EDAP Announces Preliminary Fourth Quarter Record Focal One System Sales and Placements

Company reports preliminary placement results of twelve Focal One Systems, inclusive of ten capital sales

LYON, France, January 8, 2024 - EDAP TMS SA (Nasdaq: EDAP), (“EDAP”), the global leader in robotic energy-based therapies, announced today preliminary Focal One placement results for the fourth quarter of calendar year 2023. The Company experienced robust demand for its Focal One robotic HIFU technology, placing twelve Focal One systems, inclusive of ten capital sales. Additionally, it was a record quarter for sales of ExactVu Micro-Ultrasound systems used for prostate biopsy. The breadth of these new Focal One and ExactVu placements continues to be strong, with growing interest amongst both academic medical centers and community hospitals.  

“Our Focal One commercial team continues to gain significant momentum as reflected by our record-setting number of capital sales as well as overall system placements in the fourth quarter of 2023,” said Ryan Rhodes, Chief Executive Officer of EDAP. “Utilizing our state-of-the-art robotic technology platform, a growing number of urologists can now offer their patients a non-invasive, tissue-sparing treatment option that provides excellent oncologic outcomes with the opportunity for preserving patient quality of life. Looking ahead, we believe Focal One is quickly becoming a necessary solution in the management of prostate cancer, and our team is leading the effort to help urology practices establish world-class treatment programs with our Focal One platform.”

The above information is preliminary and subject to completion of quarter-end financial reporting processes and reviews. EDAP expects to release final fourth quarter financial results in March.

About EDAP TMS SA

A recognized leader in the global therapeutic ultrasound market, EDAP TMS develops, manufactures, promotes and distributes worldwide minimally invasive medical devices for various pathologies using ultrasound technology. By combining the latest technologies in imaging and treatment modalities in its complete range of Robotic HIFU devices, EDAP TMS introduced the Focal One in Europe and in the U.S. as an answer to all requirements for ideal prostate tissue ablation. With the addition of the ExactVu Micro-Ultrasound device, EDAP TMS is now the only company offering a complete solution from diagnostics to focal treatment of Prostate Cancer. EDAP TMS also produces and distributes other medical equipment including the Sonolith i-move lithotripter and lasers for the treatment of urinary tract stones using extra-corporeal shockwave lithotripsy (ESWL). For more information on the Company, please visit http://www.edap-tms.com, us.hifu-prostate.com and www.focalone.com.