TORONTO, ON-- (Wednesday, November 23, 2016) Exact Imaging (www.exactimaging.com), the world’s leader in high resolution micro-ultrasound systems enabling real-time imaging and biopsy guidance of the prostate, today announced that it has received CE Mark approval for its ExactVu™ system for prostate imaging and biopsy guidance.
“We are thrilled with the achievement of CE Mark approval for our ExactVu system, which is the culmination of many years of technical development”, said Randy AuCoin, Exact Imaging’s President and CEO. “There is significant built-up demand for acquiring the ExactVu instrument and this approval will allow us to be able to commercialize our platform in Europe. With the ExactVu platform, urologists will have a new level of real-time resolution to facilitate actually targeting their prostate biopsies at suspicious regions. The goal is to provide the best tools to help the urologist make the most informed decisions and ultimately, to improve patient outcomes”.
The ExactVu micro-ultrasound is a novel platform for prostate imaging and biopsies with unmatched real-time resolution (down to 70 microns). The system’s high resolution derives from its operating frequency of 29 MHz, which is in comparison to usual operating frequencies of conventional ultrasound systems of 9 – 12 MHz. Due to this significant increase in resolution, the ExactVu system enables the urologist to visualize suspicious regions and in addition to performing systematic biopsies, can also perform biopsies targeted at suspicious regions in the prostate.
Exact Imaging is in the process of expanding its European direct sales, clinical applications and technical support operations and will shortly be announcing its new European headquarters that will be based in Belgium.
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 being an extension of the current urological workflow. Using the Exact Imaging platform, urologists will now be able to visualize areas of interest in the prostate and specifically target biopsies at those areas in addition to performing systematic, trans-rectal, ultrasound biopsy protocols. ExactVu™ micro-ultrasound system is available for sale in the European Union (CE Mark) and the United States (FDA 510(k) clearance). The product is not yet commercially available in Canada. The company was founded in 2013 by Sam Ifergan (iGan Partners) and Randy AuCoin to develop and commercialize this novel high-resolution technology to disrupt the market and enable new levels of clinical imaging.
