LYON, France - EDAP TMS SA (NASDAQ:EDAP), a developer of therapeutic ultrasound devices, has launched a Phase I/II clinical trial to assess its Focal One robotic high-intensity focused ultrasound (HIFU) technology for benign prostatic hyperplasia (BPH) treatment. The first patients have recently been treated as part of this study.
The trial is a company-sponsored, prospective, multicenter study conducted at two prominent academic prostate treatment centers in France. The first part of the study aims to establish optimal treatment parameters to address BPH symptoms with minimal side effects. The second part will broaden patient enrollment across more centers to validate the safety and efficacy of these parameters.
Harry Toledano, MD, Head of the Urology Department at Martigues Hospital, expressed optimism about the potential of the HIFU technology, which has been used in prostate cancer treatment at their facility for over 15 years. He anticipates the technology could offer BPH patients a less invasive treatment option with a quick return to normal activities.
Ryan Rhodes, CEO of EDAP TMS, highlighted the millions of men affected by BPH annually and the need for less invasive treatments. He believes that Focal One could provide a solution that maintains the integrity of the urethra and other critical structures. The study's findings are expected to lay the groundwork for a similar clinical trial in the United States next year.
EDAP TMS has a history in the therapeutic ultrasound market, offering devices for various pathologies, including prostate cancer diagnostics and focal treatment. The company also develops and distributes equipment for urinary tract stone treatment.
The press release includes forward-looking statements that involve risks and uncertainties. These statements are based on current expectations and could be affected by factors such as market acceptance of HIFU devices, economic conditions, and other risks outlined in the company's SEC filings. The information provided in this article is based on a press release statement from EDAP TMS SA.
In other recent news, EDAP TMS has reported a 10.6% increase in total worldwide revenue, reaching $15.8 million for the second quarter of 2024. This growth is largely due to the strong performance and increasing acceptance of its Focal One high-intensity focused ultrasound (HIFU) technology for the treatment of localized prostate cancer. The company has also observed a significant uptick in U.S. procedure growth and advancements in clinical trials for both prostate cancer and benign prostatic hyperplasia (BPH).
Five Focal One systems were placed in the second quarter, including at City of Hope and Robert Wood Johnson University Hospital. Interim Phase III results for robotic HIFU in endometriosis treatment showed promising safety and efficacy, and approval was received for a Phase I/II trial for Focal One HIFU in BPH treatment. The company is making strategic appointments and increasing its presence in urology-focused scientific meetings.
However, it is worth noting that operating expenses have increased due to the expansion of commercial operations and R&D investments. The company reported a net loss of EUR 6.1 million for the second quarter due to lower volumes and operating leases impacting margins in the HIFU segment. Despite these challenges, EDAP TMS continues to demonstrate its commitment to advancing its HIFU technology and expanding its market presence.
InvestingPro Insights
As EDAP TMS SA (NASDAQ:EDAP) embarks on its Phase I/II clinical trial for BPH treatment using its Focal One robotic HIFU technology, investors should consider some key financial metrics and insights from InvestingPro.
Despite the potential of EDAP's innovative technology, the company's financial performance has been challenging. According to InvestingPro data, EDAP's revenue for the last twelve months as of Q2 2024 stood at $66.47 million, with a revenue growth of 8.79%. While this growth is positive, it's important to note that the company is not currently profitable, with an operating income margin of -26.74% for the same period.
InvestingPro Tips highlight that EDAP is quickly burning through cash, which could be a concern given the costs associated with clinical trials and product development. However, it's worth noting that the company holds more cash than debt on its balance sheet, providing some financial flexibility.
The stock's recent performance has been notably weak, with InvestingPro data showing a 51.15% decline in the three-month price total return as of the latest data. This decline has pushed the stock near its 52-week low, with the current price at just 30% of its 52-week high.
For investors considering EDAP's long-term potential, it's crucial to weigh the company's innovative pipeline against its financial challenges. InvestingPro offers 12 additional tips for EDAP, providing a more comprehensive analysis for those looking to delve deeper into the company's prospects.
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