EDAP TMS SA

EDAP TMS SA held its 2026 Annual General Meeting where shareholders approved several key resolutions. These included amendments to the company's bylaws, the renewal and ratification of multiple director terms, and the approval of related-person agreements. Additionally, shareholders approved the statutory and consolidated financial statements for fiscal year 2025, renewed the statutory auditor, and provided non-binding advisory approval for named executive officer compensation, recommending annual votes on the matter.

EDAP TMS SA, operating as FocalTherics, presented its strategic transformation into a high-growth, pure-play robotic focal therapy company at its Investor Day on June 1, 2026. The company is accelerating its HIFU business, projecting significant revenue growth and moving non-core segments to discontinued operations. Key initiatives include expanding the Focal One platform to new indications like BPH and Endometriosis, supported by favorable reimbursement and clinical evidence. EDAP TMS SA reiterated its financial guidance, emphasizing a pathway to profitability driven by its focused HIFU strategy.

EDAP TMS S.A. announced it will begin operating under the new corporate name "FocalTherics" and trade under the new Nasdaq ticker symbol "FOCL" starting June 1, 2026. This rebranding reflects the company's exclusive focus on high-growth robotic focal therapy. Additionally, EDAP intends to classify its legacy Extracorporeal Shock Wave Lithotripsy (ESWL) and Distribution operating segments as discontinued operations, beginning with its second quarter 2026 financial results. The company will discuss its new identity and strategy at an Investor Day on June 1, 2026.

EDAP TMS SA announced that its Chief Executive Officer, Ryan Rhodes, is scheduled to present at the Jefferies 2026 Global Healthcare Conference in New York. He will be joined by Chief Financial Officer Ken Mobeck to host 1x1 investor meetings. The presentation is set for Thursday, June 4, 2026, from 2:00-2:30 PM ET, with a live and archived webcast accessible via the company's investor relations section.

EDAP TMS SA reported a pivotal 2025, achieving record revenue in its HIFU business, driven by increased system placements and procedure volumes, particularly in the U.S. The company introduced Focal One i, an advanced HIFU platform, and secured a significant CE Mark in March 2025 for the treatment of posterior deep infiltrating endometriosis, expanding its indications beyond prostate cancer. The filing also details the agenda for the 2026 Annual General Meeting on June 26, 2026, including proposals for director renewals, financial statement approvals for 2025, and various capital increase delegations.

EDAP TMS S.A. announced a letter of intent with Telix Pharmaceuticals Limited to explore joint clinical research and physician education. The collaboration will focus on integrating EDAP's Focal One Robotic HIFU with Telix's PSMA PET imaging products to optimize prostate cancer treatment planning, delivery, and monitoring. This initiative aims to advance personalized focal therapy, potentially improving patient outcomes in both primary and salvage treatment settings. While the parties may enter into more definitive agreements, no financial commitments have been made, and no material financial impact on EDAP is expected at this time.

EDAP TMS SA announced it will host an Investor Day for analysts and investors on Monday, June 1, 2026, from 8:00-10:00 am ET. The event will feature presentations from the Company's Executive Leadership Team and a prominent urologic surgeon. Key topics will include the Company's business plans, strategic path forward, growth strategy, long-term financial targets, expanding therapeutic indications, and focal therapy leadership through innovation.

EDAP TMS SA reported a 24.8% increase in total revenues to $17.8 million for the first quarter of 2026, driven by growth across its HIFU, ESWL, and Distribution segments. Despite the revenue growth and a 35.9% rise in gross profit, the company's net loss widened to $(9.1) million, resulting in a diluted loss per share of $(0.24). Cash and cash equivalents decreased to $15.0 million, but the company subsequently secured additional liquidity by drawing €12.0 million from its EIB credit facility in April 2026.

EDAP TMS SA reported strong financial results for the first quarter of 2026, with record HIFU revenue of $11.6 million, representing a 78% year-over-year increase. U.S. Focal One procedure volumes grew 53%, and Focal One system shipments increased 83%. Total worldwide revenue reached $17.8 million, up from $14.3 million in Q1 2025, with gross profit margin improving to 45.7%. The company also highlighted positive results from the landmark HIFI-2 study. However, operating loss increased to $7.4 million and net loss to $9.1 million, or ($0.24) per share. EDAP reiterated its 2026 HIFU revenue guidance of $50.0 million to $54.0 million.

EDAP TMS SA reported strong first-quarter 2026 financial results, driven by record High-Intensity Focused Ultrasound (HIFU) revenue of $11.6 million, a 78% increase year-over-year. The company saw significant growth in U.S. Focal One procedures, up 53%, and an 83% increase in Focal One system shipments. Total revenue for the quarter reached $17.8 million, with an improved gross profit margin of 45.7%. EDAP also reiterated its 2026 financial guidance for both its core HIFU and non-core businesses.