Edap Tms Stock Price, News & Analysis

EDAP TMS SA (Nasdaq: EDAP) has appointed Joshua H. Levine to its Board of Directors. Levine brings extensive executive experience in the medical technology sector, with a proven track record of growing shareholder value through transformative business strategies.

Levine previously served as President, CEO, and Director of Accuray Incorporated (2012-2022), where he led a turnaround resulting in consistent top-line growth and positive operating profit. His prior roles include CEO positions at Immucor Inc. (acquired by TPG Capital for $2 billion) and Mentor (acquired by Johnson & Johnson for $1.2 billion).

The appointment comes as EDAP continues to expand its Focal One robotic HIFU platform, which is transforming prostate cancer treatment. The company aims to extend this technology to other therapeutic areas, including endometriosis and BPH.

EDAP TMS SA (NASDAQ: EDAP) has announced the successful treatment of the first patient in a phase I/II PULS Trial evaluating their proprietary High Intensity Focused Ultrasound (HIFU) technology for pancreatic tumors. The trial, sponsored by Centre Léon Bérard in Lyon, France, aims to assess both the tolerance and preliminary efficacy of intraoperative HIFU intervention on pancreatic lesions.

The first procedure was completed as planned, with the patient discharged without complications. This development represents a potential new treatment option for locally advanced pancreatic cancer patients, who currently have treatment options beyond chemotherapy and radiotherapy.

The trial's significance is highlighted by pancreatic cancer statistics: a five-year survival rate of just 11.5% across all stages (2012-2018 data), with 62,210 projected new cases and 49,830 projected deaths in the U.S. for 2022. Pancreatic cancer remains the third leading cause of cancer deaths, after lung and colorectal cancers.

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.