Market Opportunity & Growth - The company is a global leader in therapeutic ultrasound for cancer and benign diseases, with a strong growth opportunity in urology and prostate cancer[4,6] - Prostate cancer is the most common cancer among men in the US, with 33 million American men living with it in 2025, and 313780 new cases diagnosed[14,15] - Globally, there are approximately 15 million new prostate cancer cases per year as of 2022, with Europe accounting for 473011 cases, Asia for 386424 cases, and North America for 255782 cases[19,20] - The annual procedure opportunity for Focal One HIFU in prostate cancer is estimated at 470000 globally, including 165000 in Europe, 130000 in Asia, and 100000 in North America[25] Clinical Evidence & Technology - Over 1000 peer-reviewed publications support HIFU in the treatment of prostate cancer[36] - A comparative study (HIFI) showed comparable cancer control with HIFU (90% STFS) versus radical prostatectomy (86% STFS), with superior functional outcomes for HIFU[41,45] - A randomized controlled trial (FARP) demonstrated equivalent oncologic control at 3 years (935% TFF for Focal Ablation vs 915% for Radical Prostatectomy) and superior functional outcomes after focal ablation[54] - The company's Focal One system has 11 systems in the NY/NJ MSA at the end of 2024 and 67 systems in the US at the end of Q1 2025[104,107] Reimbursement & Expansion - Medicare reimbursement for HIFU is $9247 in 2025, a 54% increase, and physician payment is $951[70,73] - The company is targeting large incidence cancer and benign conditions, including 15 million prostate cancer cases, 113 million BPH cases, and 205 million rectal endometriosis cases[89]

EDAP TMS (EDAP) 2025 Conference June 05, 2025 04:20 PM ET Speaker0 Okay. Alright. Good afternoon. My name is Michael Sarcone. I'm an analyst on the US Medical Supplies and Devices team, this is day two of the Jefferies twenty twenty five New York Healthcare Conference. This is a session with EDAP Focal One. And with us from the company, we've got Ryan Rhodes, CEO Ken Moback, CFO and John Francis who heads the IR function. Ryan Rhodes is going to give a presentation, some prepared commentary and then we'll o ...

AUSTIN, Texas, May 15, 2025 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, reported today unaudited consolidated financial results for the first quarter of 2025. "Demand for Focal One remains on a solid growth trajectory, as demonstrated by our strong first quarter system placements. We placed a record number of nine Focal One systems, which is the highest number of placements for any first quarter in our company's history," said Ryan Rhodes, Chief Executive Officer of ED ...

"The positive results from the FARP randomized controlled trial further validate the role of robotic focal ablation with ultrasound energy in the management of prostate cancer," said Ryan Rhodes, Chief Executive Officer of EDAP TMS. "Focal One Robotic HIFU was used for the vast majority of the patients treated with focal ablation in this study. This demonstrates Focal One's leadership position in the rapidly growing treatment category of focal therapy for prostate cancer. We anticipate that the positive dat ...