Latest news with #HIFU
Yahoo
7 days ago
- Business
- Yahoo
Theraclion Growth Up in S1 2025
MALAKOFF, France, July 25, 2025--(BUSINESS WIRE)--Regulatory News: THERACLION (ISIN: FR0010120402; Mnemo: ALTHE), an innovative company developing Sonovein®, a robotic platform for non-invasive High-Intensity Focused Ultrasound (HIFU) varicose vein treatment, reviews its business for S1 2025. Sales of consumables (recurring revenue) up 30% compared to 2024 New treatment centers opened in Bulgaria and Spain Appointment of a new business manager and acceleration of commercial activities On-schedule completion of the follow-up period for the pivotal FDA clinical trial Martin Deterre, CEO of Theraclion, states: "In early 2025, Theraclion stepped up Sonovein's activity. In June, the final 12-month follow-ups for patients in the pivotal FDA-approved clinical trial were completed on-schedule. We are now awaiting the final results, which we expect to publish in September. Theraclion has also entered a business development phase: building a sales and marketing team, opening two new Sonovein treatment centers, and achieving significant growth in recurring revenue — all of which promise the achievement of our ambitious goals." Commercial activity acceleration As part of its business development, Theraclion is actively building its sales and marketing team. In May 2025, Thibault Le Normand joined the company as Chief Business Officer to boost sales in the Middle East and product placements (PPUs) of Sonovein in Europe. With over a decade of experience in international development of medical devices, Thibault Le Normand brings valuable expertise to this strategic growth phase. At the same time, the technological credibility and clinical maturity of Sonovein have been further demonstrated by the publication of new scientific articles as well as by over a dozen presentations at major international congresses by renowned physicians using the device. Sonovein's international profile has also increased through Theraclion's participation in congresses, such as Vein in Venice (April, Venice), Venous Symposium (May, New York), and the European Venous Forum (June, Krakow). This outreach effort was supported by the launch of a new product identity and a new website, giving Sonovein a new brand image that reflects innovation, clinical excellence, and ambition. In addition, two new product placement (PPU) contracts for Sonovein have been signed in Bulgaria and Spain, stepping up Theraclion's presence in Europe and expanding the installed base of the technology. Revenue for S1 2025 In K€ 06/30/2025 06/30/2024 Var. % Revenue 835 -238 from the sale of components and systems 309 -572 from the sale of consumables 372 287 30% from the sale of services 153 46 232% Other operating revenue 17 138 -88% of which Veins 832 442 of which Breast and Thyroid 3 -680 Total operating revenue 852 -100 Theraclion's revenue for S1 2025 was €835K, up 89% compared to 2024 (€442K) (prior to the non-recurring adjustment of €680K related to the cancellation of Echopulse system sales in 2024). Consumables, which include recurring revenues from PPUs, was up 30% compared to S1 2024. Service revenues were up 232% over the same period. This strong momentum is a key indicator of increasing use of Sonovein by treatment centers and reflects the technology's sustained traction in the field. Combined, consumables and services — representing recurring revenue — was up 57% compared to 2024. Progress of the pivotal FDA clinical trial In the USA, the pivotal FDA-approved study for SONOVEIN® reached a major milestone in June 2025 with the on-schedule completion of the 12-month post-treatment patient follow-ups. Data analysis is currently underway, with results expected in September. Submission of the marketing authorization application to the FDA is planned for Fall 2025, with potential approval estimated for Q2 2026, subject to the FDA's processing time. This progress marks a critical strategic milestone in the work to access the world's largest market for venous disease treatment. Next financial publication: Theraclion will publish its interim financial results on October 29, 2025. About Theraclion Theraclion is a French MedTech company committed to developing a non-invasive alternative to surgery through the innovative use of focused ultrasound. High Intensity Focused Ultrasound (HIFU) does not require incisions or an operating room, leaves no scars, and patients can immediately resume their routines. HIFU treatment concentrates therapeutic ultrasounds on an internal focal point from outside the body. Theraclion is developing SONOVEIN®, a CE-marked, a robotic platform for HIFU varicose vein treatment, which could replace millions of surgical procedures every year. In the USA, SONOVEIN® is an investigational device limited to investigational use; it is not available for sale in the USA. Based in Malakoff (Paris), the Theraclion team comprises some 30 people, most of them involved in technological and clinical development. For more information, visit and follow LinkedIn account. Theraclion is listed on Euronext Growth ParisEligible for the PEA-PME schemeMnemonic: ALTHE - ISIN code: FR0010120402LEI: 9695007X7HA7A1GCYD29 View source version on Contacts Theraclion contact Martin DeterreChief Executive Officercontact@
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
Indian Express
26-04-2025
- Entertainment
- Indian Express
Deepika Padukone swears by the HIFU treatment for glowing skin; here's how it helps combat signs of ageing
The secret behind Deepika Padukone's radiant and youthful skin isn't just expensive cosmetic treatments, but a dedicated focus on nutrition, fitness, and a solid, consistent skincare routine. In a recent Instagram post, the Singham Again actor shared behind-the-scenes footage of getting ready for a Cartier's High Jewellery event in Dubai, which entailed getting a HIFU treatment done. 'Cleansing is the foundation of good skin,' said the Piku actor, adding that 'HIFU is HIFUing.' 'When it comes to my everyday skincare routine, I just stick to the basics,' she revealed. Pointing towards a Cryo machine, she shared that it works very similarly to 'when you dunk your face in ice'. Padukone also mentioned in the video that the treatment involves using a booster, which helps 'boost collagen in your skin', and finishes the routine with LED light exposure. View this post on Instagram A post shared by दीपिका पादुकोण (@deepikapadukone) Curious, we reached out to experts to understand what makes this treatment special and why it should be part of your maintenance routine. Story continues below this ad ARTICLE CONTINUES BELOW VIDEO Dr Shareefa Chause, dermatologist at Dr Shareefa Skin Care Clinic, Mumbai, explained that High-Intensity Focused Ultrasound (HIFU) is a non-invasive cosmetic procedure that utilizes ultrasound waves to stimulate collagen production in the skin, creating a tightening effect and minimizing wrinkles and sagging. It helps combat signs of aging by boosting the skin's natural collagen production. It is a good option for individuals seeking to lift and rejuvenate their facial skin without undergoing surgery. You do not need anesthesia, surgery, or extended recovery periods, offering a safe and precise option for targeted therapy. Dr Chause recommended consulting a doctor regarding this procedure and clearing all doubts. 'The doctor will be able to determine if you are a good candidate for this procedure. If advised, follow the instructions given for optimum results,' she added. 'Ultracel Q+ is an advanced HIFU (High-Intensity Focused Ultrasound) which stimulates collagen production while targeting fat cells, providing a painless, quick, and effective way to achieve firmer, youthful skin. With results that last up to 18 months, this revolutionary treatment is perfect for facelifts, body contouring, and overall skin rejuvenation,' said Dr. Dhruvi Patel, MBBS, DDV, The Luxē Clinic Mehsana, Gujarat. According to her, investing in anti-aging treatments can also serve as a proactive approach to skincare. 'The earlier one begins to incorporate anti-aging products into their routine, the more effective they can be in slowing down the aging process. This also includes sun protection to guard against UV damage, antioxidant-rich serums to combat free radicals, and hydration techniques to maintain skin moisture,' she said, adding that establishing a solid skincare routine early on can reduce the need for more invasive treatments later in life. Proper nutrition, regular exercise, adequate hydration, and quality sleep all play crucial roles in maintaining youthful skin and a vibrant appearance. Anti-aging treatments can work in synergy with these habits, amplifying their effects and fostering an overall healthy lifestyle.
BBC News
24-04-2025
- Health
- BBC News
Northampton hospital launches new prostate cancer treatment
A pioneering non-invasive treatment for prostate cancer will be launched after a successful fundraising than £400,000 was collected to pay for a High-Intensity Focused Ultrasound (HIFU) machine at Northampton General Hospital (NGH).Doctors said the treatment is less likely to have unpleasant side effects than surgery or hospital in the east of England is planning to launch HIFU for prostate cancer later this year - the Queen Elizabeth in King's Lynn, Norfolk. NGH said about 1,000 men were diagnosed with prostate cancer every year in Northamptonshire alone, and HIFU therapy could be an option for about 200 of machine sends a beam of ultrasound energy into the prostate from a probe inserted into the sound waves are focused precisely onto the cancerous area, and the tissue is heated to a temperature that destroys the cancer cells. The associate medical director of University Hospitals of Northamptonshire (UHN), Chandran Tanabalan, said: "Focal therapy offers significant advantages over surgery and radiotherapy treatments as it treats just the part of the prostate affected by cancer."This leads to lower risks of long-term side effects like erectile dysfunction and incontinence, faster recovery times, and better quality of life post procedure that can be associated with radical surgery or radiotherapy." Northamptonshire Health Charity raised more than £400,000 for the McGee, its chief executive, said: "During the initial fundraising for the campaign, I too was diagnosed with prostate cancer. "This gave me a valuable personal perspective on the importance of this appeal, and although I am quite 'young' for a diagnosis, it shows the importance of screening.""I'm fortunate that for me it's 'watch and wait' so I may never need treatment," he added. The first patients are due to be offered the treatment within the next few weeks, and it is hoped all the equipment will be in place by the from across the East Midlands will eventually use the service at UHN chief executive, Laura Churchward, said: "We very much want UHN to be front-runners in this exciting field with so many potential benefits for our prostate cancer patients."Paul Sayer, founder of the national charity Prost8 UK, said he was "thrilled to see the NHS embracing this technology, with Northampton General Hospital leading the way. "We will be actively referring patients to the HIFU."The Queen Elizabeth Hospital in King's Lynn, Norfolk, is expecting to launch the therapy in the coming year. Follow Northamptonshire news on BBC Sounds, Facebook, Instagram and X.
CairoScene
28-03-2025
- Health
- CairoScene
American Hospital Dubai Launches Region's First Non-Invasive Prostate
The technology uses focused ultrasound waves to destroy cancerous prostate tissue while preserving healthy tissue with precision. Feb 02, 2025 American Hospital Dubai has launched the region's first Focal One Robotic High-Intensity Focused Ultrasound (HIFU) treatment for prostate cancer, offering a non-invasive alternative without surgery or radiation. Reducing hospital stays and recovery time, the advanced technology uses focused ultrasound waves to destroy cancerous prostate tissue while preserving surrounding healthy tissue, with robotic precision minimizing complications. The hospital's expertise in robotic-assisted surgery has previously earned it the Center of Excellence in Robotic Surgery (COERS) accreditation from the US-based Surgical Review Corporation (SRC), the first private healthcare facility in the region to achieve this recognition.
