, with significantly lower rates of incontinence and erectile dysfunction.
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