EDAP announces sale of Robotic Focal One HIFU device to University of Miami

EDAP TMS, the global leader in robotic energy-based therapies, today announced that the University of Miami Sylvester Comprehensive Cancer Center is the latest highly-regarded health care institution to acquire Focal One, the most advanced technology available for delivering high intensity focused ultrasound (HIFU) to target and ablate diseased prostate tissue.

The Sylvester Cancer Center was one of the first hospitals in the U.S. to offer HIFU using EDAP’s Ablatherm system, with more than 100 patients successfully treated to date, and the medical center has already performed multiple treatments using Focal One. The evolution from Ablatherm to Focal One allows Sylvester Cancer Center to continue to offer the latest generation HIFU to men with localized prostate cancer.

“Our commitment is to always be at the forefront of healthcare technology for our patients,” said Dipen Parekh, MD, Chairman of the Urology Department at the University of Miami Miller School of Medicine and Chief Clinical Officer of University of Miami Health System. “We believe focal therapy – and HIFU — represents a promising alternative for some of our prostate cancer patients, targeting the disease with minimal-to-no impact on their quality of life. When the next generation HIFU system, Focal One, was cleared by the FDA, we were excited to move to this new device which gives us even greater precision and customization for each patient.”

Marc Oczachowski, Chief Executive Officer of EDAP, added: “We are very pleased to continue and strengthen our partnership with such a prestigious academic center by providing them the latest state of the art HIFU technology available on the market. This represents a strong vote of confidence for our company and our team, and it also confirms the advantages of Focal One versus the previous generation of HIFU devices, including Ablatherm. We are very excited to see increasing traction and interest in Focal One from both existing users and new prospects.”

The University of Miami also led the charge, along with other esteemed medical institutions, to launch the Focal Robotic Ultrasound Ablation Registry (FoR-UsA Registry).  The Registry is being used to track baseline and follow-up information on patients undergoing HIFU, initially using Ablatherm and now Focal One.

Focal One fuses MRI and biopsy data with real-time ultrasound imaging that allows urologists to view integrated, detailed 3D images of the prostate and direct high intensity ultrasound waves to ablate the targeted area. Focal One enables urologists to establish more precise contours around diseased tissue and ablate a smaller portion of the prostate, which lessens the damage to healthy tissue and minimizes the risk of serious side effects, most notably incontinence and impotence.