EDAP: 8-K · other
EDAP TMS SA (trading as FocalTherics, ticker FOCL) hosted an Investor Day on June 1, 2026, announcing a strategic transformation into a pure-play robotic focal therapy company. The firm rebranded to FocalTherics and moved its non-core Extracorporeal Shock Wave Lithotripsy (ESWL) and Distribution businesses to discontinued operations as of Q2 2026 to focus exclusively on its High Intensity Focused Ultrasound (HIFU) platform. The company provided updated financial guidance, projecting HIFU revenue of $50-54 million for CY26, representing approximately 40% year-over-year growth from CY25’s $37 million. Management outlined a long-term target model aiming for ~60% gross margins and operating income breakeven by CY28, supported by an installed base of 175+ systems globally and 53% procedure volume growth in Q1 2026. FocalTherics highlighted clinical expansion into Benign Prostatic Hyperplasia (BPH) and Deep Infiltrating Endometriosis (DIE), citing a total addressable market exceeding $10 billion. The presentation emphasized favorable reimbursement dynamics, with Medicare paying $10,860 per HIFU procedure, and showcased technological innovations including AI-driven treatment planning and telecollaboration capabilities via FocalConnect.
Edap Tms Unveils FocalTherics Pivot, Targets 40% Growth on HIFU Expansion
EDAP Announces Corporate Name Change to FocalTherics™ to Reflect Exclusive Focus on High-Growth Robotic Focal Therapy
EDAP TMS S.A. announced it will change its corporate name to FocalTherics and its Nasdaq ticker symbol from EDAP to FOCL, effective June 1, 2026. The rebranding reflects the company's exclusive strategic focus on robotic focal therapy, specifically its flagship Focal One platform, while distancing itself from legacy businesses. The company intends to classify its Extracorporeal Shock Wave Lithotripsy (ESWL) and Distribution operating segments as discontinued operations beginning with Q2 2026 financial results. An Investor Day will be held on June 1, 2026, to outline the long-term strategy under the new identity.
EDAP | Focal One to Present at Jefferies 2026 Global Healthcare Conference
EDAP TMS SA announced that CEO Ryan Rhodes will present at the Jefferies 2026 Global Healthcare Conference on June 4, 2026. The presentation is scheduled for 2:00-2:30 PM ET in New York, followed by 1x1 investor meetings hosted by Rhodes and CFO Ken Mobeck. A live and archived webcast of the presentation will be available via the company's investor relations website.
Telix Announces Collaborations to Explore PSMA-PET Imaging in Emerging Prostate Cancer Treatment Approaches
EDAP TMS has entered into a letter of intent with Telix Pharmaceuticals to explore integrating Telix’s PSMA-PET imaging agents with EDAP’s Focal One robotic HIFU system for prostate cancer treatment. The collaboration aims to optimize treatment efficacy and minimize side effects by using imaging for patient selection, treatment planning, and post-treatment monitoring. EDAP also joined Profound Medical in similar collaborations with Telix, signaling a broader industry shift toward image-guided, personalized focal therapy workflows.
EDAP: DEF 14A · proxy statement
In 2025, EDAP TMS S.A. achieved significant milestones, including the introduction of Focal One i, a next-generation HIFU platform. This platform enhances clinical capabilities and integrates seamlessly with advanced imaging technologies, positioning the company for broader adoption in prostate cancer care. The company also reported robust year-over-year growth in its HIFU business, driven by increased system placements, rising procedure volumes, and expanded utilization, particularly in the United States. The 2026 Annual General Meeting of Shareholders will be held on June 26, 2026, at 3:00 PM local time in Vaulx-en-Velin, France. Shareholders will vote on several resolutions, including the renewal of director terms, ratification of the temporary appointment of David Horn, and approval of the statutory and consolidated financial statements for the fiscal year ended December 31, 2025. The Board of Directors is requesting authority to increase the share capital through various means, including public offerings and private placements, with and without preferential subscription rights. This authority is necessary to finance the company's development and strategic initiatives, such as mergers, spin-offs, and contributions of assets. The maximum aggregate nominal amount of share capital increases is 2,600,000 euros, and the nominal amount of debt securities issuances is 75,000,000 euros. The company has also entered into a Warrant Agreement with the European Investment Bank (EIB), under which it has committed to issue warrants to EIB upon the release of financing tranches. As of April 1, 2026, the company has issued 1,116,244 BSA Tranche B Warrants, with a total subscription price of 145,111.73 euros and a strike price of 3.23 euros per ordinary share.
EDAP | Focal One and Telix Announce Collaboration Focused on Robotic HIFU and Theranostics in Prostate Cancer
EDAP TMS S.A. and Telix Pharmaceuticals Limited have entered into a letter of intent to explore joint clinical research and physician education focused on the combination of EDAP’s Focal One Robotic HIFU and Telix’s PSMA PET imaging products for prostate cancer management. The initial focus will be on integrating PSMA PET diagnostic imaging into the Focal One HIFU treatment workflow to optimize treatment planning, deliver precise therapy, and monitor patient responses. Both companies are leaders in their respective fields, with EDAP’s Focal One being a recognized platform for prostate focal therapy and Telix’s PSMA PET imaging products having the potential to enhance treatment decisions. The collaboration is expected to accelerate the development and standardization of treatment strategies, but no financial commitments have been made and there is no assurance that specific initiatives will result from this initial agreement.
EDAP | Focal One to Host Investor Day on June 1, 2026
EDAP TMS SA, the global leader in robotic energy-based therapies, will host an Investor Day on June 1, 2026, at 8:00 am ET. The event will feature presentations from the Company’s Executive Leadership Team and a prominent urologic surgeon, covering growth strategy, long-term financial targets, and expanding therapeutic indications. Participants can join via the provided registration link, and a replay of the webcast will be available on the company’s website.
EDAP TMS S.A. (EDAP) Q1 2026 Earnings Call Transcript
EDAP Reports Strong Financial Results with Record First Quarter HIFU Revenue
EDAP reported Q1 2026 revenue of $17.8 million, driven by a 78% year-over-year surge in HIFU revenue to a record $11.6 million. Gross margin improved to 45.7% from 42.0%, reflecting a favorable product mix shift towards high-margin HIFU capital sales and disposables. The company reiterated full-year guidance for HIFU revenue of $50-54 million, supported by landmark HIFI-2 study results published in European Urology Oncology.
EDAP TMS Strengthens Market Position with Landmark HIFI-2 Data Supporting Focal One® Robotic HIFU in Radiorecurrent Prostate Cancer
EDAP TMS announced the publication of the HIFI-2 study in European Urology Oncology, which is the largest prospective dataset to date evaluating salvage HIFU using Focal One for radiorecurrent prostate cancer. The study of 531 patients showed a 71% androgen deprivation therapy-free survival rate at 30 months, rising to 84% in favorable patient subgroups, with low rates of severe complications. CEO Ryan Rhodes noted that the results reinforce the clinical value of Focal One and strengthen the company's leadership position as NCCN guidelines and Medicare coverage already support HIFU in this setting.
EDAP to Announce First Quarter 2026 Financial Results on May 7, 2026
