LYON, France – EDAP TMS SA (NASDAQ:EDAP), a company specializing in therapeutic ultrasound, announced interim results from its Phase 3 study of robotic High-Intensity Focused Ultrasound (HIFU) for treating deep infiltrating endometriosis.
The study did not meet its primary endpoint of reducing acute pelvic pain compared to a sham procedure at three months. Still, the therapy maintained a strong safety profile and showed a reduction in endometriosis nodule volume.
The randomized, double-blind trial involved 60 patients, split between those receiving HIFU and a sham treatment. Although both groups experienced a significant reduction in pelvic pain scores, the difference between them was not statistically significant at the three-month mark.
Professor Gil Dubernard, the study's Principal Investigator, noted that the follow-up period might have been too brief to reveal meaningful differences in pain scores.
Despite not meeting the primary endpoint, the volume of endometriosis nodules was reduced more in the HIFU group, as confirmed by MRI scans. This supports the treatment's therapeutic effect, aligning with earlier Phase 1 and Phase 2 study outcomes.
Ryan Rhodes, CEO of EDAP TMS, expressed optimism that longer-term benefits would emerge, citing stabilization of pain scores at six and twelve months in the Phase 2 study. The company anticipates further updates later in the year, with additional patients from the sham group opting for HIFU therapy as per study protocols.
Endometriosis affects nearly 10-12% of women of reproductive age, with symptoms often severe and debilitating. HIFU therapy, as provided by EDAP TMS, offers a non-invasive treatment option that continues to be evaluated for efficacy and safety.
The information in this article is based on a press release statement from EDAP TMS SA. The company is known for its innovative solutions in the therapeutic ultrasound market, including the Focal One® device for prostate tissue ablation and the Sonolith® i-move for urinary tract stone treatment. The forward-looking statements in the press release are subject to various risks and uncertainties and do not guarantee future performance.
In other recent news, EDAP TMS SA has reported a 10% year-over-year revenue increase to $16.1 million in the first quarter of 2024, primarily due to a 92% rise in High-Intensity Focused Ultrasound (HIFU) procedure volume.
The company has also announced the appointment of Fran Schulz to its Board of Directors, bringing her extensive experience in strategic finance, accounting, and regulatory issues. H.C. Wainwright reiterated a Buy rating on EDAP TMS shares, maintaining a steady price target of $19.00, based on the company's recent performance and future growth potential.
EDAP TMS is also conducting a Phase 3 study on Focal One HIFU for treating deep infiltrating rectal endometriosis, with results expected in the latter half of 2024. Moreover, the company placed seven Focal One units, entering new geographic markets and adding systems in existing U.S. hospitals. These recent developments illustrate the ongoing efforts of EDAP TMS to advance therapeutic ultrasound technology.
InvestingPro Insights
As EDAP TMS SA (NASDAQ:EDAP) navigates the clinical trial landscape with its HIFU technology for endometriosis treatment, investors and stakeholders may find it useful to consider several financial metrics and expert analyses. Despite the recent clinical setback, EDAP's financial health appears robust with a market capitalization of 184.03 million USD, indicating a solid investor base and market confidence in its potential.
An InvestingPro Tip worth noting is that EDAP holds more cash than debt on its balance sheet, which is a positive sign for the company's financial stability and its ability to fund ongoing research and development without the immediate need for external financing. Additionally, the company's liquid assets exceed its short-term obligations, further underscoring its financial resilience.
Still, analysts have tempered expectations, with three analysts revising their earnings downwards for the upcoming period, and predicting that the company will not be profitable this year. This is reflected in the company's negative P/E ratio of -11.21 for the last twelve months as of Q1 2024, which suggests that investors are currently valuing the company's growth prospects rather than its current earnings.
Revenue growth remains modest with a 6.38% increase in the last twelve months as of Q1 2024, yet the gross profit margin is relatively strong at 40.91%, indicating that EDAP is able to retain a significant portion of its revenue as gross profit.
For those interested in further insights, there are additional InvestingPro Tips available for EDAP at https://www.investing.com/pro/EDAP. To access these valuable resources, use the coupon code PRONEWS24 to get up to 10% off a yearly Pro and a yearly or biyearly Pro+ subscription.
Investors and analysts alike will be watching closely for future updates from EDAP, as the company's innovative approach to non-invasive medical treatments continues to show potential, despite the challenges faced in clinical trials.
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