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 News Release - September 10, 2019

Exact Imaging's Transperineal Needle Guide Release Receives CE Mark

New Sterile Transperineal Needle Guide enables the ExactVu™ micro-ultrasound system to be used across Europe and in clinical settings requiring Transperineal access

TORONTO, Sept. 10, 2019 -- (Healthcare Sales & Marketing Network) - 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, announced it has received CE Mark for its Sterile Transperineal Needle Guide for use with Exact Imaging EV29L transducer. Operating on the ExactVu micro-ultrasound system, the Sterile Transperineal Needle Guide now allows urologists to perform targeted prostate biopsies leveraging the near microscopic resolution of the micro-ultrasound for transperineal-based biopsies. The ExactVu system provides the highest real-time resolution for guidance of prostate biopsies and with the growth of demand for the ExactVu systems in European markets and facilities that favor transperineal approaches for prostate biopsies, the ExactVu system is now able to be used in those clinical settings.

"The ability to perform targeted transperineal biopsies guided by ExactVu 29 MHz micro-ultrasound represents a real breakthrough by virtue of being able to image the target volume in real-time in the office", says Professor Mark Emberton, Professor of Interventional Oncology, Division of Surgery and Interventional Science, University College London (UCL) and Clinical Director, Clinical Effectiveness Unit, Royal College of Surgeons of England.

"In some markets there is increasing movement towards transperineal-based biopsies, with the aim of reducing rates of infection", said Randy AuCoin, Exact Imaging's President and CEO. "With the CE Mark for our new Sterile Transperineal Needle Guide, the ExactVu micro-ultrasound system can now be used in all clinical settings for targeted prostate biopsies, including FusionVu™ and cognitive fusion biopsies."

The ExactVu micro-ultrasound system, its FusionVu application and the newly released Sterile Transperineal Needle Guide will be showcased live at the forthcoming major European urology meetings, DGU 2019 in Hamburg, SIU 2019 Congress in Athens, ESUI19 / EMUC19 in Vienna, and AFU 2019 in Paris. For further details, go to www.exactimaging.com

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 has received regulatory approval in the European Union (CE Mark), the United States (FDA 510(k)), and Canada (Health Canada medical device license).


Source: Exact Imaging

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