EDAP TMS SA - EDAP STOCK NEWS

EDAP TMS SA reported its second quarter 2020 results, showing total revenue of EUR 9.3 million, down 26% year-over-year due to the COVID-19 pandemic. HIFU revenue fell 44.2% to EUR 2.6 million, while Lithotripsy and Distribution revenues also declined. Gross profit decreased to EUR 4.3 million, with a margin of 46.8%. Operating profit was EUR 0.3 million, contrasting with a profit of EUR 1.7 million in Q2 2019. The company holds a strong cash position of EUR 15.7 million. Future expectations are optimistic as procedure volumes are anticipated to normalize.

EDAP TMS SA has received approval to start a Phase II multicenter clinical trial for its Focal One® HIFU technology to treat deep rectal endometriosis in France, involving 38 patients across five hospitals. The trial is set to begin in September, led by Pr. Gil Dubernard. Initial Phase I results indicated promising outcomes. The company aims to expand its HIFU applications amid rising endometriosis prevalence, affecting approximately 176 million women globally. The initiative aligns with EDAP's strategic focus on enhancing its HIFU pipeline for high-value medical indications.

EDAP TMS SA (Nasdaq: EDAP) announced it will release its second quarter financial results for 2020 on August 26, after market close. The financial results will be followed by a conference call hosted by CEO Marc Oczachowski and CFO François Dietsch on August 27 at 8:30 am EDT. The company specializes in therapeutic ultrasound and has been a leader in the field for nearly 40 years, focusing on minimally invasive medical devices for urology.

EDAP TMS SA has announced the publication of two studies in the Journal of Urology, detailing successful results of their high intensity focused ultrasound (HIFU) technology for treating prostate cancer. Conducted at USC and University of Miami, these studies demonstrate that 91% of patients avoided radical treatments after two years, with no major complications. The findings are consistent with positive European studies, further affirming the efficacy of EDAP's HIFU technology. These publications mark a significant milestone in the company's US market penetration strategy.

EDAP announced a strong sales performance during Q2 and early Q3 2020, including four sales of its Focal One systems, three of which were bundled with Exact Imaging’s ExactVu technology. New customers include Edouard Herriot University Hospital and Ochsner Medical Center, with a notable upgrade sale to Mount Sinai Health System. The CEO remarked on the recovery from COVID-19 related disruptions, noting a positive impact from their partnership with Exact Imaging. EDAP expects to maintain sales momentum through the remainder of the year and will provide further updates during the upcoming Q2 conference call.

EDAP TMS SA has appointed Marie Meynadier to its Board of Directors as of June 30, 2020. A seasoned executive, Meynadier brings over 20 years of experience in the medical technology sector, including her previous role as CEO of EOS Imaging, where she saw sales grow at a CAGR of 32% from 2012 to 2017. Chairman Marc Oczachowski expressed confidence in her ability to enhance the company's R&D and expand its HIFU technology into new applications. Meynadier emphasizes her belief in EDAP's potential within the therapeutic ultrasound market, particularly through its Focal One® solution.

EDAP TMS SA (Nasdaq: EDAP) has appointed Frank Van Hyfte as Vice President of Global Sales and Marketing, bringing over 25 years of experience in medical technology sales. He joins from Exact Imaging, where he was Executive VP of Sales and Marketing. The appointment coincides with a global distribution agreement between EDAP and Exact Imaging to integrate their technologies for prostate cancer management. CEO Marc Oczachowski highlighted Van Hyfte's success at Intuitive Surgical, emphasizing his potential to drive growth in EDAP's sales pipeline and expand market reach.

EDAP TMS SA (Nasdaq: EDAP) reported Q1 2020 revenues of EUR 7.6 million, down 24.9% year-on-year due to COVID-19 impacts. The HIFU segment saw a dramatic 50.2% decrease to EUR 1.9 million, with no Focal One units sold. The company maintains a strong cash position of EUR 18.5 million. EDAP signed a global distribution agreement with Exact Imaging to provide an end-to-end prostate cancer management solution. The company aims to refocus on HIFU and its growth opportunities, while operating expenses reduced slightly to EUR 4.5 million, resulting in a net loss of EUR 1.3 million for the quarter.

EDAP TMS SA (Nasdaq: EDAP) has signed an exclusive worldwide distribution agreement with Exact Imaging, a leader in high-resolution micro-ultrasound technologies. This partnership will allow EDAP to market ExactVu™, a diagnostic tool with proven prostate cancer diagnostic capabilities comparable to MRI, alongside its Focal One® high-intensity focused ultrasound treatment. This collaboration offers a comprehensive solution for urologists in prostate cancer management, potentially serving as a significant growth driver for EDAP.