Latest news with #FocalOne
Yahoo
16-05-2025
- Business
- Yahoo
Edap TMS SA (EDAP) Q1 2025 Earnings Call Highlights: Record Focal One Placements Amid Revenue ...
HIFU Revenue: 6.2 million, up 6.8% from 5.8 million in Q1 2024. Total Worldwide Revenue: 13.6 million, a decrease of 9.1% from 14.9 million in Q1 2024. Gross Profit: 5.7 million, down from 6.4 million in Q1 2024. Gross Profit Margin: 42%, compared to 42.8% in Q1 2024. Operating Expenses: 11.7 million, up from 11.2 million in Q1 2024. Operating Loss: 6 million, compared to 4.8 million in Q1 2024. Net Loss: 7.1 million or 0.19 per diluted share, compared to 4.5 million or 0.12 per diluted share in Q1 2024. Cash and Cash Equivalents: 22.8 million at the end of Q1 2025, down from 29.8 million at the end of Q4 2024. Inventory: 18 million at the end of Q1 2025, down from 18.5 million at the end of Q4 2024. Warning! GuruFocus has detected 3 Warning Signs with EDAP. Release Date: May 15, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Edap TMS SA (NASDAQ:EDAP) placed a record nine Focal One systems in the first quarter of 2025, marking the highest number of placements for any first quarter period in the company's history. Focal One received CE mark approval for the treatment of posterior deep infiltrating endometriosis, expanding its potential market in Europe. The company launched the new Focal One I robotic HIFU system at the 2025 AUA meeting, showcasing advancements in their technology. Positive results from the FARP randomized controlled trial were presented, supporting the efficacy of robotic focal therapy for prostate cancer. The world's first remote transatlantic Focal One robotic HIFU procedure was conducted, highlighting the system's innovative capabilities and potential for remote operations. Total worldwide revenue decreased by 9.1% compared to the same period in 2024, primarily due to declines in non-core ESWL and distribution divisions. Operating loss increased to 6 million in the first quarter of 2025, compared to 4.8 million in the first quarter of 2024. Net loss for the first quarter of 2025 was 7.1 million, a significant increase from the 4.5 million net loss in the year-ago period. The company is experiencing longer and more challenging review and procedure approvals, particularly for patients enrolled in Medicare Advantage plans. A 10% tariff impact is forecasted for goods transferred from France to the US in the second quarter, potentially affecting costs and profitability. Q: Ryan, you mentioned changing trends in the payer landscape with longer and more challenging reviews and procedure approvals. Can you elaborate on this? Is it specific to Medicare Advantage, or is it broader? A: The trends are specific to Medicare Advantage Plan patients. Approximately 54% of patients on Medicare opt for a Medicare Advantage plan. We are working closely with consulting firms to navigate this process, and while there are some denials, we are seeing progress with appeals and approvals. Q: Are the challenges with payer approvals continuing into Q2, and are you able to get procedures approved despite delays? A: There is always a risk of denials, but we are making notable progress with appeals. We work closely with institutions and consulting partners, and we win the majority of appeals. Q: Ken, you've maintained your HIFU sales growth guidance of 16% to 25%. What assumptions are incorporated at the low and high ends of this range? Are you expecting an acceleration in procedure growth? A: The capital equipment environment is lumpy, but we have factored in procedure growth in our forecast. We remain confident in achieving the 16% to 25% HIFU revenue growth range for the year. Q: With the CE mark approval for endometriosis, what are your next steps for marketing Focal One in Europe, and what are your plans for the US? A: We are embarking on a controlled market entry in CE countries, working with initial hospitals to expand clinical development efforts. In the US, we are tracking data from phase two and three studies to use in future FDA interactions, while focusing on the controlled launch phase in Europe. Q: Can you provide more details on the strategic focus and recent achievements of Edap TMS? A: We are focused on becoming the global leader in focal therapy. Recent achievements include record placements of Focal One systems, CE mark approval for endometriosis treatment, and the launch of the new Focal One I robotic HIFU system. These milestones reflect our strategic focus and growing demand for Focal One. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Khaleej Times
30-01-2025
- Health
- Khaleej Times
American Hospital Dubai introduces no surgery, no radiation treatment for prostate cancer patients
American Hospital Dubai introduces the region's first Focal One® Robotic High-Intensity Focused Ultrasound (HIFU) procedures for prostate cancer patients. The state-of-the-art technology uses ultra-precise, high-intensity, focused ultrasound waves to destroy malignant tissue in the prostate while preserving the healthy surrounding tissue. The concentration of the ultrasound waves at super-localised spots in the prostate creates heat that kills the cancerous cells. American Hospital Dubai is the first private healthcare provider to bring this highly advanced, state-of-the-art robotic treatment option to the region, further strengthening its robotic surgery excellence and its commitment to providing the most advanced robotic medical care in the UAE and the region. A groundbreaking HIFI study in 2024, published in the prestigious European Urology journal, demonstrated HIFU's effectiveness and efficacy. The study concluded that HIFU achieves oncological outcomes comparable to traditional surgery, while delivering superior functional results. The study was the most extensive prospective comparative oncological clinical study to compare prostate cancer treatments. The Focal One® Robotic HIFU is a boon for patients seeking prostate cancer treatment without the stress of surgery, cutting or radiation. The procedure is non-invasive and can be completed in a single session under general anesthesia, reducing the risk of side effects such as incontinence or erectile dysfunction. Focal One's® Dynamic Focusing Probe, which produces ultrasound waves, delivers high-resolution real-time ultrasound imaging covering an expanded area and ablating three times faster than other technologies, proving a valuable advantage for surgeons and patients. Focal One® Robotic HIFU procedure is an advantage for patients and healthcare teams. It reduces overall treatment costs through shortened hospital stays, quicker recovery times, and minimum complications compared to traditional prostate surgery. Adding Focal One® Robotic HIFU to American Hospital Dubai's dedicated Prostate Clinic further consolidates the Clinic's role as a one-stop, state-of-the-art facility in the region offering a full range of diagnostics and treatments for all prostate-related conditions. The Clinic provides the best turnaround time (TAT) with same-day prostate testing and diagnosis and same-day consultation to devise the best treatment plan for patients. American Hospital Dubai's excellence in robotic surgery has earned its Center of Excellence in Robotic Surgery (COERS) accreditation from the US-based Surgical Review Corporation (SRC). The hospital is the first private healthcare facility in the region to earn this recognition. Sherif Beshara, group CEO of American Hospital Dubai, said: 'We are excited to introduce the revolutionary Focal One® Robotic HIFU to the region. At American Hospital Dubai, we are committed to bringing patients the latest medical advancements. Focal One® Robotic HIFU technology reinforces our dedication to delivering world-class care while prioritising patient quality of life. We are renowned for our excellence in robotic surgeries, and Focal One® Robotic HIFU iterates our patient-centric care values.'
