Focal ablation shows promise in prostate cancer trial

Published 29/04/2025, 12:10
Focal ablation shows promise in prostate cancer trial

AUSTIN - EDAP TMS SA (NASDAQ:EDAP), a $81.5 million market cap leader in robotic energy-based therapies, has disclosed the final results of the Focal Ablation versus Radical Prostatectomy (FARP) Study at the 120th AUA Annual Meeting on Sunday. According to InvestingPro data, the company’s stock has surged over 48% in the past week, reflecting growing investor interest in its innovative technologies. The study concluded that focal ablation, a less invasive cancer treatment, is not inferior to radical prostatectomy in treating localized prostate cancer.

The trial, which enrolled 213 patients, aimed to provide scientific Level 1 evidence comparing the two treatments. Eduard Baco, MD, PhD, the principal investigator, stated that the study’s 36-month follow-up showed a significantly lower rate of treatment failure in the focal ablation group compared to the radical prostatectomy group.

Patients in the study were randomized to either focal ablation (FA) or radical prostatectomy (RP), with 25% of those in the RP arm crossing over to FA. The treatment failure was 5.6% in the FA arm versus 7.9% in the RP arm, demonstrating a statistical difference in favor of focal ablation.

CEO Ryan Rhodes highlighted the trial’s validation of robotic focal ablation with ultrasound energy, particularly the use of Focal One Robotic HIFU, in managing prostate cancer. The company anticipates that the trial results, along with the recently published HIFI Study, will boost the adoption of Focal One Robotic HIFU.

EDAP TMS develops and distributes minimally invasive medical devices using ultrasound technology. The company’s Focal One device is at the forefront of prostate focal therapy and is expected to expand to other indications beyond prostate cancer.

The positive outcome of the FARP trial is based on a press release statement and is part of ongoing research into less invasive treatment options for prostate cancer. As the healthcare community continues to evaluate these findings, the potential impact on treatment protocols and patient outcomes remains a key focus. With annual revenues of $66.4 million and its next earnings report due on May 14, investors are closely monitoring EDAP’s progress. InvestingPro analysis suggests the stock is currently undervalued, though analysts anticipate a sales decline in the current year. For deeper insights into EDAP’s financial health and growth prospects, investors can access the comprehensive Pro Research Report, available exclusively on InvestingPro.

In other recent news, EDAP TMS S.A. reported its fourth-quarter 2024 earnings, showing a 3.6% year-over-year revenue increase to €20.3 million. This growth was driven by a 15.7% rise in High-Intensity Focused Ultrasound (HIFU) revenue, which reached €23.8 million. Despite a net loss of €1.9 million, this was a significant improvement from the previous year’s €5 million loss. Piper Sandler adjusted its price target for EDAP to $4.50, maintaining an Overweight rating, while Jefferies downgraded the stock from Buy to Hold, lowering the price target to $2.00. H.C. Wainwright, however, maintained its Buy rating with a $19.00 target, expressing optimism about the company’s advancements in Focal One technology and its potential applications in pancreatic cancer and benign prostate hyperplasia (BPH). EDAP TMS is actively conducting Phase 1/2 studies for these conditions, highlighting its focus on expanding market opportunities. The company’s strategic shift towards HIFU and discontinuation of non-HIFU hardware sales is expected to impact revenue projections through 2026. These developments reflect a mixed outlook from analysts, with varying expectations for EDAP TMS’s future performance.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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