Research analysts who have asked questions during EDAP TMS earnings calls.
MS
Michael Sarcone
Jefferies
8 questions for EDAP
Also covers: ALC, ALGN, AXGN +12 more
XL
Xun Lee
H.C. Wainwright & Co., LLC
5 questions for EDAP
Also covers: ATEC, CRVS, CTSO +2 more
SR
Swayampakula Ramakanth
H.C. Wainwright & Co.
3 questions for EDAP
Also covers: ABSI, BSEM, CGEN +24 more
Joseph Downing
Piper Sandler
2 questions for EDAP
Also covers: LUNG
Jason Bednar
Piper Sandler Companies
1 question for EDAP
Also covers: ALGN, COO, GEHC +15 more
Recent press releases and 8-K filings for EDAP.
EDAP Announces Preliminary Q4 and Full Year 2025 Results and Issues 2026 Guidance
EDAP
Earnings
Guidance Update
Revenue Acceleration/Inflection
- EDAP announced preliminary worldwide HIFU revenue for Q4 2025 is expected to be between $12.9 million and $13.3 million, and for the full year 2025, between $36.7 million and $37.2 million, marking the highest quarterly and annual HIFU revenue in the company's history.
- Preliminary non-core revenue for Q4 2025 is expected to range from $7.9 million to $8.3 million, with the full year 2025 non-core revenue expected between $32.7 million and $33.1 million.
- For 2026, the company issued guidance expecting core HIFU business revenue in the range of $50.0 million to $54.0 million and combined non-core business revenue between $22.0 million and $26.0 million.
- Operational highlights for Q4 2025 include a record 15 Focal One system placements and an approximate 28% year-over-year increase in U.S. Focal One HIFU procedures.
Jan 12, 2026, 12:30 PM
EDAP Discusses Capital Environment, HIFU Growth Strategy, and Margin Expansion
EDAP
Revenue Acceleration/Inflection
New Projects/Investments
Guidance Update
- EDAP's CEO reported 167% growth in Focal One capital sales last quarter, emphasizing the system's strategic value for hospitals in treating prostate cancer.
- The company is focusing on its core HIFU business, projecting HIFU revenue growth of 26-34% for the year, while non-core business is expected to decline by 25-30%. This strategy is enhancing gross margins, which rose from 39% to 42% in Q3 2024, with HIFU margins in the high forties.
- Financial tailwinds include a U.S. average selling price of approximately $650,000 for Focal One and an anticipated 5% increase in CMS Medicare reimbursement for Focal therapy starting January 1.
- EDAP launched the Focal One Eye platform and received 510(k) clearance for platform improvements, which are expected to drive further gross margin improvements into 2026.
- The company is expanding HIFU indications, with a U.S. feasibility study for BPH underway and the first patients anticipated in Q1 2026.
Dec 2, 2025, 3:30 PM
EDAP Discusses Capital Environment, HIFU Growth, and Margin Expansion
EDAP
Revenue Acceleration/Inflection
Product Launch
New Projects/Investments
- EDAP's Focal One capital sales grew 167% last quarter, with the company navigating a strategic capital environment where hospitals prioritize investments with strong clinical value and economic rewards.
- The company anticipates a 5% increase in CMS Medicare reimbursement for Focal One procedures starting January 1 (referring to January 1, 2026), supporting the economic argument for hospital investment.
- EDAP is strategically focusing on its core HIFU business, which has gross margins trending in the high forties, contributing to an overall gross margin increase to 42% in Q3 2024 from 39%.
- The launch of the Focal One Eye platform, with a U.S. average selling price of approximately $650,000, and a recent 510(k) clearance are expected to drive significant margin improvements in 2026 through reduced material costs and increased ASP.
- EDAP is actively pursuing a Benign Prostatic Hyperplasia (BPH) indication, with patient enrollment underway for a feasibility study in New York and a combined phase one/two study in Europe, with U.S. patient treatment expected in Q1 2026.
Dec 2, 2025, 3:30 PM
EDAP TMS Discusses Capital Environment, Growth, and Strategic Focus
EDAP
Guidance Update
Product Launch
Revenue Acceleration/Inflection
- EDAP TMS reported 167% growth in Focal One capital sales last quarter, with management highlighting that hospitals view the investment as strategic due to its clinical value and economic reward.
- CMS Medicare reimbursement for Focal One procedures is expected to increase by approximately 5% starting January 1.
- The company is strategically focusing on its core HIFU business, which is anticipated to drive incremental revenue and improve gross margins, reported at 42% in Q3 2024, up from 39%. The new Focal One Eye platform, launched in April, has an average selling price of approximately $650,000 in the U.S. and is expected to further enhance margins in 2026.
- EDAP TMS confirmed it is comfortable with its full-year guidance, projecting HIFU revenue growth of 26%-34% and a 25-30% decline in its non-core business.
- Progress is being made on the BPH indication, with patient enrollment for an initial feasibility study in New York underway and treatment expected to begin in Q1 2026.
Dec 2, 2025, 3:30 PM
EDAP TMS Receives FDA 510(k) Clearance for Focal One HIFU System Enhancements
EDAP
Product Launch
New Projects/Investments
- EDAP TMS S.A. announced on November 20, 2025, that it received FDA 510(k) clearance for new ultrasound imaging and workflow enhancements to its Focal One High Intensity Focused Ultrasound (HIFU) system.
- The clearance introduces advanced ultrasound imaging, streamlined treatment planning, and an optimized user-interface to the Focal One i, which was launched earlier this year.
- The new imaging engine provides real-time visualization and supports the potential development of AI-driven algorithms designed to assist surgeons with tissue ablation visualization and treatment evaluation.
- CEO Ryan Rhodes stated that this achievement enhances the capabilities of the new Focal One i and reinforces Focal One's global leadership in focal therapy.
Nov 20, 2025, 12:33 PM
EDAP Highlights Focal One Growth, New Indications, and Margin Improvement at Jefferies Conference
EDAP
Product Launch
Revenue Acceleration/Inflection
New Projects/Investments
- EDAP's Focal One HIFU platform for prostate cancer demonstrated 15% quarter-over-quarter procedure growth from Q3 2024 to Q3 2025, with a 67% CAGR for Focal One procedures over a period, and has nearly 80 systems placed globally.
- The company is expanding its market opportunity with new indications, including a limited launch in Europe for stage four deep infiltrating endometriosis (CE mark approved) and initiating a U.S. study for Benign Prostatic Hyperplasia (BPH) at Mount Sinai, with first patient treatments expected by year-end.
- Recent clinical studies, such as the HIFY study (3,328 patients) and the FARP randomized control trial (213 patients), support Focal One's efficacy, demonstrating adequate oncologic control and superior functional outcomes compared to traditional treatments.
- EDAP is strategically focusing on its higher-margin HIFU business, which contributed to an increase in gross margins from 39.4% to 43% in Q3, with a stated goal to achieve profitability in the coming years.
Nov 18, 2025, 4:30 PM
EDAP Launches Focal One Eye Platform and Reports Q3 2025 Procedure Growth
EDAP
Product Launch
Revenue Acceleration/Inflection
New Projects/Investments
- EDAP launched its Focal One Eye platform in May 2025 and is expanding into new indications, including Benign Prostatic Hyperplasia (BPH) with a U.S. study beginning by year-end 2025, and stage four deep infiltrating endometriosis with a limited European launch after CE mark approval.
- The company achieved record HIFU revenue last quarter and reported Focal One procedures growing 15% quarter-over-quarter in Q3 2025 compared to Q3 2024, with nearly 80 systems placed globally and established reimbursement.
- EDAP's strategic focus on its higher-margin HIFU business resulted in gross margins increasing from 39.4% to 43% in Q3 2025, with a stated goal to achieve overall profitability in the coming years.
Nov 18, 2025, 4:30 PM
EDAP Discusses Focal One Growth, New Indications, and Financial Strategy at Jefferies Conference
EDAP
Product Launch
New Projects/Investments
Revenue Acceleration/Inflection
- EDAP launched its Focal One i platform in May 2025, an advanced robotic HIFU system for prostate tissue ablation, and has nearly 80 systems placed globally in leading cancer hospitals.
- The company reported strong growth in Focal One procedures, with a 15% quarter-over-quarter increase in Q3 2025, driven by navigating payer issues and effective program launches.
- EDAP is expanding into new indications, with a Benign Prostatic Hyperplasia (BPH) study commencing at Mount Sinai Hospital by the end of 2025 and a limited European launch for stage four deep infiltrating endometriosis.
- Financially, EDAP is focusing on its higher-margin HIFU business, leading to an increase in gross margins from 39.4% to 43% in Q3 2025, with a strategic goal to achieve profitability.
Nov 18, 2025, 4:30 PM
EDAP TMS S.A. Reports Q3 2025 Financial Results and Operational Highlights
EDAP
Earnings
New Projects/Investments
Revenue Acceleration/Inflection
- EDAP TMS S.A. reported Q3 2025 revenue of $16.1 million, an increase from $14.4 million in Q3 2024, driven by a 57% growth in HIFU revenue to $7.7 million.
- For the nine months ended September 30, 2025, total revenue reached $48.8 million, with a net loss of $19.8 million and ($0.53) earnings per share.
- The company's Focal One Robotic HIFU technology saw its U.S. install base grow to 76 systems as of September 30, 2025, supported by strong clinical evidence for prostate cancer treatment and favorable reimbursement with APC Level 6 maintained by CMS in 2025.
- EDAP TMS S.A. is expanding into new indications, having received CE mark certification on March 25, 2025, for the treatment of posterior deep endometriosis infiltrating the rectum.
Nov 18, 2025, 11:05 AM
EDAP Reports Record Q3 2025 Revenue Driven by HIFU Business Growth
EDAP
Earnings
Guidance Update
Revenue Acceleration/Inflection
- EDAP reported record global revenues of $16.1 million for Q3 2025, with its core HIFU business revenue increasing 57% year-over-year to $7.7 million.
- The company achieved 8 Focal One placements in Q3 2025, representing 167% growth compared to the same period last year, and US Focal One procedures grew more than 15% year-over-year.
- Net loss for the third quarter of 2025 was EUR 5 million, or EUR 0.13 per share, an improvement from the EUR 6.4 million net loss or EUR 0.17 per share in Q3 2024.
- EDAP is maintaining its 2025 financial guidance, projecting core HIFU business revenue growth between 26% and 34% year-over-year.
- The first tranche of EUR 11 million (approximately $13 million) from the European Investment Bank credit facility was received and will be reflected in Q4 and full-year 2025 financial statements.
Nov 6, 2025, 1:30 PM
Quarterly earnings call transcripts for EDAP TMS.
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