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EDAP TMS SA (Nasdaq: EDAP) is described in its filings and press releases as a global leader in robotic energy-based therapies, focused on High-Intensity Focused Ultrasound (HIFU) and related ultrasound-based medical devices. The EDAP news feed on Stock Titan aggregates company announcements, financial updates and regulatory disclosures so readers can follow developments around its Focal One Robotic HIFU platform and broader therapeutic ultrasound portfolio.
Recent news from EDAP highlights HIFU revenue growth, system placements and procedure volumes, as well as guidance on expected revenue trends in its core HIFU business and non-core ESWL and Distribution segments. The company regularly reports unaudited quarterly financial results via Form 6-K, including details on sales of medical equipment, recurring revenue programs, and spare parts and services, along with commentary on gross margins and operating performance.
Investors and healthcare observers can also use the news stream to track regulatory milestones and clinical adoption. EDAP has announced FDA 510(k) clearance for new ultrasound imaging and workflow enhancements to the Focal One HIFU system, as well as reimbursement in France for Focal One Robotic HIFU procedures in prostate cancer under the national universal health system. News items further cover recognition such as an Industry Award for Innovations in Endourological Instrumentation for the Focal One platform.
Other news categories include financing and capital structure updates, such as a multi-tranche credit facility with the European Investment Bank intended to support expansion of the Focal One platform, and information about EDAP’s transition from foreign private issuer to U.S. domestic filer status. Coverage of conference presentations and investor meetings provides additional context on how management presents the company’s strategy in urology, prostate cancer and benign disease markets.
By reviewing the EDAP news page, readers can follow company-reported trends in HIFU adoption, reimbursement developments, clinical evidence references and financial guidance, all drawn from EDAP’s own press releases and SEC-reported materials.
EDAP TMS SA (Nasdaq: EDAP) and Avenda Health have launched the world's first AI-assisted Focal One® Robotic HIFU procedures for prostate cancer treatment. The collaboration integrates Avenda's FDA-cleared Unfold AI® technology with EDAP's Focal One robotic HIFU platform. Unfold AI creates 3D patient-specific cancer maps, enabling more precise tumor targeting and healthy tissue preservation.
The first AI-assisted procedures were successfully performed at UCLA School of Medicine. This integration aims to provide more tailored, patient-specific HIFU ablation for prostate cancer patients. The companies will present simulated procedures at the 2024 Joint Meeting of the Focal Therapy Society & Society of Urologic Robotic Surgeons in Washington, DC.
EDAP TMS SA (Nasdaq: EDAP), a leader in robotic energy-based therapies, announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference. The event is scheduled for September 9-11, 2024, in New York City. Ryan Rhodes, EDAP's CEO, will engage in a fireside chat and conduct one-on-one investor meetings.
Key details:
- Date: Tuesday, September 10th, 2024
- Time: 3:00-3:30 PM ET
- Location: Lotte New York Palace Hotel
EDAP TMS SA reported record Q2 2024 total worldwide revenue of EUR 15.8 million (USD 17.0 million), a 10.6% increase over Q2 2023. The company experienced strong U.S. Focal One® HIFU procedure growth of 63% year-over-year. Key highlights include:
- Five Focal One systems placed in Q2, including two at NCI-designated comprehensive cancer centers
- Strong year-over-year procedure growth indicating increasing adoption of robotic HIFU
- Appointment of new board member and strengthened European commercial leadership
- Presentation of final HIFI study results at AUA 2024, showing Focal One as effective as radical prostatectomy for localized prostate cancer
- Interim results from Phase 3 endometriosis study and approval to initiate Phase 1-2 BPH clinical trial
Despite revenue growth, the company reported an operating loss of EUR 6.1 million for Q2 2024, compared to EUR 4.2 million in Q2 2023, due to increased investments in commercial and R&D functions.
EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, has announced it will release its financial results for the second quarter ended June 30, 2024, before markets open on Wednesday, August 28th, 2024. The company will host a conference call and webcast on the same day at 8:30am EDT.
The call will be conducted by Ryan Rhodes (CEO), Ken Mobeck (CFO), and François Dietsch (Chief Accounting Officer). Investors can join the call using the provided domestic and international dial-in numbers or through the webcast link.
EDAP TMS SA (Nasdaq: EDAP) announced that its robotic HIFU technology platform, Focal One, will be featured at the 41st World Congress of Endourology and Uro-Technology (WCET 2024) in Seoul, South Korea, from August 12-16, 2024. The event will showcase a semi-live Focal One clinical procedure conducted by Dr. Tarik Benidir from the University of Florida on August 15th at 5:00 pm (KST).
CEO Ryan Rhodes highlighted the increasing interest from urologists in using non-invasive HIFU technology for prostate cancer management. The company will provide hands-on Focal One simulations for attending urologists, demonstrating EDAP's significant presence at the conference and the growing trend in HIFU technology adoption.
EDAP TMS SA (Nasdaq: EDAP) announced interim results from its Phase 3 study evaluating robotic High-Intensity Focused Ultrasound (HIFU) therapy for deep infiltrating endometriosis. The study, involving 60 patients, aimed to assess acute pelvic pain levels. Key findings include:
1. Robotic HIFU therapy maintained an excellent safety profile, confirming results from earlier studies.
2. The primary endpoint of reduced acute pelvic pain in the HIFU arm compared to the Sham arm was not met at three months.
3. Both arms showed significant reduction in pelvic pain scores from baseline.
4. HIFU-treated patients experienced higher volume reductions in endometriosis nodules compared to the Sham arm.
5. The study continues, with Sham arm patients electing HIFU therapy after pain returned to baseline.
EDAP TMS (Nasdaq: EDAP), a global leader in robotic energy-based therapies, announced the appointment of Fran Schulz to its Board of Directors on July 8, 2024.
Schulz, an executive with over 35 years of experience in the healthcare industry, brings extensive expertise in strategic finance, accounting, and regulatory issues. She has been involved in over 100 equity and debt transactions, raising more than $15 billion.
Her appointment aims to strengthen EDAP's leadership as the company expands its Focal One platform globally. Schulz will advise on strategic growth initiatives, including expanding robotic HIFU technology to treat various diseases.
EDAP TMS SA, a leader in robotic energy-based therapies, announced new executive appointments to strengthen its European and Middle Eastern commercial operations. Damien Desmedt is appointed Vice President of Sales for EMEAI, bringing over 30 years of experience in healthcare innovations and robotic surgery. Alexander Fromm will serve as General Manager for Switzerland, overseeing strategic European territories with over 25 years in the medical device industry. The aim is to grow the Focal One technology platform and expand robotic HIFU applications in women’s health to meet unmet needs.
EDAP TMS SA, a leader in robotic energy-based therapies, announced that CEO Ryan Rhodes will present and host investor meetings at the Jefferies Global Healthcare Conference on June 5-6, 2024, in New York City. The presentation is scheduled for June 5th at 7:30 AM ET. A live and archived webcast will be accessible on the company's website.
EDAP reported robust growth in Q1 2024 with a significant 92% increase in U.S. Focal One® HIFU procedures year-over-year. HIFU revenue rose 10.2% to EUR 5.8 million ($6.3 million), contributing to a total revenue of EUR 14.9 million ($16.1 million), up 0.8% from Q1 2023. Gross profit increased to EUR 6.4 million ($6.9 million), driven by higher treatment revenues. Operating expenses dropped to EUR 11.2 million ($12.1 million) due to a non-recurring compensation expense in Q1 2023. Despite an operating loss of EUR 4.8 million ($5.2 million), net loss improved to EUR 4.5 million ($4.9 million) from EUR 7.5 million ($8.1 million) in Q1 2023. Additionally, EDAP's Phase 3 study on endometriosis is expected to yield results in the latter half of 2024.