Lyon, France, Austin, TX – June 23, 2020 – EDAP TMS SA (Nasdaq: EDAP) has inked an agreement with Exact Imaging to be the sole distributor of ExactVu™ Micro-Ultrasound (Micro-US) worldwide, and especially in the U.S. market. ExactVu Micro-US is purpose built for urologists to diagnose prostate cancer. It dramatically improves visualization of suspicious areas of the prostate over standard ultrasound, better guides biopsies and helps urologists determine, with certainty, the grade and stage of cancer if it is detected.

"ExactVu Micro-US has revolutionized the way we look for cancer in the prostate and the way we biopsy," said Gerald Andriole, M.D., chief of urologic surgery and vice chair of the department of surgery at Washington University School of Medicine in St. Louis. "This device takes pictures of the prostate using 29 MHz compared to 7.5 MHz in standard ultrasound. Consequently, it provides much more detailed images of what's going on in the prostate and we can see the precise location of most prostate cancers that is at least as good as an MRI scan."

ExactVu Micro-US now makes standard ultrasound seems like hitting a piñata blindfolded

Typically, when a patient has an elevated PSA test, the urologist will take the next step -- perform a standard ultrasound to look throughout the prostate and guide the biopsy to detect cancer. But with the limitations of traditional ultrasound he is essentially doing the biopsy blind, taking an average of 12 random core samples in different areas with the possibility of a false negative or under-graded prostate cancer diagnosis.

Or, in one sample the doctor might biopsy an actual tumor, which shows aggressive cancer and a high Gleason score, which is the grade of the cancer. But a biopsy taken in an area right next to the tumor could be less aggressive (lower Gleason score) or even benign, making an accurate diagnosis difficult and in some cases requiring another ultrasound and series of biopsies down the road.

Moreover, with an imprecise diagnosis and to avoid any risk, the urologist may recommend the patient have a radical prostatectomy or radiotherapy to surgically remove or radiate the entire prostate, rendering the patient sexually impotent and incontinent as a result. Whereas a sure diagnosis may show that the patient can stay confidently under Active Surveillance because of a true low-risk cancer or is a candidate for focal therapy using high intensity focused ultrasound -- and EDAP's Focal One system. Focal One HIFU targets and treats only the diseased portion of the prostate and leaves the remaining prostate – and the patient's quality of life -- intact.

ExactVu Micro-US delivers 300 percent higher resolution than standard ultrasound

Using ExactVu Micro-US, doctors benefit from a 300 percent improvement in resolution over conventional ultrasound for more precise diagnosis. Doctors use live Micro-US images for better detection and evaluation of the aggressiveness level of the cancer.

The urologist's ability to view the patient's anatomy, detect suspicious areas, differentiate between benign and cancerous tissue, and target specific areas for biopsy makes Micro-US technology the new standard of care.

All the quality of an MRI at lower cost

Also, with Micro-US, urologists get the same high quality visualization as an MRI to guide the biopsies. So rather than sending the patient for an MRI, which is an additional imaging procedure that needs to be billed independently – and not always covered by insurance – the Micro-US-guided biopsy is performed in the same setting as the standard ultrasound-guided biopsy, and is always covered by insurance.

"Besides being as good as an MRI scan, Micro-US can be done in the urologist's office, at lower cost," Dr. Andriole said. "Also, for some patients who are claustrophobic or have a pacemaker, MRI may be prohibitive. With Micro-US we can advance the biopsy needle right up to the edge of the suspicious area, press the button and the biopsy core will go right through the most worrisome part of the prostate. The accuracy of finding a cancer within the prostate, if there is one, is much higher."

For more information about ExactVu Micro-US visit https://us.edap-tms.com/home/us.


About EDAP TMS
A recognized leader in the global therapeutic ultrasound market for almost 40 years, EDAP TMS develops, manufactures, promotes and distributes worldwide minimally-invasive medical devices for urology 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® (currently pending FDA clearance) in 2013 as the answer to all requirements for ideal prostate tissue ablation as a complement to the existing FDA cleared Ablatherm® Robotic HIFU and Ablatherm® Fusion. As a pioneer and key player in the field of extracorporeal shock wave lithotripsy (ESWL), EDAP TMS exclusively utilizes the latest generation of shock wave source in its Sonolith® range of ESWL systems. For more information on the Company, please visit http://www.edap-tms.com, and us.hifu-prostate.com.