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Micro-ultrasound with ExactVu Proven Non-Inferior to MRI for Prostate Cancer Diagnosis in OPTIMUM Randomized Trial
Study data, published in JAMA and presented at EMUC 2025, suggest ExactVu is
potential MRI alternative for image-guided prostate biopsy
MARKHAM, Ontario – November 17, 2025 – Exact Imaging today announced that results from its OPTIMUM clinical trial demonstrating the non-inferiority of its ExactVu™ micro-ultrasound platform to MRI fusion-guided biopsy for diagnosing prostate cancer were presented on Nov. 14 by Dr. Laurence Klotz at the European Multidisciplinary Congress on Urological Cancers (EMUC) in Prague. Also published in JAMA, the study data suggest that ExactVu could provide an alternative to MRI for image-guided prostate biopsy.
“These results are a game-changer for urologists and patients, as we now have an in-office diagnostic tool proven non-inferior to MRI that is easy-to-use, affordable and speeds the diagnosis process for patients,” said Dr. Klotz, Professor, Department of Surgery, University of Toronto and Chair of Prostate Cancer Research, Sunnybrook Health Sciences Center. “I believe the technology has the potential to improve standard of care and reduce care disparities, especially for those with limited access to MRI.”
OPTIMUM was a multicenter, international, open-label, randomized, non-inferiority trial of 802 biopsy-naive men with clinical suspicion of prostate cancer. Spanning 20 centers and eight countries, the study’s primary outcome was the difference in detection of Gleason Grade Group 2 or higher cancers using ExactVu micro-ultrasonography plus systematic biopsy versus MRI/conventional ultrasonography plus systematic biopsy. The secondary outcome was the difference in detection of Gleason Grade Group 2 or higher cancers found using ExactVu micro-ultrasonography/MRI plus systematic biopsy versus MRI/conventional ultrasonography plus systematic biopsy, all with a noninferiority margin of 10%. The data showed that ExactVu was able to identify prostate cancer as effectively as MRI-guided biopsy, with very similar rates of detection across all arms of the trial.
“The JAMA publication of the OPTIMUM trial and its subsequent presentation at EMUC 2025 are major validations for micro-ultrasound technology and a defining milestone for the company,” said Randy AuCoin, president and CEO, Exact Imaging. “The results underscore the transformative potential of micro-ultrasound to make high-quality prostate imaging available to every patient, regardless of access to MRI.”
Unlike traditional ultrasound, the ExactVu micro-ultrasound platform operates at 29 MHz, enabling a new level of resolution that allows urologists to visualize areas of interest in the prostate and specifically target biopsies to those areas. For those cases where MRI might assist, the FusionVu™ micro-US/MRI fusion application operates on the ExactVu micro-ultrasound platform and facilitates fast, simple MRI fusion-based targeting with the guidance of the micro-ultrasound system’s 70-micron real-time resolution.
Ongoing research also confirms that ExactVu supports a wide range of clinical applications for urology practices, from active surveillance and focal therapy guidance to surgical planning, making it a versatile platform that grows with the evolving needs of modern prostate care.
For more information visit https://www.exactimaging.com/exactvu-micro-ultrasound-system.
About Exact Imaging
Exact Imaging is the world’s leader in high-resolution micro-ultrasound systems enabling real-time imaging and guided biopsies in the urological market for prostate cancer. Its ExactVu™ micro-ultrasound platform and FusionVu™ micro-US/MRI fusion application have received regulatory approval in the European Union (CE Mark), the United States (FDA 510(k)) and Canada (Health Canada medical device license).
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