Study data, published in JAMA and presented at EMUC 2025, suggest ExactVu is potential MRI alternative for image-guided prostate biopsy
Exact Imaging today announced 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. The results of the study, which was published in JAMA and simultaneously presented at the EAU's Annual Meeting in March 2025, demonstrate 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 non-inferiority 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 non-inferiority 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. Both the primary and secondary outcomes were successfully achieved, with very similar rates of detection across all arms of the trial.
"The JAMA publication and EAU presentation 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 high quality, well-interpreted MRI is available, the FusionVu feature of the ExactVu micro-ultrasound platform facilitates a fast, simple, elastic fusion procedure, complementing the power of the MRI with 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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