Welcome to our dedicated page for Edap Tms news (Ticker: EDAP), a resource for investors and traders seeking the latest updates and insights on Edap Tms stock.
EDAP TMS SA (NASDAQ: EDAP) delivers innovative therapeutic ultrasound solutions for urological care through its HIFU and lithotripsy technologies. This news hub provides investors and medical professionals with essential updates on the company's advancements in robotic medical devices, regulatory milestones, and global market strategies.
Access real-time announcements including clinical trial results, product approvals, financial disclosures, and strategic partnerships. Our curated collection features press releases about EDAP's three operational divisions: HIFU tumor ablation systems, ESWL stone treatment devices, and distribution of complementary medical technologies.
Stay informed about developments in minimally-invasive treatment solutions that demonstrate EDAP's commitment to advancing urological care. The resource is regularly updated with material events affecting the company's position in the competitive medical devices sector.
Bookmark this page for streamlined access to verified information about EDAP's technological innovations, international expansion efforts, and research collaborations with leading medical institutions.
EDAP TMS SA (Nasdaq: EDAP) announced the publication of the HIFI study results in European Urology, comparing Focal One® Robotic HIFU to radical prostatectomy (RP) for localized prostate cancer treatment. The landmark study, involving 3,328 patients across 46 centers, demonstrated that Focal One Robotic HIFU is non-inferior to surgery for Salvage Treatment-free Survival at 30 months.
Key findings show that the HIFU arm achieved 90% adjusted STFS compared to 86% in the RP arm. HIFU patients experienced significantly better outcomes in urinary continence (29% vs 44% deterioration) and erectile function. These superior functional results were achieved despite HIFU patients being approximately 9.6 years older than RP patients (median age 74.7 vs 65.1 years).
EDAP TMS (Nasdaq: EDAP), a leader in robotic energy-based therapies, announced its participation in the Piper Sandler 36th Annual Healthcare Conference in New York City. CEO Ryan Rhodes will engage in a fireside discussion and conduct one-on-one investor meetings during the event, scheduled for December 3-5, 2024. The fireside chat is set for Tuesday, December 3rd, from 4:00-4:25 PM EST. Both live and archived webcasts will be available through the company's investor relations website section.
EDAP TMS SA announced a scientific presentation demonstrating the technical feasibility of their Focal One® Robotic HIFU technology to perform non-thermal histotripsy energy delivery. The study, presented at the 187th Acoustical Society of America meeting, showed the system's capability to generate histotripsy lesions in biological tissues ex vivo. Histotripsy is a non-ionizing, non-thermal, and noninvasive technique for tissue ablation that uses microsecond ultrasound pulses for mechanical tissue destruction. The company views this as a significant technical milestone alongside their development of real-time elastography for ablation treatment confirmation.
EDAP TMS SA presented clinical data comparing Focal One HIFU versus surgery for treating deep infiltrating endometriosis at the 2024 AAGL Global Congress. The retrospective multicenter study analyzed 120 patients across two cohorts: 60 patients treated with HIFU and 60 with surgery. Results showed that HIFU therapy demonstrated significant advantages over surgical intervention, including fewer moderate and severe post-operative complications, shorter operating time, and reduced hospital stay. The company's ongoing Phase 3 trial shows promising progress, with over 85% of Sham treatment patients opting for HIFU therapy after symptoms returned.
EDAP TMS reported Q3 2024 worldwide revenue of EUR 13.1 million, up 11.6% year-over-year. HIFU revenue grew 48.2% to EUR 4.5 million, with 34% growth in U.S. Focal One procedures. The company sold three Focal One systems in Q3. Gross profit reached EUR 5.2 million with a 39.4% margin. Operating loss was EUR 5.8 million, and net loss was EUR 6.4 million. Notable developments include a new AI collaboration with Avenda Health, positive progress in BPH and endometriosis clinical trials, and CMS's 5.4% increase in Medicare Hospital Outpatient Focal One HIFU procedure payment for 2025.
EDAP TMS SA (Nasdaq: EDAP), a leader in robotic energy-based therapies, has announced its participation in the upcoming 2024 Jefferies London Healthcare Conference. CEO Ryan Rhodes will present and conduct one-on-one investor meetings during the event, scheduled for November 19-21, 2024. The presentation is set for Tuesday, November 19, at 8:30-8:55 AM GMT at The Waldorf Hilton London. Both live and archived webcasts of the presentation will be available through the company's website's Investor section.
EDAP TMS SA (Nasdaq: EDAP), a leader in robotic energy-based therapies, has scheduled its third quarter 2024 financial results release for November 7, 2024, before market open. The company will host a conference call and webcast at 8:30 AM EDT on the same day. CEO Ryan Rhodes, CFO Ken Mobeck, and CAO François Dietsch will lead the discussion. The conference call will be accessible via domestic (1-800-445-7795) and international (1-785-424-1699) dial-in numbers using passcode EDAP.
EDAP TMS SA (Nasdaq: EDAP) has announced the initiation of a Phase I/II study evaluating its Focal One® robotic high-intensity focused ultrasound (HIFU) technology for treating benign prostatic hyperplasia (BPH). The first patients have been treated in this study, which aims to explore a less invasive treatment option for BPH.
The study is designed in two parts: Part 1 will define optimal treatment parameters at two leading academic centers in France, while Part 2 will validate safety and efficacy across multiple centers. Dr. Harry Toledano, Head of Urology at Martigues Hospital, expressed enthusiasm about the potential of HIFU to improve BPH symptoms with minimal side effects.
EDAP's CEO, Ryan Rhodes, highlighted the significant need for less invasive BPH treatments and sees this as a logical expansion of their technology beyond prostate cancer applications. The company plans to initiate a BPH clinical study in the United States next year based on this foundational research.
EDAP TMS SA (Nasdaq: EDAP) and Avenda Health have launched the world's first AI-assisted Focal One® Robotic HIFU procedures for prostate cancer treatment. The collaboration integrates Avenda's FDA-cleared Unfold AI® technology with EDAP's Focal One robotic HIFU platform. Unfold AI creates 3D patient-specific cancer maps, enabling more precise tumor targeting and healthy tissue preservation.
The first AI-assisted procedures were successfully performed at UCLA School of Medicine. This integration aims to provide more tailored, patient-specific HIFU ablation for prostate cancer patients. The companies will present simulated procedures at the 2024 Joint Meeting of the Focal Therapy Society & Society of Urologic Robotic Surgeons in Washington, DC.
EDAP TMS SA (Nasdaq: EDAP), a leader in robotic energy-based therapies, announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference. The event is scheduled for September 9-11, 2024, in New York City. Ryan Rhodes, EDAP's CEO, will engage in a fireside chat and conduct one-on-one investor meetings.
Key details:
- Date: Tuesday, September 10th, 2024
- Time: 3:00-3:30 PM ET
- Location: Lotte New York Palace Hotel
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