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EDAP inks deal with Exact Imaging to be sole distributor of ExactVu Micro-Ultrasound

Press releases may be edited for formatting or style | June 23, 2020 Business Affairs Ultrasound
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.

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