Toronto, Canada -- (March 31, 2021) Exact Imaging™ (www.exactimaging.com), the world’s leader in high-resolution micro-ultrasound systems enabling real-time imaging and biopsy guidance for the prostate, and its ExactVu™ micro-ultrasound system celebrate a dramatic increase in the clinical evidence supporting micro-ultrasound over the past year.  Exact Imaging wishes to congratulate all of the clinicians and researchers who are leveraging micro-ultrasound to improve the diagnostic pathway for prostate cancer. “Your dedication and scientific rigor have built a strong foundation that clearly demonstrates the clinical potential of this new imaging modality,” says Randy AuCoin, President and CEO of Exact Imaging. 

These publications include: 

• Lughezzani et al. 2020, European Urology Focus:
  The first blinded, prospective, level 1 evidence comparing micro-ultrasound to mpMRI.  Demonstrated identical detection rates for a micro-ultrasound-based biopsy procedure to an mpMRI-fusion-based biopsy procedure. 
• Klotz et al. 2020, Canadian Urology Association Journal:
  The largest micro-ultrasound study to date with 1040 biopsy procedures across 11 institutions.  Micro-ultrasound demonstrated higher sensitivity and negative predictive value than mpMRI in this real-world registry study (p=0.03). 
• Wiemer et al. 2020, European Urology Focus:
  Micro-Ultrasound targeted biopsy found a higher-grade cancer in 26% of patients compared to non-targeted samples and MRI targeted samples in this single-center experience. 
• Cornud et al. 2020, European Radiology:
  A second-look study examining the visualization of mpMRI targets on micro-ultrasound.  When micro-ultrasound was normal, no significant cancer was found in this cohort, however micro-ultrasound did find sites of cancers missed by MRI in 24%. 
• Socárras et al. 2020, Journal of Urology:
  The Madrid Protocol for transperineal biopsy using both Micro-ultrasound and MRI.  Micro-US found 10% additional csPCa that were missed by all other techniques. 
• Claros et al. 2020, Journal of Urology:
  Real-time visualization of MRI targets on ExactVu yielded higher rate of csPCa than robotic fusion biopsy (p=0.02). 
• Harland and Stenzl 2020, Prostate International: 
  A review article summarizing the state of the art in micro-ultrasound, covering comparison to mpMRI as well as utility for staging both prostate and bladder cancer. 
• Sountoulides et al. 2021, Journal of Urology: 
  Systematic review and meta-analysis of 18 studies covering 1125 biopsy cases concluding that micro-ultrasound-guided biopsy provides comparable detection rates for csPCa diagnosis with the mpMRI-guided biopsy. 
• Montorsi et al. 2021, Canadian Urology Association Journal:
  Letter responding to Klotz et al. 2020 CUAJ agreeing that micro-ultrasound has the “potential to become the first-level test for patients with a clinical suspicion of prostate cancer,” and confirming that their “initial experience has been similar to that reported” which suggests the results are reproducible and may have low variability between centers. 

“Despite the global pandemic, the past year has shown unprecedented growth and academic interest in micro-ultrasound with many important new publications in well-respected, high-impact journals,” says Dr. Brian Wodlinger, VP Engineering and Clinical.  “With your help, we look forward to solidifying the role of micro-ultrasound as the imaging method of choice for early diagnosis.” 

About Exact Imaging:

Exact Imaging (www.exactimaging.com) 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. Exact Imaging’s ExactVu™ micro-ultrasound platform operates at 29 MHz and enables a whole new level of resolution with the benefits of ease of use, affordability, and is an extension of the current urological workflow. Using the Exact Imaging platform, urologists are able to visualize areas of interest in the prostate and specifically target biopsies at 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. The ExactVu micro-ultrasound system including the FusionVu 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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