EDAP TMS SA - EDAP STOCK NEWS

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.

EDAP TMS SA announced positive final results from the HIFI Study comparing Focal One® HIFU versus radical prostatectomy at the 119th AUA Annual Meeting. The study showed a higher salvage treatment free survival rate in the HIFU arm, better urinary continence and erectile function outcomes, and demonstrated the effectiveness and safety of robotic HIFU in managing localized prostate cancer. The study enrolled a total of 3,328 patients across 46 centers, highlighting the growing relevance of robotic HIFU in prostate cancer management.

EDAP TMS SA, a global leader in robotic energy-based therapies, will announce its first quarter 2024 financial results on May 16, 2024. The company will host a conference call and webcast with key executives to discuss the results. Investors can join the call to learn more about the financial performance and strategic direction of EDAP.